Randomised trial of a blood transfusion policy after fracture of the proximal femur (hip fracture)

ISRCTN ISRCTN61328173
DOI https://doi.org/10.1186/ISRCTN61328173
Secondary identifying numbers N0181115109
Submission date
12/09/2003
Registration date
12/09/2003
Last edited
04/10/2017
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr Martyn Parker
Scientific

Orthopaedic Department
Peterborough Hospitals NHS Trust
Peterborough District Hospital
Thorpe Road
Peterborough
PE3 6DA
United Kingdom

Email martyn.parker@pbh-tr.nhs.uk

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific titleRandomised trial of a blood transfusion policy after fracture of the proximal femur (hip fracture)
Study objectivesThe threshold at which blood transfusion should be given after surgery is the subject of controversy. This study aims to address this question of transfusion after hip fracture surgery.
Ethics approval(s)Peterborough and Fenland LREC, ref: PO1/154
Health condition(s) or problem(s) studiedSurgery: Blood transfusion
InterventionPatients are then randomised (if willing) to either no transfusion and to receive oral iron supplements or have a blood transfusion to raise the haemaglobin above 10 g/dl.
Intervention typeProcedure/Surgery
Primary outcome measureMortality
Secondary outcome measuresLength of hospital stay, complications
Overall study start date01/08/2002
Completion date01/05/2012

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participantsNot provided at time of registration
Key inclusion criteriaHaemaglobin between 8 to 9.5 g/dl after hip fracture surgery.
Key exclusion criteria1. Patients unwilling to give written informed consent
2. Post-operative haemoglobin on day 1 or 2 after surgery of below 8g/dl or above 10g/dl
3. Multiple trauma. (defined as either more than two other fractures or any other fracture requiring surgery other than simple manipulation alone)
4. Patients who refuse transfusion due to religious reasons
5. Patients aged less than 60 years
Date of first enrolment01/08/2002
Date of final enrolment01/05/2012

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Peterborough District Hospital
Peterborough
PE3 6DA
United Kingdom

Sponsor information

Department of Health (UK)
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website http://www.doh.gov.uk

Funders

Funder type

Government

Peterborough Hospitals NHS Trust (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/12/2013 Yes No

Editorial Notes

04/10/2017: Publication reference added.