Condition category
Surgery
Date applied
05/09/2012
Date assigned
10/09/2012
Last edited
05/11/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Iain Moppett

ORCID ID

Contact details

University of Nottingham
Department of Anaesthesia and Intensive Care
Queens Medical Centre
Nottingham
NG7 2UH
United Kingdom
iain.moppett@nottingham.ac.uk

Additional identifiers

EudraCT number

2011-003233-34

ClinicalTrials.gov number

Protocol/serial number

11206

Study information

Scientific title

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

Acronym

IVANOF1

Study hypothesis

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

Ethics approval

Not provided at time of registration

Study design

Randomised interventional trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Blood, Injuries and Emergencies

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

Phase

Not Applicable

Drug names

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)

Overall trial start date

12/06/2012

Overall trial end date

12/03/2014

Reason abandoned

Eligibility

Participant inclusion criteria

1. Primary hip fracture
2. Aged over 70
3. Able to consent for themselves
4. Male and female participants

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

UK Sample Size: 80

Participant exclusion criteria

1. Undisplaced intracapsular fractures (very low transfusion requirements
2. Contraindications to intravenous iron
3. Currently taking antiplatelet drugs other than aspirin

Recruitment start date

12/06/2012

Recruitment end date

12/03/2014

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Nottingham
Nottingham
NG7 2UH
United Kingdom

Sponsor information

Organisation

University of Nottingham (UK)

Sponsor details

University Park
Nottingham
NG7 2RD
United Kingdom

Sponsor type

University/education

Website

http://www.nottingham.ac.uk/

Funders

Funder type

Research organisation

Funder name

National Institute of Academic Anaesthesia [NIAA] (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2013 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/24015990

Publication citations

  1. Protocol

    Rowlands M, Forward DP, Sahota O, Moppett IK, The effect of intravenous iron on postoperative transfusion requirements in hip fracture patients: study protocol for a randomized controlled trial., Trials, 2013, 14, 288, doi: 10.1186/1745-6215-14-288.

Additional files

Editorial Notes