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
Scientific
Orthopaedic Department
Peterborough Hospitals NHS Trust
Peterborough District Hospital
Thorpe Road
Peterborough
PE3 6DA
United Kingdom
| martyn.parker@pbh-tr.nhs.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | Randomised trial of a blood transfusion policy after fracture of the proximal femur (hip fracture) |
| Study objectives | The 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) studied | Surgery: Blood transfusion |
| Intervention | Patients 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 type | Procedure/Surgery |
| Primary outcome measure | Mortality |
| Secondary outcome measures | Length of hospital stay, complications |
| Overall study start date | 01/08/2002 |
| Completion date | 01/05/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | Not provided at time of registration |
| Key inclusion criteria | Haemaglobin between 8 to 9.5 g/dl after hip fracture surgery. |
| Key exclusion criteria | 1. 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 enrolment | 01/08/2002 |
| Date of final enrolment | 01/05/2012 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Peterborough District Hospital
Peterborough
PE3 6DA
United Kingdom
PE3 6DA
United Kingdom
Sponsor information
Department of Health (UK)
Government
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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not 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.
