Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43876   clinical trials with a EudraCT protocol, of which   7294   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    The effect of intravenous iron on postoperative transfusion requirements in hip fracture patients – a pilot study

    Summary
    EudraCT number
    		 2011-003233-34
    Trial protocol
    		 GB  
    Global end of trial date
    11 Jul 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    27 Feb 2019
    First version publication date
    27 Feb 2019
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    11048
    Additional study identifiers
    ISRCTN number
    		 ISRCTN89812075
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    University of Nottingham
    Sponsor organisation address
    East Atrium; Jubilee Conference Centre; Triumph Road, Nottingham, United Kingdom, NG8 1DH
    Public contact
    Iain Moppett, University of Nottingham, +44 01158230959, iain.moppett@nottingham.ac.uk
    Scientific contact
    Iain Moppett, University of Nottingham, +44 1158230959, iain.moppett@nottingham.ac.uk
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    14 Nov 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    11 Jul 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    11 Jul 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To determine whether intravenous iron given in the first few days following hip fracture is effective in stimulating red cell production.
    Protection of trial subjects
    No change to standard care for any participants in study, except for IMP and seven days of blood tests. Consent confirmed for each administration of IMP. All study personnel trained in trial conduct and ethics.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    03 Oct 2011
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 80
    Worldwide total number of subjects
    80
    EEA total number of subjects
    80
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    0
    From 65 to 84 years
    53
    85 years and over
    27

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 First participant recruited 19/7/2012 Last participant recruited 26/6/2017

    Pre-assignment
    Screening details
    		 Potential participants screened in emergency department based on age, injury and major inclusion / exclusion criteria (inability to provide own consent). Excluded (n = 1324)​ Not meeting inclusion criteria (n = 1166)​ Unable to give consent (n = 359)​ >24 hours (n = 349)​ Declined to participate (n = 158)​ Other reasons (n = 0)

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Single blind [1]
    Roles blinded
    		 Monitor, Data analyst, Investigator, Assessor [2]
    Blinding implementation details
    Participants not blinded due to colour of IMP. Assessor blinded except in case of adjudication of serious adverse reactions

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Control
    Arm description
    		 Control group
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Intravenous iron
    Arm description
    		 Intravenous iron
    Arm type
    		 Experimental

    Investigational medicinal product name
    VENOFER
    Investigational medicinal product code
    Other name
    Iron sucrose
    Pharmaceutical forms
    Concentrate for solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    IMP administration Patients allocated to IMP will receive 200mg iron sucrose (Venofer) on three separate occasions: T1: Day 1 (within 24 hours of admission); T2: Day 1 postop; or second morning following admission if not yet gone to theatre T3: Day 2 postop; or third morning following admission if not yet gone to theatre Administration of intravenous iron will be in accordance with manufacturer’s recommendations. 10ml Venofer (200 mg iron) will be diluted in 100 ml 0.9% sodium chloride for injections. (Final concentration 1 mg/ml) The infusion will be given at an infusion rate of not more than 50 ml in 15 minutes. Oral iron is prohibited for at least 5 days following administration of intravenous iron. Given the negative results of a recent study of oral iron in hip fracture10, oral iron will not be permitted for any study participants until day 10.

    Notes
    [1] - The number of roles blinded appears inconsistent with a single blinded trial. It is expected that there will be one role blinded in a single blind trial.
    Justification: Investigators and analysts blinded to allocation. Participants not blinded due to colour of IMP.
    [2] - The roles blinded appear inconsistent with a simple blinded trial.
    Justification: Investigators and analysts blinded to allocation. Participants not blinded due to colour of IMP.
    Number of subjects in period 1
    		Control Intravenous iron
    Started
    41
    39
    Completed
    41
    39

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Control
    Reporting group description
    		 Control group

    Reporting group title
    Intravenous iron
    Reporting group description
    		 Intravenous iron

