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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list
2013 results in https://www.ncbi.nlm.nih.gov/pubmed/23756263