Clinical Trial Results:
The effect of intravenous iron on postoperative transfusion requirements in hip fracture patients – a pilot study
Summary
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EudraCT number |
2011-003233-34 |
Trial protocol |
GB |
Global end of trial date |
11 Jul 2017
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Results information
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Results version number |
v1(current) |
This version publication date |
27 Feb 2019
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First version publication date |
27 Feb 2019
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Other versions |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
11048
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Additional study identifiers
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ISRCTN number |
ISRCTN89812075 | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
University of Nottingham
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Sponsor organisation address |
East Atrium; Jubilee Conference Centre; Triumph Road, Nottingham, United Kingdom, NG8 1DH
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Public contact |
Iain Moppett, University of Nottingham, +44 01158230959, iain.moppett@nottingham.ac.uk
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Scientific contact |
Iain Moppett, University of Nottingham, +44 1158230959, iain.moppett@nottingham.ac.uk
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
14 Nov 2018
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
11 Jul 2017
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Global end of trial reached? |
Yes
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Global end of trial date |
11 Jul 2017
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Was the trial ended prematurely? |
No
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General information about the trial
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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.
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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.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
03 Oct 2011
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
United Kingdom: 80
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Worldwide total number of subjects |
80
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EEA total number of subjects |
80
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
0
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From 65 to 84 years |
53
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85 years and over |
27
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Recruitment
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Recruitment details |
First participant recruited 19/7/2012 Last participant recruited 26/6/2017 | |||||||||
Pre-assignment
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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
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Period 1 title |
Overall trial (overall period)
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Is this the baseline period? |
Yes | |||||||||
Allocation method |
Randomised - controlled
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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
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Control | |||||||||
Arm description |
Control group | |||||||||
Arm type |
No intervention | |||||||||
Investigational medicinal product name |
No investigational medicinal product assigned in this arm
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Arm title
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Intravenous iron | |||||||||
Arm description |
Intravenous iron | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
VENOFER
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Investigational medicinal product code |
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Other name |
Iron sucrose
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Pharmaceutical forms |
Concentrate for solution for injection/infusion
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Routes of administration |
Intravenous use
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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.
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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. |
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Baseline characteristics reporting groups
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Reporting group title |
Control
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Reporting group description |
Control group | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Intravenous iron
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Reporting group description |
Intravenous iron | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Control
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Reporting group description |
Control group | ||
Reporting group title |
Intravenous iron
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Reporting group description |
Intravenous iron | ||
Subject analysis set title |
Full analysis
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Subject analysis set type |
Full analysis | ||
Subject analysis set description |
All participants randomised
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End point title |
Reticulocyte count on final day following admission | ||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Final day
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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
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Comparison groups |
Intravenous iron v Control
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Number of subjects included in analysis |
72
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Analysis specification |
Pre-specified
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Analysis type |
equivalence | ||||||||||||
P-value |
= 0.019 | ||||||||||||
Method |
t-test, 2-sided | ||||||||||||
Confidence interval |
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End point title |
Reticulocyte count on final day following admission [1] | ||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Final day
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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. |
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No statistical analyses for this end point |
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End point title |
Reticulocyte index on final day following admission | ||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Final day
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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
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Comparison groups |
Control v Intravenous iron
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Number of subjects included in analysis |
72
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Analysis specification |
Pre-specified
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Analysis type |
equivalence | ||||||||||||
P-value |
= 0.022 | ||||||||||||
Method |
t-test, 2-sided | ||||||||||||
Confidence interval |
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End point title |
Reticulocyte index on final day following admission [2] | ||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Final day
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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. |
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No statistical analyses for this end point |
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End point title |
Haemoglobin concentration on final day following admission | ||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
Final day
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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
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Comparison groups |
Control v Intravenous iron
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Number of subjects included in analysis |
74
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Analysis specification |
Pre-specified
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Analysis type |
equivalence | ||||||||||||
P-value |
= 0.454 | ||||||||||||
Method |
t-test, 2-sided | ||||||||||||
Confidence interval |
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End point title |
Haemoglobin concentration on final day following admission | ||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
Final day
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No statistical analyses for this end point |
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End point title |
Minimum recorded haemoglobin concentration within the first 7 days following admission | ||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
Within first 7 days following admission
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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
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Comparison groups |
Control v Intravenous iron
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Number of subjects included in analysis |
80
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Analysis specification |
Pre-specified
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Analysis type |
equivalence | ||||||||||||
P-value |
= 0.638 | ||||||||||||
Method |
t-test, 2-sided | ||||||||||||
Confidence interval |
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End point title |
Minimum recorded haemoglobin concentration within the first 7 days following admission | ||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
Within first 7 days following admission
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No statistical analyses for this end point |
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End point title |
Maximum recorded fall in haemoglobin concentration within the first 7 days following admission | ||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
Within first 7 days following admission
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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
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Comparison groups |
Control v Intravenous iron
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Number of subjects included in analysis |
80
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Analysis specification |
Pre-specified
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Analysis type |