    Reporting group values
    		 Control Intravenous iron Total
    Number of subjects
    		 41 39 80
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0
        Newborns (0-27 days)
    		 0
        Infants and toddlers (28 days-23 months)
    		 0
        Children (2-11 years)
    		 0
        Adolescents (12-17 years)
    		 0
        Adults (18-64 years)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Age of participants at study entry
    Units: years
        arithmetic mean (standard deviation)
    		 82.5 ± 5.8 81.2 ± 7.0 -
    Gender categorical
    Units: Subjects
        Female
    		 29 24 53
        Male
    		 12 15 27
    Admission source
    Location participicant was admitted to hospital from
    Units: Subjects
        Home – Independent
    		 36 36 72
        Nursing care
    		 0 1 1
        Residential care
    		 1 0 1
        Warden controlled
    		 4 2 6
    Operation
    Operation type
    Units: Subjects
        AO Screws
    		 2 1 3
        DHS
    		 14 9 23
        Hemiarthroplasty
    		 18 22 40
        Nail
    		 2 4 6
        Total Hip Arthroplasty
    		 5 3 8
    Fracture type
    Type of hip fracture
    Units: Subjects
        Extracapsular
    		 6 3 9
        Intracapsular
    		 24 26 50
        Trochanteric
    		 11 10 21
    Haemoglobin concentration on admission < 120 g / L
    Number of subjects with a haemoglobin concentration level of less than 120 g / L on admission to hospital
    Units: Subjects
        Yes
    		 15 16 31
        No
    		 26 23 49
    Time to theatre
    Time from participant admission to hospital until arrival at theatre
    Units: hour
        arithmetic mean (standard deviation)
    		 29.8 ± 20 29.7 ± 17 -
    Haemoglobin concentration on admission
    Haemoglobin concentration on admission to hospital
    Units: g / L
        log mean (standard deviation)
    		 4.83 ± 0.11 4.81 ± 0.16 -
    Haemoglobin concentration on admission
    Haemoglobin concentration on admission to hospital
    Units: g / L
        arithmetic mean (inter-quartile range (Q1-Q3))
    		 125.4 (121.4 to 129.6) 122.4 (116.5 to 128.6) -
    Reticulocyte count day 1
    Reticulocyte count on day 1
    Units: 10^9 cells / L
        log mean (standard deviation)
    		 3.70 ± 0.28 3.74 ± 0.30 -
    Reticulocyte count day 1
    Reticulocyte count on day 1
    Units: 10^9 cells / L
        arithmetic mean (inter-quartile range (Q1-Q3))
    		 40.4 (36.9 to 44.2) 42.2 (38.3 to 46.6) -
    Reticulocyte index day 1
    Reticulocyte index on day 1
    Units: percent
        log mean (standard deviation)
    		 0.10 ± 0.32 0.15 ± 0.36 -
    Reticulocyte index day 1
    Reticulocyte index on day 1
    Units: percent
        arithmetic mean (inter-quartile range (Q1-Q3))
    		 1.11 (1.00 to 1.23) 1.16 (1.03 to 1.3) -
    Haemoglobin concentration day 1
    Haemoglobin concentration on day 1
    Units: g / L
        log mean (standard deviation)
    		 4.72 ± 0.18 4.71 ± 0.20 -
    Haemoglobin concentration day 1
    Haemoglobin concentration on day 1
    Units: g / L
        arithmetic mean (inter-quartile range (Q1-Q3))
    		 112.7 (106.4 to 119.3) 111.1 (104.1 to 118.6) -

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Control
    Reporting group description
    		 Control group

    Reporting group title
    Intravenous iron
    Reporting group description
    		 Intravenous iron

    Subject analysis set title
    Full analysis
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All participants randomised

    Primary: Reticulocyte count on final day following admission

    		 Close Top of page
    End point title
    		 Reticulocyte count on final day following admission
    End point description
    End point type
    Primary
    End point timeframe
    Final day
    End point values
    		 Control Intravenous iron
    Number of subjects analysed
    37
    35
    Units: 10^9 cells / L
        log mean (standard deviation)
    4.28 ± 0.38
    4.49 ± 0.38
    Statistical analysis title
    		 Comparison of log mean final reticulocyte count
    Statistical analysis description
    Two-sided t-test to test for significance in log mean final reticulocyte count
    Comparison groups
    Intravenous iron v Control
    Number of subjects included in analysis
    72
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.019
    Method
    		 t-test, 2-sided
    Confidence interval

