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    Clinical Trial Results:
    Is intravenous iron and darbepoetin more effective than oral iron in reducing blood transfusion requirements for patients undergoing cardiac surgery

    Summary
    EudraCT number
    2011-003695-36
    Trial protocol
    GB  
    Global end of trial date
    11 Nov 2019

    Results information
    Results version number
    v1(current)
    This version publication date
    31 Jan 2020
    First version publication date
    31 Jan 2020
    Other versions
    Summary report(s)
    INITIATE Clinical study summary report

    Trial information

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    Trial identification
    Sponsor protocol code
    11/LO/1310
    Additional study identifiers
    ISRCTN number
    ISRCTN41421863
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Brighton and Sussex University Hospitals Trust
    Sponsor organisation address
    Royal Sussex County Hospital Eastern Road, Brighton, United Kingdom, BN2 5BE
    Public contact
    Mr Scott Harfield, Brighton and Sussex University Hospitals, 044 01273 696955, Scott.Harfield@bsuh.nhs.uk
    Scientific contact
    Mr Scott Harfield, Brighton and Sussex University Hospitals, 044 01273 696955, Scott.Harfield@bsuh.nhs.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
    11 Nov 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    11 Nov 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    11 Nov 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    In patients who have a low haemoglobin level before surgery, will treatment using a combination of intravenous iron and darbepoetin result in less blood transfusion after heart surgery than treatment using iron tablets alone.
    Protection of trial subjects
    Patients were given full advice and information through the participation information sheet before being asked if they wished to participate in the study and once involved they were asked at each visit whether they wished to continue and were free to withdraw from the study. After treatment the patients were monitored to ensure they were in no distress and all was well before being told that they were free to return home. They were given the contact numbers of the research staff in case they had any queries and also the contact details of the Patient Advice and Liaison Service
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    02 Apr 2012
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 170
    Worldwide total number of subjects
    170
    EEA total number of subjects
    170
    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)
    170
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    Intervention group analysed: 79 Standard care group analysed: 77 Total randomised: 170

    Pre-assignment
    Screening details
    2799 patients undergoing elective cardiac surgery at the centre were screened for eligibility. An Hb concentration between 100 and 130 g/L (inclusive) was required for inclusion

    Period 1
    Period 1 title
    Overall Trial (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Intervention
    Arm description
    Participants in the intervention group received a total dose infusion of iron (III) isomaltoside 1000 (Monofer®). The dose of 1000mg (or 20mg/kg if body weight less than 50kg) was infused
    Arm type
    Experimental

    Investigational medicinal product name
    iron (III) isomaltoside 1000 (Monofer®).
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous drip use
    Dosage and administration details
    Participants in the intervention group received a total dose infusion of iron (III) isomaltoside 1000 (Monofer®). The dose of 1000mg (or 20mg/kg if body weight less than 50kg) was infused according to the manufacturer’s recommended protocol via a peripheral vein

    Arm title
    Standard of care
    Arm description
    Participants randomised to Standard Care were instructed to see their GP as soon as possible. The participant was given a prescription for 2 week supply of ferrous sulphate and prescribed the maximum tolerated dose of oral ferrous sulphate (starting at 200mg x 3 per day) until the day of surgery. Participants who do not tolerate this dose will be asked to reduce the dose to 200mg x2 or 200mg x1 per day. Concurrent deficiencies in vitamin B12 or folate or abnormal thyroid function will be treated according to standard practice.
    Arm type
    Active comparator

    Investigational medicinal product name
    ferrous sulphate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants randomised to Standard Care were instructed to see their GP as soon as possible. The participant was given a prescription for 2 week supply of ferrous sulphate and prescribed the maximum tolerated dose of oral ferrous sulphate (starting at 200mg x 3 per day) until the day of surgery. Participants who do not tolerate this dose will be asked to reduce the dose to 200mg x2 or 200mg x1 per day. Concurrent deficiencies in vitamin B12 or folate or abnormal thyroid function will be treated according to standard practice.

    Number of subjects in period 1
    Intervention Standard of care
    Started
    86
    84
    Completed
    79
    77
    Not completed
    7
    7
         Physician decision
    7
    7

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall Trial
    Reporting group description
    -

    Reporting group values
    Overall Trial Total
    Number of subjects
    170 170
    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
    Units: years
        arithmetic mean (inter-quartile range (Q1-Q3))
    74 (68 to 79) -
    Gender categorical
    Units: Subjects
        Female
    85 85
        Male
    85 85

    End points

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    End points reporting groups
    Reporting group title
    Intervention
    Reporting group description
    Participants in the intervention group received a total dose infusion of iron (III) isomaltoside 1000 (Monofer®). The dose of 1000mg (or 20mg/kg if body weight less than 50kg) was infused

    Reporting group title
    Standard of care
    Reporting group description
    Participants randomised to Standard Care were instructed to see their GP as soon as possible. The participant was given a prescription for 2 week supply of ferrous sulphate and prescribed the maximum tolerated dose of oral ferrous sulphate (starting at 200mg x 3 per day) until the day of surgery. Participants who do not tolerate this dose will be asked to reduce the dose to 200mg x2 or 200mg x1 per day. Concurrent deficiencies in vitamin B12 or folate or abnormal thyroid function will be treated according to standard practice.

    Primary: Did participant receive one red cell transfusion on days 0-5

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    End point title
    Did participant receive one red cell transfusion on days 0-5 [1]
    End point description
    End point type
    Primary
    End point timeframe
    0-5 days post surgery
    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: See attached documents for results
    End point values
    Intervention Standard of care
    Number of subjects analysed
    53
    63
    Units: Yes or No
    53
    63
    Attachments
    INITIATE Analysis
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    For the duration of the study
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    18
    Frequency threshold for reporting non-serious adverse events: 0%
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: See attached documents for adverse events

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    20 Mar 2013
    Addition to, and clarification of, the exclusion criteria and stipulation of SAE reporting process
    06 Sep 2013
    1. Clarification that a change in Hb count prior to randomisation will not necessarily result in the participant becoming ineligible for the study. 2. Indicating that the intravenous iron infusions may be done in CIRU. 3. Clarifying that the end of study visit may not necessarily be 6-weeks after surgery, but whenever the post-operative outpatient appointment takes place. 4. Amending the AE and SAE reporting to suggest that all AEs will only require recording for trial purposes between IMP administration and surgery, and not post-surgery. SAEs and recognised complications during and after surgery should not be recorded if listed as expected in table 14.3. 5. Updating Hb measurement to the new guidelines (g/l instead of g/dl)
    29 Sep 2016
    Allowance for interim analysis

    Interruptions (globally)

    Were there any global interruptions to the trial? No

    Limitations and caveats

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