Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0155119586
Study information
Scientific title
Blood transfusion in lower limb arthroplasty: the safe and economical future
Acronym
Study hypothesis
Prospective randomised study comparing the effect of homologous blood transfusion and autotransfusion of shed blood in 120 patients undergoing primary total knee replacement on the incidence of post-operative bacterial infection, immune modulation, complement and leukocyte activation and changes in coagulation and fibrinolysis following transfusion.
Ethics approval
Not provided at time of registration
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: Primary knee arthroplasty
Intervention
1. Group A (60) will receive homologous transfusion
2. Group B (60) will receive wound drained autotransfusion
Intervention type
Procedure/Surgery
Phase
Not Specified
Drug names
Primary outcome measures
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/01/2003
Overall trial end date
01/12/2004
Reason abandoned
Eligibility
Participant inclusion criteria
120 patients undergoing primary knee arthroplasty
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
120
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/01/2003
Recruitment end date
01/12/2004
Locations
Countries of recruitment
United Kingdom
Trial participating centre
North Manchester General Hospital
Manchester
M8 5RB
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
North Manchester Healthcare 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