Condition category
Haematological Disorders
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
02/05/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Julian Sonksen

ORCID ID

Contact details

Department of Anaesthetics
Russells Hall Hospital
Dudley
DY1 2HQ
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0557093705

Study information

Scientific title

Acronym

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.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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 names

aspirin

Primary outcome measures

Bleeding times on day of recruitment, morning of surgery and after surgery.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/10/2000

Overall trial end date

31/10/2004

Reason abandoned

Eligibility

Participant inclusion criteria

100 Patients undergoing orthopaedic surgery.

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

100

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

01/10/2000

Recruitment end date

31/10/2004

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Anaesthetics
Dudley
DY1 2HQ
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Hospital/treatment centre

Funder name

The Dudley Group of Hospitals NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 1999 results in http://www.ncbi.nlm.nih.gov/pubmed/10434816

Publication citations

  1. Results

    Sonksen JR, Kong KL, Holder R, Magnitude and time course of impaired primary haemostasis after stopping chronic low and medium dose aspirin in healthy volunteers., Br J Anaesth, 1999, 82, 3, 360-365.

Additional files

Editorial Notes