Blood transfusion in lower limb arthroplasty: the safe and economical future
| ISRCTN | ISRCTN24531848 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN24531848 |
| Protocol serial number | N0155119586 |
| Sponsor | Department of Health (UK) |
| Funder | North Manchester Healthcare NHS Trust (UK) |
- 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
Scientific
Department of Orthopaedics
North Manchester General Hospital
Delaunays Road
Crumpsall
Manchester
M8 5RB
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | Blood transfusion in lower limb arthroplasty: the safe and economical future |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/12/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 120 |
| Key inclusion criteria | 120 patients undergoing primary knee arthroplasty |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/01/2003 |
| Date of final enrolment | 01/12/2004 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
North Manchester General Hospital
Manchester
M8 5RB
United Kingdom
M8 5RB
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
