|
ISRCTN
|
ISRCTN11165766
|
|
ClinicalTrials.gov identifier
|
|
|
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
|
|
Serial number at source
|
N0557093705
|
|
Study hypothesis
|
How long does it take for the bleeding time to return to normal after stopping aspirin?
|
|
Ethics approval
|
Not provided at time of registration
|
|
Study design
|
Randomised double blind placebo controlled trial.
|
|
Countries of recruitment
|
United Kingdom
|
|
Disease/condition/study domain
|
Haemostasis
|
|
Participants - inclusion criteria
|
100 Patients undergoing orthopaedic surgery.
|
|
Participants - exclusion criteria
|
Does not meet inclusion criteria
|
|
Anticipated start date
|
01/10/2000
|
|
Anticipated end date
|
31/10/2004
|
|
Status of trial
|
Completed |
|
Patient information material
|
|
|
Target number of participants
|
100
|
|
Interventions
|
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
|
|
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 (UK)
|
|
Trial website
|
|
|
Publications
|
|
|
Contact name
|
Dr
Julian
Sonksen
|
|
Address
|
Department of Anaesthetics
Russells Hall Hospital
|
|
City/town
|
Dudley
|
|
Zip/Postcode
|
DY1 2HQ
|
|
Country
|
United Kingdom
|
|
Sponsor
|
Record provided by the NHS Trusts Clinical Trials Register - Department of Health (UK)
|
|
Address
|
The Department of Health
Richmond House
79 Whitehall
|
|
City/town
|
London
|
|
Zip/Postcode
|
SW1A 2NL
|
|
Country
|
United Kingdom
|
|
Tel
|
+44 (0)20 7307 2622
|
|
Fax
|
+44 (0)20 7307 2623
|
|
Email
|
dhmail@doh.gsi.org.uk
|
|
Sponsor website:
|
http://www.doh.gov.uk
|
|
Date applied
|
12/09/2003
|
|
Last edited
|
10/07/2009
|
|
Date ISRCTN assigned
|
12/09/2003
|