    Primary: Reticulocyte count on final day following admission

    		 Close Top of page
    End point title
    		 Reticulocyte count on final day following admission [1]
    End point description
    End point type
    Primary
    End point timeframe
    Final day
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Fields used to provide details for back-transformed data, analysis performed on log transformed data.
    End point values
    		 Control Intravenous iron
    Number of subjects analysed
    37
    35
    Units: 10^9 cells / L
        arithmetic mean (inter-quartile range (Q1-Q3))
    72.2 (63.9 to 86.4)
    89.4 (78.9 to 101.3)
    No statistical analyses for this end point

    Primary: Reticulocyte index on final day following admission

    		 Close Top of page
    End point title
    		 Reticulocyte index on final day following admission
    End point description
    End point type
    Primary
    End point timeframe
    Final day
    End point values
    		 Control Intravenous iron
    Number of subjects analysed
    37
    35
    Units: percent
        log mean (standard deviation)
    0.77 ± 0.42
    0.99 ± 0.35
    Statistical analysis title
    		 Comparison of log mean final reticulocyte index
    Statistical analysis description
    Two-sided t-test to test for significance in log mean final reticulocyte index
    Comparison groups
    Control v Intravenous iron
    Number of subjects included in analysis
    72
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.022
    Method
    		 t-test, 2-sided
    Confidence interval

    Primary: Reticulocyte index on final day following admission

    		 Close Top of page
    End point title
    		 Reticulocyte index on final day following admission [2]
    End point description
    End point type
    Primary
    End point timeframe
    Final day
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Fields used to provide details for back-transformed data, analysis performed on log transformed data.
    End point values
    		 Control Intravenous iron
    Number of subjects analysed
    37
    35
    Units: percent
        arithmetic mean (inter-quartile range (Q1-Q3))
    2.19 (1.91 to 2.51)
    2.69 (2.39 to 3.03)
    No statistical analyses for this end point

    Secondary: Haemoglobin concentration on final day following admission

    		 Close Top of page
    End point title
    		 Haemoglobin concentration on final day following admission
    End point description
    End point type
    Secondary
    End point timeframe
    Final day
    End point values
    		 Control Intravenous iron
    Number of subjects analysed
    38
    36
    Units: g / L
        log mean (standard deviation)
    4.60 ± 0.14
    4.62 ± 0.10
    Statistical analysis title
    		 Comparison of log mean final haemoglobin
    Statistical analysis description
    Two-sided t-test to test for significance in log mean final haemoglobin concentration
    Comparison groups
    Control v Intravenous iron
    Number of subjects included in analysis
    74
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.454
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Haemoglobin concentration on final day following admission

    		 Close Top of page
    End point title
    		 Haemoglobin concentration on final day following admission
    End point description
    End point type
    Secondary
    End point timeframe
    Final day
    End point values
    		 Control Intravenous iron
    Number of subjects analysed
    38
    36
    Units: g / L
        arithmetic mean (inter-quartile range (Q1-Q3))
    99.9 (95.7 to 104.2)
    102.0 (98.7 to 105.3)
    No statistical analyses for this end point

    Secondary: Minimum recorded haemoglobin concentration within the first 7 days following admission

    		 Close Top of page
    End point title
    		 Minimum recorded haemoglobin concentration within the first 7 days following admission
    End point description
    End point type
    Secondary
    End point timeframe
    Within first 7 days following admission
    End point values
    		 Control Intravenous iron
    Number of subjects analysed
    41
    39
    Units: g / L
        log mean (standard deviation)
    4.51 ± 0.16
    4.52 ± 0.14
    Statistical analysis title
    		 Comparison of log mean minimum haemoglobin
    Statistical analysis description
    Two-sided t-test to test for significance in log mean minimum haemoglobin concentration during the first 7 days following admission to hospital
    Comparison groups
    Control v Intravenous iron
    Number of subjects included in analysis
    80
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.638
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Minimum recorded haemoglobin concentration within the first 7 days following admission

