Condition category
Circulatory System
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
18/04/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr David Fitzmaurice

ORCID ID

Contact details

Department of General Practice
The Medical School
University of Birmingham
Edgbaston
Birmingham
B15 2TT
United Kingdom
+44 (0)121 414 3760
D.A.Fitzmaurice@bham.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

RGC00325

Study information

Scientific title

Acronym

Study hypothesis

Not provided at time of registration

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Not Specified

Patient information sheet

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

Condition

Cardiovascular diseases: Thromboembolic disease

Intervention

1. Intervention patients will either be discharged from A&E following confirmation of diagnosis having been given the first dose of low-molecular weight heparin (LMWH) and warfarin, or prior to confirmation of diagnosis having received only the first dose of LMWH. Patients requiring confirmation of diagnosis will be recalled for special clinics established for the study.
2. Control patients will be managed according to the hospital protocol. This normally requires admission for confirmation of diagnosis and commencement of formal anticoagulation with intra-venous heparin. The confirmatory investigation in all cases will be ultrasound.
All patients with positive diagnosis of DVT will be recalled 4 weeks after the initial ultrasound for repeat investigation to determine the resolution of the clot and to complete a Quality of Life questionnaire.

As of 18/04/2012, this study was stopped due to poor recruitment in 1999.

Intervention type

Drug

Phase

Not Specified

Drug names

heparin

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/01/2000

Overall trial end date

31/12/2000

Reason abandoned

Participant recruitment issue

Eligibility

Participant inclusion criteria

All patients aged 18 or over presenting to the A&E Department of the City Hospital, Birmingham, with a clinical diagnosis of Deep Venous Thrombosis (DVT) will be eligible for entry into the study. Patients will be randomised to either an intervention or control arm of the study. 484 patients will be recruited. Assuming a radiological positive diagnosis rate of 50% this will leave 121 patients in each arm of the study.

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

484

Participant exclusion criteria

Patients who need to be admitted to hospital for concomitant reasons, patients requiring venography, pregnant and breast feeding women and patients with concurrent malignancy will be excluded.

Recruitment start date

01/01/2000

Recruitment end date

31/12/2000

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of General Practice
Birmingham
B15 2TT
United Kingdom

Sponsor information

Organisation

NHS R&D Regional Programme Register - Department of Health (UK)

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

NHS Executive West Midlands (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

Publication citations

Additional files

Editorial Notes