An investigation into the role of compression stockings in the prevention of post-thrombotic syndrome

ISRCTN ISRCTN20380419
DOI https://doi.org/10.1186/ISRCTN20380419
Secondary identifying numbers N0544116504
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

Box 201
Department of Surgery
Addenbrooke's NHS Trust
Cambridge
CB2 2QQ
United Kingdom

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typePrevention
Scientific titleAn investigation into the role of compression stockings in the prevention of post-thrombotic syndrome
Study objectivesDo 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) studiedCardiovascular: Deep vein thrombosis (DVT)
Intervention1. 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 typeOther
Primary outcome measureThe principal study outcome measure will be the incidence of PTS in each group.
Secondary outcome measuresNot provided at time of registration
Overall study start date15/08/2001
Completion date01/01/2006

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participantsA total of 100 patients will be randomised by a sealed envelope technique into each group (study total 200).
Key inclusion criteriaNot provided at time of registration
Key exclusion criteriaNot provided at time of registration
Date of first enrolment15/08/2001
Date of final enrolment01/01/2006

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Addenbrooke's NHS Trust
Cambridge
CB2 2QQ
United Kingdom

Sponsor information

Funders

Funder type

Government

Cambridge Consortium - Addenbrooke's (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan
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