    		 Close Top of page
    End point title
    		 Minimum recorded haemoglobin concentration within the first 7 days following admission
    End point description
    End point type
    Secondary
    End point timeframe
    Within first 7 days following admission
    End point values
    		 Control Intravenous iron
    Number of subjects analysed
    41
    39
    Units: g / L
        arithmetic mean (inter-quartile range (Q1-Q3))
    90.6 (86.1 to 95.2)
    92.1 (88.0 to 96.2)
    No statistical analyses for this end point

    Secondary: Maximum recorded fall in haemoglobin concentration within the first 7 days following admission

    		 Close Top of page
    End point title
    		 Maximum recorded fall in haemoglobin concentration within the first 7 days following admission
    End point description
    End point type
    Secondary
    End point timeframe
    Within first 7 days following admission
    End point values
    		 Control Intravenous iron
    Number of subjects analysed
    41
    39
    Units: g / L
        log mean (standard deviation)
    3.39 ± 0.69
    3.23 ± 0.74
    Statistical analysis title
    		 Comparison of log mean maximum fall in haemoglobin
    Statistical analysis description
    Two-sided t-test to test for significance in log mean maximum fall in haemoglobin concentration during the first 7 days following admission to hospital
    Comparison groups
    Control v Intravenous iron
    Number of subjects included in analysis
    80
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.344
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Maximum recorded fall in haemoglobin concentration within the first 7 days following admission

    		 Close Top of page
    End point title
    		 Maximum recorded fall in haemoglobin concentration within the first 7 days following admission
    End point description
    End point type
    Secondary
    End point timeframe
    Within first 7 days following admission
    End point values
    		 Control Intravenous iron
    Number of subjects analysed
    41
    39
    Units: g / L
        arithmetic mean (inter-quartile range (Q1-Q3))
    29.5 (23.9 to 36.5)
    25.3 (20.0 to 32.1)
    No statistical analyses for this end point

    Secondary: Maximum recorded reticulocyte count within the first 7 days following admission

    		 Close Top of page
    End point title
    		 Maximum recorded reticulocyte count within the first 7 days following admission
    End point description
    End point type
    Secondary
    End point timeframe
    Within first 7 days following admission
    End point values
    		 Control Intravenous iron
    Number of subjects analysed
    41
    39
    Units: 10^9 cells / L
        log mean (standard deviation)
    4.29 ± 0.34
    4.49 ± 0.36
    Statistical analysis title
    		 Comparison of log mean maximum reticulocyte count
    Statistical analysis description
    Two-sided t-test to test for significance in log mean maximum reticulocyte count during the first 7 days following admission to hospital
    Comparison groups
    Control v Intravenous iron
    Number of subjects included in analysis
    80
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.022
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Maximum recorded reticulocyte count within the first 7 days following admission

    		 Close Top of page
    End point title
    		 Maximum recorded reticulocyte count within the first 7 days following admission
    End point description
    End point type
    Secondary
    End point timeframe
    Within first 7 days following admission
    End point values
    		 Control Intravenous iron
    Number of subjects analysed
    41
    39
    Units: 10^9 cells / L
        arithmetic mean (inter-quartile range (Q1-Q3))
    72.7 (66.5 to 80.6)
    88.8 (79.3 to 99.4)
    No statistical analyses for this end point

    Secondary: Maximum recorded reticulocyte index within the first 7 days following admission

    		 Close Top of page
    End point title
    		 Maximum recorded reticulocyte index within the first 7 days following admission
    End point description
    End point type
    Secondary
    End point timeframe
    Within first 7 days following admission
    End point values
    		 Control Intravenous iron
    Number of subjects analysed
    41
    39
    Units: percent
        log mean (standard deviation)
    0.78 ± 0.40
    0.97 ± 0.36
    Statistical analysis title
    		 Comparison of log mean maximum reticulocyte index
    Statistical analysis description
    Two-sided t-test to test for significance in log mean maximum reticulocyte index during the first 7 days following admission to hospital
    Comparison groups
    Intravenous iron v Control
    Number of subjects included in analysis
    80
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.022
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Maximum recorded reticulocyte index within the first 7 days following admission