equivalence | ||||||||||||
P-value |
= 0.344 | ||||||||||||
Method |
t-test, 2-sided | ||||||||||||
Confidence interval |
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End point title |
Maximum recorded fall in haemoglobin concentration within the first 7 days following admission | ||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
Within first 7 days following admission
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No statistical analyses for this end point |
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End point title |
Maximum recorded reticulocyte count within the first 7 days following admission | ||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
Within first 7 days following admission
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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
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Comparison groups |
Control v Intravenous iron
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Number of subjects included in analysis |
80
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Analysis specification |
Pre-specified
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Analysis type |
equivalence | ||||||||||||
P-value |
= 0.022 | ||||||||||||
Method |
t-test, 2-sided | ||||||||||||
Confidence interval |
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End point title |
Maximum recorded reticulocyte count within the first 7 days following admission | ||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
Within first 7 days following admission
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No statistical analyses for this end point |
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End point title |
Maximum recorded reticulocyte index within the first 7 days following admission | ||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
Within first 7 days following admission
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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
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Comparison groups |
Intravenous iron v Control
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Number of subjects included in analysis |
80
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Analysis specification |
Pre-specified
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Analysis type |
equivalence | ||||||||||||
P-value |
= 0.022 | ||||||||||||
Method |
t-test, 2-sided | ||||||||||||
Confidence interval |
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End point title |
Maximum recorded reticulocyte index within the first 7 days following admission | ||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
Within first 7 days following admission
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No statistical analyses for this end point |
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End point title |
Serum Transferrin Receptor Concentration final day following admission | ||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
Final day
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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
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Comparison groups |
Control v Intravenous iron
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Number of subjects included in analysis |
52
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Analysis specification |
Pre-specified
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Analysis type |
equivalence | ||||||||||||
P-value |
= 0.418 | ||||||||||||
Method |
Chi-squared | ||||||||||||
Confidence interval |
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End point title |
Serum Transferrin Receptor Concentration final day following admission | ||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
Final day
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No statistical analyses for this end point |
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End point title |
Total transfusions during admission | ||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
During admission
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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
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Comparison groups |
Control v Intravenous iron
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Number of subjects included in analysis |
80
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Analysis specification |
Pre-specified
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Analysis type |
equivalence | ||||||||||||
P-value |
= 0.927 | ||||||||||||
Method |
Wilcoxon (Mann-Whitney) | ||||||||||||
Confidence interval |
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End point title |
Total transfusions during admission | ||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
During admission
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No statistical analyses for this end point |
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End point title |
Participants transfused during admission | |||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
During admission
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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
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Comparison groups |
Intravenous iron v Control
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Number of subjects included in analysis |
80
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Analysis specification |
Pre-specified
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Analysis type |
equivalence | |||||||||
P-value |
= 1 | |||||||||
Method |
Chi-squared | |||||||||
Confidence interval |
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End point title |
Total transfusions in first week | ||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
During first week
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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
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Comparison groups |
Intravenous iron v Control
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Number of subjects included in analysis |
80
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Analysis specification |
Pre-specified
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Analysis type |
equivalence | ||||||||||||
P-value |
= 0.899 | ||||||||||||
Method |
Chi-squared | ||||||||||||
Confidence interval |
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End point title |
Total transfusions in first week | ||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
During the first week
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No statistical analyses for this end point |
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End point title |
Participants transfused during first week | |||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
During the first week
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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
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Comparison groups |
Control v Intravenous iron
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Number of subjects included in analysis |
80
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|||||||||
Analysis specification |
Pre-specified
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Analysis type |
equivalence | |||||||||
P-value |
= 1 | |||||||||
Method |
Wilcoxon (Mann-Whitney) | |||||||||
Confidence interval |
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End point title |
Infective complications | |||||||||
End point description |
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End point type |
Secondary
|
|||||||||
End point timeframe |
During length of study
|
|||||||||
|
||||||||||
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 |
|
||||||||||
End point title |
Cardiovascular complications | |||||||||
End point description |
||||||||||
End point type |
Secondary
|
|||||||||
End point timeframe |
During length of study
|
|||||||||
|
||||||||||
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 |
|
|||||||||||||
End point title |
Cumulated ambulation score | ||||||||||||
End point description |
|||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Days 1 to 3
|
||||||||||||
|
|||||||||||||
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 |
|
|||||||||||||
End point title |
Cumulated ambulation score | ||||||||||||
End point description |
|||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Days 1 to 3
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Length of hospital stay | ||||||||||||
End point description |
|||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Duration of the study
|
||||||||||||
|
|||||||||||||
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 |
|
|||||||||||||
End point title |
Length of hospital stay | ||||||||||||
End point description |
|||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Duration of the study
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Length of postoperative hospital stay | ||||||||||||
End point description |
|||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Period remain hospitalised following operation
|
||||||||||||
|
|||||||||||||
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 |
|
|||||||||||||
End point title |
Length of postoperative hospital stay | ||||||||||||
End point description |
|||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Period remain hospitalised following operation
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||||||||||||||
End point title |
Discharge destination | |||||||||||||||||||||||||||
End point description |
||||||||||||||||||||||||||||
End point type |
Secondary
|
|||||||||||||||||||||||||||
End point timeframe |
Discharge from hospital
|
|||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||
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 |
|
||||||||||
End point title |
Mortality at 30-days | |||||||||
End point description |
||||||||||
End point type |
Secondary
|
|||||||||
End point timeframe |
30-days post randomisation
|
|||||||||
|
||||||||||
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 information
|
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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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
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Frequency threshold for reporting non-serious adverse events: 0.05% | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|
|||||||
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 | |||||||
|
|||||||
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 |