The influence of low dose aspirin therapy on perioperative primary haemostasis in patients with vascular disease undergoing orthopaedic surgery
| ISRCTN | ISRCTN11165766 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11165766 |
| Protocol serial number | N0557093705 |
| Sponsor | Department of Health (UK) |
| Funder | The Dudley Group of Hospitals NHS Trust (UK) |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 02/05/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Haematological Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Julian Sonksen
Scientific
Scientific
Department of Anaesthetics
Russells Hall Hospital
Dudley
DY1 2HQ
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised double blind placebo controlled trial. |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | |
| Study objectives | How long does it take for the bleeding time to return to normal after stopping aspirin? |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Haemostasis |
| Intervention | Each patient receives three containers of tablets (5+3+2) containing either aspirin or placebo. Random allocation to: 1. 10 days aspirin 2. 8 days aspirin + 2 days placebo 3. 5 days aspirin + 5 days placebo 4. 10 days placebo |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | aspirin |
| Primary outcome measure(s) |
Bleeding times on day of recruitment, morning of surgery and after surgery. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/10/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 100 |
| Key inclusion criteria | 100 Patients undergoing orthopaedic surgery. |
| Key exclusion criteria | Does not meet inclusion criteria |
| Date of first enrolment | 01/10/2000 |
| Date of final enrolment | 31/10/2004 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Department of Anaesthetics
Dudley
DY1 2HQ
United Kingdom
DY1 2HQ
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 | 01/03/1999 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