    		 Close Top of page
    End point title
    		 Maximum recorded reticulocyte index within the first 7 days following admission
    End point description
    End point type
    Secondary
    End point timeframe
    Within first 7 days following admission
    End point values
    		 Control Intravenous iron
    Number of subjects analysed
    41
    39
    Units: percent
        arithmetic mean (inter-quartile range (Q1-Q3))
    2.17 (1.92 to 2.46)
    2.63 (2.35 to 2.94)
    No statistical analyses for this end point

    Secondary: Serum Transferrin Receptor Concentration final day following admission

    		 Close Top of page
    End point title
    		 Serum Transferrin Receptor Concentration final day following admission
    End point description
    End point type
    Secondary
    End point timeframe
    Final day
    End point values
    		 Control Intravenous iron
    Number of subjects analysed
    29
    23
    Units: mg / L
        median (inter-quartile range (Q1-Q3))
    17.4 (14.5 to 19)
    16.1 (14.1 to 17.9)
    Statistical analysis title
    		 Comparison of mean Serum Transferrin Receptor
    Statistical analysis description
    Chi-squared test for significance in mean Serum Transferrin Receptor Concentration on the final day
    Comparison groups
    Control v Intravenous iron
    Number of subjects included in analysis
    52
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.418
    Method
    		 Chi-squared
    Confidence interval

    Secondary: Serum Transferrin Receptor Concentration final day following admission

    		 Close Top of page
    End point title
    		 Serum Transferrin Receptor Concentration final day following admission
    End point description
    End point type
    Secondary
    End point timeframe
    Final day
    End point values
    		 Control Intravenous iron
    Number of subjects analysed
    29
    23
    Units: mg / L
        median (full range (min-max))
    17.4 (10.1 to 24.8)
    16.1 (9.3 to 24.8)
    No statistical analyses for this end point

    Secondary: Total transfusions during admission

    		 Close Top of page
    End point title
    		 Total transfusions during admission
    End point description
    End point type
    Secondary
    End point timeframe
    During admission
    End point values
    		 Control Intravenous iron
    Number of subjects analysed
    41
    39
    Units: Transfusion
        median (inter-quartile range (Q1-Q3))
    0 (0 to 1)
    0 (0 to 1)
    Statistical analysis title
    		 Comparison of total transfusions during admission
    Statistical analysis description
    Mann-Whitney test for significance of difference of total transfusions during admission to hospital
    Comparison groups
    Control v Intravenous iron
    Number of subjects included in analysis
    80
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.927
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Total transfusions during admission

    		 Close Top of page
    End point title
    		 Total transfusions during admission
    End point description
    End point type
    Secondary
    End point timeframe
    During admission
    End point values
    		 Control Intravenous iron
    Number of subjects analysed
    41
    39
    Units: Transfusion
        median (full range (min-max))
    0 (0 to 4)
    0 (0 to 4)
    No statistical analyses for this end point

    Secondary: Participants transfused during admission

    		 Close Top of page
    End point title
    		 Participants transfused during admission
    End point description
    End point type
    Secondary
    End point timeframe
    During admission
    End point values
    		 Control Intravenous iron
    Number of subjects analysed
    41
    39
    Units: Participants transfused
    12
    11
    Statistical analysis title
    		 Comparison of number of participants infused
    Statistical analysis description
    Chi-squared test for significance in number of participants infused during admission to hospital
    Comparison groups
    Intravenous iron v Control
    Number of subjects included in analysis
    80
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 1
    Method
    		 Chi-squared
    Confidence interval

    Secondary: Total transfusions in first week

    		 Close Top of page
    End point title
    		 Total transfusions in first week
    End point description
    End point type
    Secondary
    End point timeframe
    During first week
    End point values
    		 Control Intravenous iron
    Number of subjects analysed
    41
    39
    Units: Transfusions
        median (inter-quartile range (Q1-Q3))
    0 (0 to 1)
    0 (0 to 1)
    Statistical analysis title
    		 Comparison of total transfusions during first week
    Statistical analysis description
    Chi-squared test for significance in mean of total transfusions during first week in hospital
    Comparison groups
    Intravenous iron v Control
    Number of subjects included in analysis
    80
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.899
    Method
    		 Chi-squared
    Confidence interval

