RecruitingPhase 3NCT06611319

ENhanced Recovery and ABbreviated LEngth of Anticoagulation for Thromboprophylaxis After Primary Hip Arthroplasty


Sponsor

Prof. Stavros Konstantinides, MD

Enrollment

2,932 participants

Start Date

Nov 26, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

Surgical hip replacement (total hip arthroplasty, THA) is associated with a high risk of venous thromboembolism, but the appropriate duration of postoperative medical thromboprophylaxis ("anticoagulation") remains highly controversial. The international randomized controlled trial (RCT) "ENhanced recovery and ABbreviated LEngth of Anticoagulation for Thromboprophylaxis after primary Hip Arthroplasty" (ENABLE-Hip) will enroll patients undergoing elective THA that are eligible for early mobilization after surgery. The trial will compare a regimen of short-duration (10-day) postoperative anticoagulation (experimental group) to standard-duration (35-day) postoperative anticoagulation (control group) using the direct oral anticoagulant Rivaroxaban (brand name: Xarelto) at the recommended dose. Thus, ENABLE-Hip will be the first major RCT to directly test an overall reduction in the duration of post-THA thromboprophylaxis instead of replacing one antithrombotic drug or regimen by another. Follow-up visits after hospital discharge will be on day 35 and on day 90 after surgery. The primary outcome is acute symptomatic proximal deep vein thrombosis, or symptomatic or fatal pulmonary embolism, within 90 days after surgery. If ENABLE-Hip will demonstrate 'non-inferiority' of the experimental intervention, its benefits will be obvious, as patients are spared many days of unnecessary (and potentially harmful in terms of bleeding risk) anticoagulation.


Eligibility

Min Age: 18 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Placebo Oral Tablet and a drug called Prevention of Venous Thromboembolism for people with hip arthroplasty, total and prevention of venous thromboembolism. The study is currently recruiting participants at 6 locations. People eligible for this study include aged 18 Years to 85 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPrevention of Venous Thromboembolism

Direct oral anticoagulant

DRUGPlacebo Oral Tablet

Placebo


Locations(6)

Kepler University Medical Center, Orthopedics and Traumatology

Linz, Upper Austria, Austria

Sana Clinics Sommerfeld, Dpt. for Surgical Orthopaedics

Kremmen, Brandenburg, Germany

GPR Rüsselsheim Health and Care Center

Rüsselsheim am Main, Hesse, Germany

University Medical Center Mainz, Center for Orthopedics and Trauma Surgery

Mainz, Rhineland-Palatine, Germany

University Medical Center Dresden, University Center for Orthopaedics, Trauma & Plastic Surgery

Dresden, Saxony, Germany

Evangelical Forest Hospital Berlin - Orthopaedics and Trauma Surgery

Berlin, Germany

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NCT06611319


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