A randomised controlled trial investigating the effects of compression stockings in patients who require blood thinning medication post discharge from elective surgery

Graduated compression stocking as an adjunct to extended duration pharmacological thromboprophylaxis for venous thromboembolism prevention

Registry ID
ISRCTN11667770
Source registry
ISRCTN
Status
Recruiting
Study type
INTERVENTIONAL
Sponsor
Imperial College London
Enrollment
4696
Start date
2024-05-01
Completion date
2027-11-30
Last update
2026-08-17

Conditions

Summary

Venous thromboembolism

Detailed description

Baseline Visit (Visit 0): Consenting participants will be randomised in a 1:1 fashion to one of two thromboprophylaxis strategies: 1. Extended duration pharmacological thromboprophylaxis (EDPTP)* in addition to GCS (control arm), or 2. EDPTP alone (intervention arm) *EDPTP includes any anti-thrombotic agent prescribed at a prophylactic dose for prevention of VTE, including low-molecular-weight heparin (LMWH), Directly acting Oral AntiCoagulants (DOACs), or antiplatelet therapy. Participants are deemed to require extended duration thromboprophylaxis measures as per local policy in line with NICE [NG89] guidelines. Examples of procedures from which patients are at the highest risk of VTE include (but are not limited to): orthopaedic surgery (total hip replacement, total knee replacement, colorectal surgery (colectomy, splenectomy), upper gastrointestinal surgery (oesophagectomy, gastrectomy), urological surgery (cystectomy, nephrectomy), and gynaecological oncology surgery (radical hysterectomy, radical trachelectomy). Intervention arm: Participants randomised to the intervention arm will receive EDPTP alone post-surgery (no GCS). Extended-duration pharmacological thromboprophylaxis is the practice of prescribing thromboprophylaxis for a duration after hospital discharge. Prevention of DVT is a licenced indication and recommended by NICE guidelines [NG89] for several Low molecular weight heparins (LMWH) such as tinzaparin, enoxaparin, or direct oral anticoagulants (DOACs) such as rivaroxaban, apixaban. Aspirin is an antiplatelet medication that reduces platelet function with a variety of clinical indications. The use of aspirin as DVT prophylaxis in orthopaedic surgery is also recommended by NICE [NG89]. Prophylactic-dose thromboprophylaxis is prescribed at a lower dose in comparison to clinical indications for therapeutic anticoagulation, such as in the treatment of diagnosed DVT or PE. Control arm: Participants randomised to the control arm will receive both EDPTP

Interventions

Inclusion criteria

1. Adults (>18 years) 2. Participants undergoing elective surgery; risk assessed as requiring EDPTP. Participants are deemed to require extended duration thromboprophylaxis measures as per local policy in line with NICE [NG89] guidelines. Examples of procedures from which patients are at the highest risk of VTE include (but are not limited to): orthopaedic surgery (total hip replacement, total knee replacement, colorectal surgery (colectomy, splenectomy), upper gastrointestinal surgery (oesophagectomy, gastrectomy), urological surgery (cystectomy, nephrectomy), and gynaecological oncology surgery (radical hysterectomy, radical trachelectomy).

Exclusion criteria

1. Contraindications to EDPTP or GCS 2. Individuals requiring therapeutic anticoagulation e.g., anticoagulation for previous DVT 3. Known thrombophilia or thrombogenic disorder

Locations

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