Condition category
Circulatory System
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
28/11/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Kevin Varty

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0544116504

Study information

Scientific title

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

Acronym

Study hypothesis

Do symptom-free patients 6 months after acute deep vein thrombosis (DVT) need to continue with their support stockings?

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Prevention

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

The principal study outcome measure will be the incidence of PTS in each group.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

15/08/2001

Overall trial end date

01/01/2006

Reason abandoned

Eligibility

Participant inclusion criteria

Not provided at time of registration

Participant type

Patient

Age group

Not Specified

Gender

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).

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

15/08/2001

Recruitment end date

01/01/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Addenbrooke's NHS Trust
Cambridge
CB2 2QQ
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

Cambridge Consortium - Addenbrooke's (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes