Examining the Benefit of Graduated Compression Stockings in the Prevention of vEnous Thromboembolism in Low-risk Surgical Patients

NCT ID: NCT05347550

Last Updated: 2024-03-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

21472 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-08

Study Completion Date

2025-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Hospital acquired thrombosis describes blood clots that form in the legs and lungs after someone is treated in hospital. Clots in the leg can cause swelling, pain and other problems. If a clot in the leg travels to the lungs, it may be life threatening. Having surgery increases the risk of developing blood clots.

People having short-stay surgery (who either go home the same day or who stay overnight but go home shortly afterwards) are at a much lower risk of developing a blood clot than those who stay in hospital for longer. These low-risk people are often given elastic stockings (which squeeze the leg muscles) to reduce the chance of a blood clot.

The risks of wearing the stockings are low but they can be uncomfortable. In the UK, there are over a million short stay surgeries performed each year and most of these people are given elastic stockings to wear. Stockings cost the NHS a lot of money and it remains unknown if they work.

This study will investigate if it is worthwhile to continue using elastic stockings in people having surgery where the risk of developing blood clots is low. Adults (over 18-years) who are at low risk of developing blood clots (assessed using a nationally recognised tool) will be included.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Venous Thromboembolism

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control - No graduated compression stockings

In those centres randomised to the control arm, participants will not receive Graduated Compression Stockings (GCS).

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention - The provision of graduated compression stockings

Centres randomised to the intervention arm, which is the current standard of care, will consist of participants receiving Graduated Compression Stockings (GCS). Clinical staff (e.g. theatre support workers) will issue stockings to all patients who are scheduled to undergo short-stay surgery. Participants will be instructed to wear their stockings just before undergoing the surgical procedure and to remove the stockings as soon as they are ambulant (i.e. after the procedure).

Group Type EXPERIMENTAL

Graduated Compression Stockings - Thromboembolic deterrent stockings

Intervention Type OTHER

Centres randomised to the intervention arm will consist of participants receiving GCS.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Graduated Compression Stockings - Thromboembolic deterrent stockings

Centres randomised to the intervention arm will consist of participants receiving GCS.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Adults (18-59 years of age) scheduled to undergo a surgical procedure with a hospital stay \<48 hours
* Individuals assessed as being at low-risk of developing VTE as per the DHRA Tool (i.e. no assessed thrombosis risk factors / scoring 0)

Exclusion Criteria

* Individuals with a contraindication to GCS
* Individuals assessed as being at moderate or high-risk of VTE as per the DHRA tool
* Individuals requiring therapeutic anticoagulation
* Individuals with thrombophilia/ thrombogenic disorder
* Individuals with a previous history of VTE
* Individuals requiring intermittent pneumatic compression therapy beyond theatre and recovery
* Individuals requiring extended thromboprophylaxis beyond discharge
* Female patients of childbearing age who have a positive pregnancy test
* Individuals with lower limb immobilisation
* Inability to provide informed consent
Minimum Eligible Age

18 Years

Maximum Eligible Age

59 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Edinburgh

OTHER

Sponsor Role collaborator

Universidad de Granada

OTHER

Sponsor Role collaborator

Imperial College London

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Alun Davies

Role: PRINCIPAL_INVESTIGATOR

Imperial College London

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Barnsley Hospital NHS Foundation Trust

Barnsley, , United Kingdom

Site Status RECRUITING

Frimley Health NHS Foundation Trust

Camberley, , United Kingdom

Site Status RECRUITING

Queen Victoria Hospital NHS Foundation Trust

East Grinstead, , United Kingdom

Site Status RECRUITING

Imperial College Hospital NHS Foundation Trust

London, , United Kingdom

Site Status RECRUITING

South Tees Hospitals NHS Foundation Trust

Middlesbrough, , United Kingdom

Site Status RECRUITING

The Newcastle upon Tyne Hospitals NHS Foundation Trust

Newcastle upon Tyne, , United Kingdom

Site Status RECRUITING

Sherwood Forest Hospital NHS Foundation Trust

Nottingham, , United Kingdom

Site Status RECRUITING

North Tees and Hartlepool NHS Foundation Trust

Stockton-on-Tees, , United Kingdom

Site Status RECRUITING

Somerset NHS Foundation Trust

Taunton, , United Kingdom

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United Kingdom

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Sarah Whittley

Role: CONTACT

0203 311 7371

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

22CX7651

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Venous Occlusion and Limb Swelling
NCT02241343 TERMINATED NA
JETi Lower Extremity Venous Thrombosis
NCT07027878 ACTIVE_NOT_RECRUITING
Compression Device Safety Study
NCT00732823 COMPLETED PHASE2