    Secondary: Total transfusions in first week

    		 Close Top of page
    End point title
    		 Total transfusions in first week
    End point description
    End point type
    Secondary
    End point timeframe
    During the first week
    End point values
    		 Control Intravenous iron
    Number of subjects analysed
    41
    39
    Units: Transfusions
        median (full range (min-max))
    0 (0 to 4)
    0 (0 to 4)
    No statistical analyses for this end point

    Secondary: Participants transfused during first week

    		 Close Top of page
    End point title
    		 Participants transfused during first week
    End point description
    End point type
    Secondary
    End point timeframe
    During the first week
    End point values
    		 Control Intravenous iron
    Number of subjects analysed
    41
    39
    Units: Participants transfused
    11
    11
    Statistical analysis title
    		 Comparison of number of participants infused
    Statistical analysis description
    Mann-Whitney-U test for significance in number of participants infused during the first week in hospital
    Comparison groups
    Control v Intravenous iron
    Number of subjects included in analysis
    80
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 1
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Infective complications

    		 Close Top of page
    End point title
    		 Infective complications
    End point description
    End point type
    Secondary
    End point timeframe
    During length of study
    End point values
    		 Control Intravenous iron
    Number of subjects analysed
    41
    39
    Units: Participants
    12
    8
    Statistical analysis title
    		 Comparison of number of infective complications
    Statistical analysis description
    Mann-Whitney-U test for significance in number of infective complications
    Comparison groups
    Control v Intravenous iron
    Number of subjects included in analysis
    80
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.518
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Cardiovascular complications

    		 Close Top of page
    End point title
    		 Cardiovascular complications
    End point description
    End point type
    Secondary
    End point timeframe
    During length of study
    End point values
    		 Control Intravenous iron
    Number of subjects analysed
    41
    39
    Units: Participants
    10
    9
    Statistical analysis title
    		 Comparison of number cardiovascular complications
    Statistical analysis description
    Mann-Whitney-U test for significance in number of cardiovascular complications
    Comparison groups
    Control v Intravenous iron
    Number of subjects included in analysis
    80
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 1
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Cumulated ambulation score

    		 Close Top of page
    End point title
    		 Cumulated ambulation score
    End point description
    End point type
    Secondary
    End point timeframe
    Days 1 to 3
    End point values
    		 Control Intravenous iron
    Number of subjects analysed
    41
    39
    Units: Score
        median (inter-quartile range (Q1-Q3))
    43.5 (24 to 56)
    32 (19.2 to 48)
    Statistical analysis title
    		 Comparison of cumulated ambulation score
    Statistical analysis description
    Chi-squared test for significance in mean of cumulated ambulation score
    Comparison groups
    Control v Intravenous iron
    Number of subjects included in analysis
    80
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.137
    Method
    		 Chi-squared
    Confidence interval

    Secondary: Cumulated ambulation score

    		 Close Top of page
    End point title
    		 Cumulated ambulation score
    End point description
    End point type
    Secondary
    End point timeframe
    Days 1 to 3
    End point values
    		 Control Intravenous iron
    Number of subjects analysed
    41
    39
    Units: Score
        median (full range (min-max))
    43.5 (8 to 82)
    32 (0 to 85)
    No statistical analyses for this end point

    Secondary: Length of hospital stay

    		 Close Top of page
    End point title
    		 Length of hospital stay
    End point description
    End point type
    Secondary
    End point timeframe
    Duration of the study
    End point values
    		 Control Intravenous iron
    Number of subjects analysed
    41
    39
    Units: day
        log mean (standard deviation)
    2.66 ± 0.45
    2.60 ± 0.54
    Statistical analysis title
    		 Comparison of log mean length of hospital stay
    Statistical analysis description
    Two-sided t-test to test for significance in log mean length of hospital stay
    Comparison groups
    Control v Intravenous iron
    Number of subjects included in analysis
    80
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.605
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Length of hospital stay

