Randomised controlled trial (RCT) of community management of deep venous thrombosis (DVT) using low molecular weight heparin versus hospital care
| ISRCTN | ISRCTN25452470 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN25452470 |
| Secondary identifying numbers | RGC00325 |
- Submission date
- 23/01/2004
- Registration date
- 23/01/2004
- Last edited
- 18/04/2012
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr David Fitzmaurice
Scientific
Scientific
Department of General Practice
The Medical School
University of Birmingham
Edgbaston
Birmingham
B15 2TT
United Kingdom
| Phone | +44 (0)121 414 3760 |
|---|---|
| D.A.Fitzmaurice@bham.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Not Specified |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | |
| Study objectives | Not provided at time of registration |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | heparin |
| Primary outcome measure | Not provided at time of registration |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/01/2000 |
| Completion date | 31/12/2000 |
| Reason abandoned (if study stopped) | Participant recruitment issue |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Not Specified |
| Target number of participants | 484 |
| Key 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. |
| Key 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. |
| Date of first enrolment | 01/01/2000 |
| Date of final enrolment | 31/12/2000 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Department of General Practice
Birmingham
B15 2TT
United Kingdom
B15 2TT
United Kingdom
Sponsor information
NHS R&D Regional Programme Register - Department of Health (UK)
Government
Government
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.doh.gov.uk |
Funders
Funder type
Government
NHS Executive West Midlands (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
