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Evaluating the benefits of stocking and heparin in DVT prevention

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN13911492
Enrollment
2236
Registered
2016-01-27
Start date
2016-05-01
Completion date
Unknown
Last updated
2023-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Venous thromboembolism Circulatory System Prevention of venous thromboembolism (VTE) in patients undergoing surgery

Interventions

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 recommen

Sponsors

Imperial College London
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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)

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 18, 2026