    		 Close Top of page
    End point title
    		 Length of hospital stay
    End point description
    End point type
    Secondary
    End point timeframe
    Duration of the study
    End point values
    		 Control Intravenous iron
    Number of subjects analysed
    41
    39
    Units: day
        arithmetic mean (inter-quartile range (Q1-Q3))
    14.2 (12.4 to 16.4)
    13.4 (11.4 to 15.9)
    No statistical analyses for this end point

    Secondary: Length of postoperative hospital stay

    		 Close Top of page
    End point title
    		 Length of postoperative hospital stay
    End point description
    End point type
    Secondary
    End point timeframe
    Period remain hospitalised following operation
    End point values
    		 Control Intravenous iron
    Number of subjects analysed
    41
    39
    Units: day
        log mean (standard deviation)
    2.56 ± 0.48
    2.48 ± 0.59
    Statistical analysis title
    		 Comparison of log mean length of hospital stay
    Statistical analysis description
    Two-sided t-test to test for significance in log mean length of postoperative hospital stay
    Comparison groups
    Control v Intravenous iron
    Number of subjects included in analysis
    80
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.527
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Length of postoperative hospital stay

    		 Close Top of page
    End point title
    		 Length of postoperative hospital stay
    End point description
    End point type
    Secondary
    End point timeframe
    Period remain hospitalised following operation
    End point values
    		 Control Intravenous iron
    Number of subjects analysed
    41
    39
    Units: day
        arithmetic mean (inter-quartile range (Q1-Q3))
    12.9 (11.1 to 15)
    12 (9.9 to 14.4)
    No statistical analyses for this end point

    Secondary: Discharge destination

    		 Close Top of page
    End point title
    		 Discharge destination
    End point description
    End point type
    Secondary
    End point timeframe
    Discharge from hospital
    End point values
    		 Control Intravenous iron
    Number of subjects analysed
    41
    39
    Units: Participants
        Died
    0
    3
        Nursing Home
    1
    2
        Own Home
    27
    25
        Rehab hospital
    11
    7
        Residential Home
    1
    2
        Warden controlled accommodation
    1
    0
    Statistical analysis title
    		 Comparison of type of discharge destination
    Statistical analysis description
    Mann-Whitney-U test for significance in type of discharge destination
    Comparison groups
    Control v Intravenous iron
    Number of subjects included in analysis
    80
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.349
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Mortality at 30-days

    		 Close Top of page
    End point title
    		 Mortality at 30-days
    End point description
    End point type
    Secondary
    End point timeframe
    30-days post randomisation
    End point values
    		 Control Intravenous iron
    Number of subjects analysed
    41
    39
    Units: Participant
    0
    4
    Statistical analysis title
    		 Comparison of mortality at 30 days
    Statistical analysis description
    Chi-square test for significance in mortality at 30 days
    Comparison groups
    Control v Intravenous iron
    Number of subjects included in analysis
    80
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.112
    Method
    		 Chi-squared
    Confidence interval

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    From randomisation to the day 7 assessment
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.0
    Reporting groups
    Reporting group title
    Control
    Reporting group description
    		 Control group

    Reporting group title
    Intravenous iron
    Reporting group description
    		 Intravenous iron

