| Source of record | UK Trials |
| ISRCTN | ISRCTN11165766 |
| Date ISRCTN assigned | 12/09/2003 |
| Local reference number(s) | N0557093705 |
| Public title | The influence of low dose aspirin therapy on perioperative primary haemostasis in patients with vascular disease undergoing orthopaedic surgery |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Haematological Disorders: Haemostasis |
| Study hypothesis | How long does it take for the bleeding time to return to normal after stopping aspirin? |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | 100 Patients undergoing orthopaedic surgery. |
| Participants - exclusion criteria | Not provided at time of registration |
| Patient information material |
|
| Anticipated start date | 01/10/2000 |
| Anticipated end date | 31/10/2004 |
| Status of trial | Completed |
| Target number of participants | 100 |
| Interventions | Randomised double blind, placebo controlled trial. Each patient receives three containers of tablets (5+3+2) containing either aspirin or placebo. Random allocation to:
A. 10 days aspirin
B. 8 days aspirin + 2 days placebo
C. 5 days aspirin + 5 days placebo
D. 10 days placebo |
| Primary outcome measure(s) | Bleeding times on day of recruitment, morning of surgery and after surgery. |
| Secondary outcome measure(s) | Not provided at time of registration |
| Sources of funding | The Dudley Group of Hospitals NHS Trust |
| Sponsor name | Record provided by the NHS Trusts Clinical Trials Register - Department of Health (UK) |
| Sponsor details | The Department of Health
Richmond House
79 Whitehall
London
United Kingdom
SW1A 2NL |
| Sponsor telephone | +44 (0)20 7307 2622 |
| Sponsor fax | +44 (0)20 7307 2623 |
| Sponsor email | dhmail@doh.gsi.org.uk |
| Sponsor website | http://www.doh.gov.uk |
| Contact name | Dr Julian Sonksen |
| Contact details | Department of Anaesthetics
Russells Hall Hospital
Dudley
United Kingdom
DY1 2HQ |
| Contact telephone | +44 01384 244076 |
| Contact fax | +44 01384 244044 |
| Contact email | j.sonksen@btinternet.com |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN11165766 |
| Date last extracted from ISRCTN register | 17/04/2008 |
