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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-85
SponsorProf. Stavros Konstantinides, MD

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

2,932 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Prof. Stavros Konstantinides, MD

Lead sponsor

Johannes Gutenberg University Mainz

Sponsor institution