Condition category
Surgery
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
11/06/2015
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

Mr Martyn Parker

ORCID ID

Contact details

Orthopaedic Department
Peterborough Hospitals NHS Trust
Peterborough District Hospital
Thorpe Road
Peterborough
PE3 6DA
United Kingdom
-
martyn.parker@pbh-tr.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0181115109

Study information

Scientific title

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

Acronym

Study hypothesis

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

Peterborough and Fenland LREC, ref: PO1/154

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

Mortality

Secondary outcome measures

Length of hospital stay, complications

Overall trial start date

01/08/2002

Overall trial end date

01/05/2012

Reason abandoned

Eligibility

Participant inclusion criteria

Haemaglobin between 8 to 9.5 g/dl after hip fracture surgery.

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

Not provided at time of registration

Participant 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

Recruitment start date

01/08/2002

Recruitment end date

01/05/2012

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Peterborough District Hospital
Peterborough
PE3 6DA
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

Peterborough Hospitals NHS Trust (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

Publication citations

Additional files

Editorial Notes