Blood transfusion in lower limb arthroplasty: the safe and economical future

ISRCTN ISRCTN24531848
DOI https://doi.org/10.1186/ISRCTN24531848
Secondary identifying numbers N0155119586
Submission date
12/09/2003
Registration date
12/09/2003
Last edited
28/11/2014
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr DH Sochart
Scientific

Department of Orthopaedics
North Manchester General Hospital
Delaunays Road
Crumpsall
Manchester
M8 5RB
United Kingdom

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific titleBlood transfusion in lower limb arthroplasty: the safe and economical future
Study objectivesProspective 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(s)Not provided at time of registration
Health condition(s) or problem(s) studiedSurgery: Primary knee arthroplasty
Intervention1. Group A (60) will receive homologous transfusion
2. Group B (60) will receive wound drained autotransfusion
Intervention typeProcedure/Surgery
Primary outcome measureNot provided at time of registration
Secondary outcome measuresNot provided at time of registration
Overall study start date01/01/2003
Completion date01/12/2004

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participants120
Key inclusion criteria120 patients undergoing primary knee arthroplasty
Key exclusion criteriaNot provided at time of registration
Date of first enrolment01/01/2003
Date of final enrolment01/12/2004

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

North Manchester General Hospital
Manchester
M8 5RB
United Kingdom

Sponsor information

Department of Health (UK)
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website http://www.doh.gov.uk

Funders

Funder type

Government

North Manchester Healthcare NHS Trust (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan