Condition category
Circulatory System
Date applied
27/01/2016
Date assigned
27/01/2016
Last edited
17/07/2018
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
When a person is in hospital for an operation, they often spend a lot of time in bed, putting them at risk of deep vein thrombosis (DVT). DVT is where a blood clot develops in a deep vein in one or both of the legs, causing pain, swelling and long term complications such as leg ulcers. If a DVT is not treated, then there is a risk that part of the blood clot could break off and become stuck in one of the lungs, blocking blood supply (pulmonary embolism, PE). Together, these two conditions are known as venous thromboembolism (VTE), which is a leading cause of death and disability worldwide. The importance to preventing patients from developing VTE is widely recognized. The main strategies in place involve anticoagulant medications (which thin the blood so it cannot form the harmful clots) and mechanical devices such as elasticated compression stockings (which apply continuous pressure to the legs, helping to maintain bloodflow). Evidence for using elastic stockings to prevent VTE has been challenged, with a lack of evidence for the additional benefits of elastic stockings over and above the benefit of blood-thinning. If elastic stockings reduce VTE over and above blood thinners, these benefits need to be weighed against the disadvantages, such as discomfort, restricting blood flow to the leg, blistering, cost and staff needing to help patients to put them on. The aim of this study is to look at whether patients who wear elastic stockings as well as taking anticoagulant medication have a lower chance of developing VTE than patients who take anticoagulant medications only.

Who can participate?
Adults who are having surgery at a participating hospital, who are at risk of developing VTE.

What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group are given graduated compression stockings (specially designed compression stockings where the pressure is at the highest level around the ankle and becomes lower further up the leg) to wear during their hospital stay, as well as taking low molecular weight heparin (anticoagulant medication especially for treating VTE), the dosage of this is determined by each patients' individual characteristics. Participants in the second group take low molecular weight heparin only. Participants attend follow up appointments after 1 and 2-3 weeks, as well as 90 days after surgery, to have their legs scanned to check for the presence of any blood clots. Participants also complete a number of questionnaires in order to find out if their quality of life has improved.

What are the possible benefits and risks of participating?
There are no direct benefits of taking part as the treatments given (i.e. heparin plus stockings) are already provided in standard care. Participants benefit from receiving a scan for the presence of DVT in this study and so are able to receive treatment. There are no significant risks of taking part, however some participants may experience some side-effects from the medication or may find the compression stockings uncomfortable at first as they are very tight.

Where is the study run from?
At least seven NHS hospitals in England (UK)

When is the study starting and how long is it expected to run for?
December 2015 to November 2019

Who is funding the study?
National Institute for Health Research (UK)

Who is the main contact?
Miss Rebecca Lawton, r.lawton@imperial.ac.uk (from 26/04/2018)
Miss Francine Heatley, f.heatley@imperial.ac.uk (before 26/04/2018)

Trial website

Contact information

Type

Scientific

Primary contact

Miss Rebecca Lawton

ORCID ID

Contact details

Imperial College London
Section of Vascular Surgery
Room 14
4th Floor East Wing
Charing Cross Hospital
Fulham Palace Road
London
W6 8RF
United Kingdom
+44 (0)203 311 5204
r.lawton@imperial.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

20354

Study information

Scientific title

Examining the benefit of graduated compression stockings as an adjunct to low dose low molecular weight heparin in the prevention of venous thromboembolism in elective surgical inpatients identified as moderate or high risk for venous thromboembolism: A multi-centre randomised controlled trial

Acronym

GAPS

Study hypothesis

The aim of this study is to investigate whether treatment with elastic compression stockings and blood thinning medicines combined are more effective at preventing venous thromboembolism (VTE) than blood­thinning medicines alone.

Ethics approval

REC: London - City Road & Hampstead Research Ethics Committee, 08/02/2016, ref: 16/LO/0015

Study design

Pragmatic, multicentre randomised clinical trial

Primary study design

Interventional

Secondary study design

Randomised parallel trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Venous thromboembolism

Intervention

Participants are randomly allocated using a computer to one of two groups.

Group 1: Participants are treated with low molecular weight heparin (LMWH) as per standard clinical recommendations (dosing regimen depending on participant characteristics). These patients are also given either below- or above-knee graduated compression stockings (GCS) to wear as per advice of the treating clinician.

Group 2: Participants are treated with low molecular weight heparin (LMWH) alone as per standard clinical recommendations (dosing regimen depending on participant characteristics).

Participants in both groups are followed up 1, between 2 and 3 weeks and 90 days after surgery to receive duplex scanning checking for the presence of blood clots.

Intervention type

Other

Phase

Drug names

Primary outcome measure

Presence of VTE within 90 days of surgery is measured using duplex ultrasound scanning of lower limbs 1, 2-3 weeks and 90 days post surgery.

Secondary outcome measures

1. Compliance with stockings and LMWH is determined at 90 days
2. Overall mortality is determined at 90 days
3. Quality of life is measured using the EQ5D questionnaire at 90 days

Overall trial start date

01/12/2015

Overall trial end date

30/11/2019

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Current inclusion criteria as of 26/04/2018:
1. Aged 18 years or over (from Jan 2018 recruitment will be restricted to patients aged 65 years and above)
2. Capacity to provide informed consent
3. Elective surgical inpatients at a participating hospital
4. Moderate or high risk of venous thromboembolism (VTE)

Previous inclusion criteria:
1. Aged 18 years or over
2. Capacity to provide informed consent
3. Elective surgical inpatients at a participating hopsital
4. Moderate or high risk of venous thrombo­embolism (VTE)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 2236; UK Sample Size: 2236

Participant exclusion criteria

1. Contraindications to low molecular weight heparin (LMWH)
2. Contraindications to graduated compression stockings (GCS), including peripheral arterial disease, stroke patients,
individuals undergoing lower limb surgery
3. Documented or known thrombophilia or thrombogenic disorder
4. Individuals requiring therapeutic anticoagulation
5. Previous venous thrombo­embolism (VTE)
6. Patients having intermittent pneumatic compression (IPC) beyond theatre and recovery
7. Patients requiring inferior vena cava (IVC) filter
8. Pregnancy
9. Patients requiring extended thromboprophylaxis
10. Application of a cast or brace in theatre

Recruitment start date

01/05/2016

Recruitment end date

31/01/2019

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Charing Cross Hospital
Fulham Palace Road
London
W6 8RF
United Kingdom

Trial participating centre

Addenbrooke’s Hospital
Hills Road
Cambridge
CB2 0QQ
United Kingdom

Trial participating centre

University Hospital Southampton
Tremona Road
Southampton
SO16 6YD
United Kingdom

Trial participating centre

Guy’s Hospital
Great Maze Pond
London
SE1 9RT
United Kingdom

Trial participating centre

University Hospitals Birmingham NHS Foundation Trust
Lode Lane
Solihull
B91 2JL
United Kingdom

Trial participating centre

Portsmouth Hospitals NHS Trust
Southwick Hill Road Cosham
Portsmouth
PO6 3LY
United Kingdom

Sponsor information

Organisation

Imperial College London

Sponsor details

Joint Research Compliance Office
Charing Cross Hospital
Fulham Palace Road
London
W6 8RF
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

1. Planned publication and presentation of results at scientific meetings
2. Summaries of results will also be made available to Investigators for dissemination within their clinical areas (where appropriate and according to their discretion)
3. There will also be an online dissemination plan, with participants and healthcare professionals able to access results on a trial website, and appropriate use of social media (Twitter, Facebook, LinkedIn)
4. Trial participants will also be offered a mailed summary of the trial findings

Intention to publish date

01/12/2019

Participant level data

Not expected to be available

Basic results (scientific)

Publication list

2017 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/28396238

Publication citations

Additional files

Editorial Notes

17/07/2018: Internal review 26/04/2018: The following changes have been made: 1. The overall trial end date has been changed from 30/11/2018 to 30/11/2019. 2. The recruitment end date has been changed from 31/03/2018 to 31/01/2019. 3. Freeman Hospital, Newcastle has been removed as a trial centre and Portsmouth Hospitals NHS Trust has been added. 4. The main contact and trial end date have been updated in the plain English summary. 5. The intention to publish date has been changed from 01/12/2018 to 01/12/2019. 12/04/2017: Publication reference added.