Effects of tranexamic acid in total knee arthroplasty - pilot study
| ISRCTN | ISRCTN43363116 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN43363116 |
| Protocol serial number | N0162147151 |
| Sponsor | Department of Health |
| Funder | Northampton General Hospital NHS Trust (UK), R&D NHS support funding |
- Submission date
- 30/09/2005
- Registration date
- 30/09/2005
- Last edited
- 21/04/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr Christopher Little
Scientific
Scientific
Dept Orthopaedics
Northampton General Hospital NHS Trust
Northampton
NN1 5BD
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | To establish whether tranexamic acid can reduce bleeding after knee replacement surgery without increasing the risk of deep venous thrombosis. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Surgery: Total knee arthroplasty |
| Intervention | Prospective, randomised controlled trial of 15 mg/ kg tranexamic acid v equivalent volume of normal saline given iv prior to tourniquet release during TKA |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | tranexamic acid |
| Primary outcome measure(s) |
1. Blood loss in the first 48 hours post op |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/05/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 30 |
| Key inclusion criteria | 15 patients, 15 control patients of any age who are planned to have total knee arthroplasty |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/11/2000 |
| Date of final enrolment | 31/05/2004 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Dept Orthopaedics
Northampton
NN1 5BD
United Kingdom
NN1 5BD
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/03/2006 | Yes | No |
