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

ISRCTN	ISRCTN61328173
DOI	https://doi.org/10.1186/ISRCTN61328173
Protocol serial number	N0181115109
Sponsor	Department of Health (UK)
Funder	Peterborough Hospitals NHS Trust (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
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(s)	Mortality
Key secondary outcome measure(s)	Length of hospital stay, complications
Completion date	01/05/2012

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
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

Peterborough District Hospital

Peterborough
PE3 6DA
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

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

04/10/2017: Publication reference added.