About this trial
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 criteria
Qualifiers
Written informed consent
Age between 18 and 85 years
Scheduled to undergo elective unilateral primary THA and eligible for perioperative management based on the ERAS protocol
Baseline Timed Up and Go (TUG) test scoring < 20 seconds, corresponding to a good mobility status before surgery
Disqualifiers
Previous DVT or PE
Hip or lower limb fracture in the previous three months
Major surgical procedure within the previous three months
Active cancer defined as metastatic cancer, or cancer requiring chemotherapy or radiation therapy
Trial design
Treatments tested in this trial
- Prevention of Venous Thromboembolism
- Placebo Oral Tablet
Treatment groups
Sponsors and collaborators
Prof. Stavros Konstantinides, MD
Lead sponsor
Johannes Gutenberg University Mainz
Sponsor institution