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ENhanced Recovery and ABbreviated LEngth of Anticoagulation for Thromboprophylaxis After Primary Hip Arthroplasty
Sponsor: Prof. Stavros Konstantinides, MD
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.
Key Details
Gender
All
Age Range
18 Years - 85 Years
Study Type
INTERVENTIONAL
Enrollment
2932
Start Date
2024-11-26
Completion Date
2027-07
Last Updated
2025-01-16
Healthy Volunteers
No
Interventions
Prevention of Venous Thromboembolism
Direct oral anticoagulant
Placebo 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