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 |
| Protocol serial number | RGC00325 |
| Sponsor | NHS R&D Regional Programme Register - Department of Health (UK) |
| Funder | NHS Executive West Midlands (UK) |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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 |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | heparin |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| 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 sample size at registration | 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
- United Kingdom
- England
Study participating centre
Department of General Practice
Birmingham
B15 2TT
United Kingdom
B15 2TT
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
