Prospective comparison of two carbon valve prostheses
| ISRCTN | ISRCTN72276012 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN72276012 |
| Secondary identifying numbers | N0264073738 |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 05/10/2009
- 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
Dr Alan Bryan
Scientific
Scientific
c/o Research and Development Office
Level 1, Old Building
Bristol Royal Infirmary
Marlborough Street
Bristol
BS2 8HW
United Kingdom
| Phone | +44 (0)117 928 3473 |
|---|
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study objectives | Comparison of long-term clinical outcome with two bileaflet carbon prostheses. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Surgery: Mechanical heart valve replacement |
| Intervention | Randomised prospective trial. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | 1. Death 2. Thromboembolic events 3. Bleeding 4. Valve dysfunction. |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/07/1993 |
| Completion date | 01/02/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 485 |
| Key inclusion criteria | Patients undergoing mechanical heart valve replacement. |
| Key exclusion criteria | Does not meet inclusion criteria |
| Date of first enrolment | 01/07/1993 |
| Date of final enrolment | 01/02/2005 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
c/o Research and Development Office
Bristol
BS2 8HW
United Kingdom
BS2 8HW
United Kingdom
Sponsor information
Department of Health (UK)
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.doh.gov.uk |
|---|
Funders
Funder type
Government
United Bristol Healthcare NHS Trust (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 | 01/01/2002 | Yes | No | |
| Results article | results | 01/03/2007 | Yes | No |
