Fibrin sealant to reduce blood loss after hip replacement
| ISRCTN | ISRCTN10862406 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10862406 |
| Protocol serial number | N0234117607 |
| Sponsor | Department of Health (UK) |
| Funder | North Bristol NHS Trust (UK) |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 14/04/2015
- 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 DKA Smart
Scientific
Scientific
Department of Orthopaedics (AOC)
North Bristol NHS Trust
Southmead Hospital
Westbury-on-Trym
Bristol
BS10 5NB
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | Fibrin sealant to reduce blood loss after hip replacement |
| Study objectives | Does fibrin sealant reduce blood loss after primary and revision hip replacement? |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Surgery: Hip replacement |
| Intervention | Two groups: Revision total hip replacement and Primary total hip replacement. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) |
Quantitative estimate of per-operative blood loss, measurement of post-operative blood loss volume via drains, post-operative haemaglobin level, number of patients requiring blood transfusion. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/07/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 90 |
| Key inclusion criteria | Primary hip replacement: 60 patients not on anticoagulant medications, without blood autoantibodies and with pre-operation Hb level >12.5 will be randomised into treatment and control groups. Revision hip replacement: 30 consecutive patients in treatment group not randomized. Control group will be historical, with information regarding blood loss gained from a retrospective review of notes. |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/08/2002 |
| Date of final enrolment | 31/07/2003 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
North Bristol NHS Trust
Bristol
BS10 5NB
United Kingdom
BS10 5NB
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 |
