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 design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Prevention
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	The principal study outcome measure will be the incidence of PTS in each group.
Secondary outcome measures	Not provided at time of registration
Overall study start date	15/08/2001
Completion date	01/01/2006

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	A total of 100 patients will be randomised by a sealed envelope technique into each group (study total 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

England
United Kingdom

Study participating centre

Addenbrooke's NHS Trust

Cambridge
CB2 2QQ
United Kingdom

Sponsor information

Department of Health (UK)
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website	http://www.doh.gov.uk

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 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