NCT05735639 THRomboprophylaxis in Individuals Undergoing Superficial endoVEnous Treatment (THRIVE)
| NCT ID | NCT05735639 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Imperial College London |
| Condition | Venous Thromboembolism |
| Study Type | INTERVENTIONAL |
| Enrollment | 6,660 participants |
| Start Date | 2024-01-22 |
| Primary Completion | 2027-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 6,660 participants in total. It began in 2024-01-22 with a primary completion date of 2027-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Endovenous interventions are keyhole operations for varicose veins that are carried out from within the vein itself. Varicose veins are enlarged veins close to the surface of the skin. They are connected to the bigger deeper veins in the leg (known as deep veins). Because of this, operations to close the varicose veins can increase the chance of a blood clot forming in the deep veins. Blood clots in the deep veins happen in around 1 in 50 people after endovenous operations. A clot in the leg can cause swelling, pain, and other long-term problems. If a clot in the leg breaks off and travels to the lungs, it can cause problems with the lung' ability to move oxygen from the air into the blood and may, in rare cases, be life threatening. Varicose vein procedures may carry a slightly higher risk of blood clot formation, and we are currently unsure if current clot reducing medicines are beneficial in preventing blood clots in people having varicose vein procedures. This study will investigate if it is worthwhile prescribing medicines to reduce blood clots after varicose vein procedures.
Eligibility Criteria
Inclusion Criteria: * Adults (\>18 years) * Scheduled to undergo endovenous intervention of truncal varicose veins under local anaesthesia * Treatment technologies including radiofrequency, laser, mechanochemical, foam sclerotherapy and cyanoacrylate glue Exclusion Criteria: * Clinical indication for therapeutic anticoagulation e.g., atrial fibrillation * Previous personal or first-degree relative history of VTE * Thrombophilia * Female patients of childbearing potential who have a positive pregnancy test * A history of allergy to heparins or direct oral anticoagulants * A history of heparin-induced thrombocytopenia * Inherited and acquired bleeding disorders * Evidence of active bleeding * Concomitant major health problems such as active cancer and chronic renal and/or liver impairment * Known thrombocytopenia (platelets known to be less than 50 x 109 /l) * Surgery or major trauma in the previous 90 days * Recent ischemic stroke in the previous 90 days * Inability to provide consent
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05735639 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Venous Thromboembolism. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05735639 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05735639 currently recruiting?
Yes, NCT05735639 is actively recruiting participants. Contact the research team at s.whittley@imperial.ac.uk for enrollment information.
Where is the NCT05735639 trial being conducted?
This trial is being conducted at London, United Kingdom.
Who is sponsoring the NCT05735639 clinical trial?
NCT05735639 is sponsored by Imperial College London. The trial plans to enroll 6,660 participants.