Effects of tranexamic acid in total knee arthroplasty - pilot study
| ISRCTN | ISRCTN43363116 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN43363116 |
| Secondary identifying numbers | N0162147151 |
- 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
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | tranexamic acid |
| Primary outcome measure | 1. Blood loss in the first 48 hours post op 2. Transfusion requirements 3. Screen-detected DVT |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/11/2000 |
| Completion date | 31/05/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 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
- England
- United Kingdom
Study participating centre
Dept Orthopaedics
Northampton
NN1 5BD
United Kingdom
NN1 5BD
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Government
Northampton General Hospital NHS Trust (UK), R&D NHS support funding
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
