A randomised controlled trial of the use of topical application of tranexamic acid in primary cemented total hip replacement
| ISRCTN | ISRCTN58762744 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN58762744 |
| Secondary identifying numbers | N0155164510 |
- Submission date
- 29/09/2006
- Registration date
- 29/09/2006
- Last edited
- 22/09/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr Sattar Alshryda
Scientific
Scientific
Dept of Orthopaedics
Fairfield General Hospital
Bury
BL9 7TD
United Kingdom
| Phone | +44 (0) 77950 78485 |
|---|---|
| Sattar26@hotmail.com |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | |
| Study objectives | Can we reduce blood loss associated with total hip replacement by using topical tranexamic acid? |
| Ethics approval(s) | North West MREC Greater Manchester Strategic Health Authority, ref 05/MRE08/10, favourable ethical opinion on 11/04/2005, extended 02/02/2006 |
| Health condition(s) or problem(s) studied | Musculoskeletal Diseases: total hip replacement |
| Intervention | Randomised controlled trial |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Tranexamic acid |
| Primary outcome measure | Reduction in blood loss |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/06/2005 |
| Completion date | 31/12/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 124 |
| Key inclusion criteria | Patients having unilateral primary cemented total hip replacement |
| Key exclusion criteria | 1. Allergic to tranexamic acid 2. Pregnancy 3. History of DVT/pulmonary embolus 4. Patients involved in other trials 5. Known bleeding problems 6. Concurrent treatment with warfarin 7. Low dose molecular weight heparin or conventional heparin 8. Paget's disease or revision total hip replacement |
| Date of first enrolment | 01/06/2005 |
| Date of final enrolment | 31/12/2006 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Dept of Orthopaedics
Bury
BL9 7TD
United Kingdom
BL9 7TD
United Kingdom
Sponsor information
Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Government
Government
The Department of Health
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
Pennine Acute Hospitals NHS Trust (UK)
No information available
NHS R&D Support Funding (UK)
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 | 06/11/2013 | Yes | No |
