An investigation into the role of compression stockings in the prevention of post-thrombotic syndrome
| ISRCTN | ISRCTN20380419 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN20380419 |
| Protocol serial number | N0544116504 |
| Sponsor | Department of Health (UK) |
| Funder | Cambridge Consortium - Addenbrooke's (UK) |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 28/11/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- 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
Mr Kevin Varty
Scientific
Scientific
Box 201
Department of Surgery
Addenbrooke's NHS Trust
Cambridge
CB2 2QQ
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | An investigation into the role of compression stockings in the prevention of post-thrombotic syndrome |
| Study objectives | Do symptom-free patients 6 months after acute deep vein thrombosis (DVT) need to continue with their support stockings? |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Cardiovascular: Deep vein thrombosis (DVT) |
| Intervention | 1. Continued use of compression stocking 2. No further use of compression stocking Following a deep vein thrombosis (DVT) in the leg, patients are anticoagulated and fitted with a class 2 below knee graduated compression stocking. The latter has been shown to reduce the incidence of painful leg swelling, skin changes and the risk of ulceration arising due to damage to the venous system in the leg. This is referred to as the Post Thrombotic Syndrome (PTS). In the only randomised study to assess this, stockings were worn for a minimum of 2 years and the incidence of PTS halved. In routine daily practice however, patients with few symptoms at 6 months are reluctant to continue with stockings. We are uncertain clinically whether the continued use of stockings in these patients is essential or beneficial. In this study we will randomise patients 6 months after DVT with no or few symptoms in the leg to either continued use of the stocking for a further 18 months, or no stocking. Both groups will be followed on a 6 monthly basis and a clinical assessment of PTS, and stocking compliance will be made at each visit. A venous ultrasound scan will be carried out at entry into the study and at 18 months. From this an objective venous segmental disease score will be recorded. |
| Intervention type | Other |
| Primary outcome measure(s) |
The principal study outcome measure will be the incidence of PTS in each group. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/01/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 200 |
| Key inclusion criteria | Not provided at time of registration |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 15/08/2001 |
| Date of final enrolment | 01/01/2006 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Addenbrooke's NHS Trust
Cambridge
CB2 2QQ
United Kingdom
CB2 2QQ
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 |
