Condition: Hip Arthroplasty, Total · Prevention of Venous Thromboembolism · Sponsor: Prof. Stavros Konstantinides, MD
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.
This description comes directly from the study's public registry record.
Nadine Martin, Dr. · +496131178376 · nadine.martin@unimedizin-mainz.de
Susanne Fischer, M.Sc. · +496131178382 · susanne.fischer@unimedizin-mainz.de
Always discuss trial participation with your own doctor first.
| Kepler University Medical Center, Orthopedics and Traumatology | Linz, Upper Austria, Austria | Recruiting |
| Sana Clinics Sommerfeld, Dpt. for Surgical Orthopaedics | Kremmen, Brandenburg, Germany | Recruiting |
| GPR Rüsselsheim Health and Care Center | Rüsselsheim am Main, Hesse, Germany | Recruiting |
| University Medical Center Mainz, Center for Orthopedics and Trauma Surgery | Mainz, Rhineland-Palatine, Germany | Recruiting |
| University Medical Center Dresden, University Center for Orthopaedics, Trauma & Plastic Surgery | Dresden, Saxony, Germany | Recruiting |
| Evangelical Forest Hospital Berlin - Orthopaedics and Trauma Surgery | Berlin, Germany | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06611319