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The effect of intravenous iron on postoperative transfusion requirements in... | Not Recruiting
The effect of intravenous iron on p... | Not Recruiting
The effect of intravenous iron on postoperative transfusion requirements in hip fracture patients - the IVANOF1 Study
IVANOF1

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Medical Conditions
  • Blood, Injuries and Emergencies
Primary Contact Details
Recruitment Status
Not Recruiting
Trial source and source ID number
ISRCTN76424792
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Summary
Not provided at time of registration
Research Details
  • Anaemia following hip fracture is common. Approximately 30-45 % of patients have haemoglobin concentrations ([Hb]) below population norms on admission and around 10% are severely anaemic. Anaemia on admission and in the postoperative period is associated with poor outcome with regard to mobility, postoperative mortality and readmission. There is currently no clear consensus on the optimal method to manage peri-operative anaemia in this frail group of patients with frequent comorbidity. Liberal red cell transfusion in the postoperative period does not appear to improve outcome and tranexamic acid appears to reduce transfusion rate at the expense of increased cardiovascular morbidity. There are encouraging results from one centre with the use of agents to stimulate red cell production, including intravenous iron and erythropoietin. UK practice has significant differences to the patients and these studies and it is not clear whether these promising results will translate to the UK population.

    More details can be found at http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=11206
Phase
Not Applicable
Study Design
Randomised interventional trial
Study Type
Interventional
Intervention

Single-centre randomised controlled parallel group trial. Randomisation by website using computer generated concealed tables. Setting: University hospital in UK. Participants: 80 patients with acute hip fracture undergoing operative repair and aged > 70 years.

Intervention: Three daily infusions of 200mg iron sucrose starting within 24 hours of admission. Control group: standard hospital care at the discretion of the clinical team. Red cell transfusions for each group are given in accordance with standard clinical triggers.

Primary outcome: difference in mean reticulocyte count between groups at day 7.
Secondary outcomes include: haemoglobin concentrations, early and late transfusion rates, infectious and cardiovascular complications, mobility and 30-day mortality.

Intervention Type
Procedure/Surgery
Primary Outcome Measures
    Reticulocyte count measured at day 7
Secondary Outcome Measures
    1. Infective complications
    2. Length of actue hospital stay
    3. Minimum haemoglobin
    4. Mortality within first 7 days
    5. Mortality within first 30 days
    5. Safety variables
    6. Transfusion requirements
    7. Pre-operative transfusion
    8. Postoperative transfusion
    9. Late transfusion (> day 7)
Publication(s)
2013 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/24015990
Result Reports
See additional file (ISRCTN76424792_BasicResults_15Nov18.pdf)
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Gender
Both
Age Range
Senior
Who Can Participate
Patient
Number of Participants
UK Sample Size: 80
Participant Inclusion Criteria
    1. Primary hip fracture
    2. Aged over 70
    3. Able to consent for themselves
    4. Male and female participants
Participant Exclusion Criteria
    1. Undisplaced intracapsular fractures (very low transfusion requirements
    2. Contraindications to intravenous iron
    3. Currently taking antiplatelet drugs other than aspirin
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
Nottingham
NG7 2UH
Trial Contact(s)
Primary Trial Contact
Dr Iain Moppett
-
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
United Kingdom
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Scientific Title
The effect of intravenous iron on postoperative transfusion requirements in hip fracture patients – a pilot study
EudraCT Number
2011-003233-34
Funder(s)
  • National Institute of Academic Anaesthesia [NIAA] (UK)
Other Study ID Numbers
11206
Sponsor(s)
University of Nottingham (UK)
Key Dates

Recruitment Start Date

12 Jun 2012

Recruitment End Date

12 Mar 2014

Trial Start Date

12 Jun 2012

Trial End Date

12 Mar 2014

Date added to source

10 Sep 2012

Date updated in source

15 Nov 2018