    Serious adverse events
    		 Control Intravenous iron
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 41 (9.76%)
    6 / 39 (15.38%)
         number of deaths (all causes)
    0
    3
         number of deaths resulting from adverse events
    0
    3
    Injury, poisoning and procedural complications
    Femoral neck fracture
    Additional description: The participant independently went to the bathroom. They were heard shouting and were found lying on the floor. They had pain itn the right leg/hip and a small skin tear on their right elbow. A pelvic x-ray showed a right fractured neck of femur.
         subjects affected / exposed
    1 / 41 (2.44%)
    0 / 39 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Cardiac failure congestive
    Additional description: The participant had known congestive heart failure. They developed worsening congestive heart failure with a probable chest infection. Last dose of IMP was administered 7 days prior to event onset date.
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 39 (2.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Arrhythmia
    Additional description: Participant 1: Tachycardia; hypotension. Tachycardia worsened to 146 bpm. History of SVT. Venofer given without AE. Participant 2: Developed a cardiac arrythmia, supraventricular tachycardia, resulting in hypotension
         subjects affected / exposed
    0 / 41 (0.00%)
    2 / 39 (5.13%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Lower respiratory tract infection
    Additional description: Participant 1: Hypoxic Participant 2: Hospital acquired pneumonia. Also had heart failure. Participant 3: Known congestive heart failure. Worsened plus probable chest infection. Last dose of IMP was administered 7 days prior to event onset date.
         subjects affected / exposed
    2 / 41 (4.88%)
    1 / 39 (2.56%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infective exacerbation of chronic obstructive airways disease
    Additional description: Participant 1: Had a fall. Had basal crackles;tachycardia;a head injury. A chest infection deemed; antibiotics given. Resulted in infective exacerbation of COPD. Participant 2: Tachycardic post-operatively. Worsening shortness of breath
         subjects affected / exposed
    0 / 41 (0.00%)
    2 / 39 (5.13%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Pneumonia bacterial
    Additional description: The participant had abdominal discomfort; had CTPA showing pleural effusions; bi-basal consolidation with atelectasis. Received antibiotics (levofloxacin) for hospital acquired pneumonia.They had nausea (increased), constipation and shallow breathing
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 39 (2.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis norovirus
    Additional description: The participant developed vomiting and and diarrhoea (severe). It was likely a secondary norovirus infection. There had been an outbreak of norovirus on the ward where the patient was being nursed.
         subjects affected / exposed
    1 / 41 (2.44%)
    0 / 39 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0.05%
    Non-serious adverse events
    		 Control Intravenous iron
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 41 (0.00%)
    7 / 39 (17.95%)
    Surgical and medical procedures
    Hypotension
    Additional description: The participant was hypotensive on return from surgery on day 2. Blood pressue pre-administration was 96 / 56 mmHg. Blood pressure post-administration was 99 / 63 mmHg.
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 39 (2.56%)
         occurrences all number
    0
    1
    General disorders and administration site conditions
    Pyrexia
    Additional description: Participant 1: Research team made the decision not to give study medication. Participant to be reviewed by doctor regarding pyrexia. Participant 2: IMP was not given on the grounds of patient safety. The participant will be observed.
         subjects affected / exposed
    0 / 41 (0.00%)
    2 / 39 (5.13%)
         occurrences all number
    0
    2
    Eye disorders
    Vision blurred
    Additional description: Participant developed blurred vision shortly after commencing infustion. Venofer discontinued.
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 39 (2.56%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Nausea
    Additional description: Participant said she felt very "queasy" following the iron infusion administered on day 1. This increased post infusion.
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 39 (2.56%)
         occurrences all number
    0
    1
    Skin and subcutaneous tissue disorders
    Pruritus
    Additional description: Participant had itching following IMP administration on day 1.No evidence of a rash post-operation.They received spinal and diamorphine in theatre. PI deems likely to be associated with analgesia. Participant withdrew from further IMP administration.
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 39 (2.56%)
         occurrences all number
    0
    1
    Injection site irritation
    Additional description: Participant declined to have third dose of Venofer. Claimed second dose stung too much and problems with cannulae were related to iron. They remained in the study and had seven day blood tests.
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 39 (2.56%)
         occurrences all number
    0
    1

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    24 May 2013
    Addition of Heart of England NHS Foundation Trust hospital in Birmingham as a second site.
    28 Oct 2013
    Temporary halt for review
    13 Mar 2014
    Study restart following temporary halt.

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    01 Oct 2013
    Temporay halt for review following three deaths in the treatment arm. All deaths are considered by research team to be unrelated to trial participation (the trial population is frail elderly; the causes of death are not related to intravenous iron). These death cases were independently reviewed during which time there was a temporary suspension.
    10 Dec 2013

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/24015990
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Sat May 11 04:25:23 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA