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

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Hip Arthroplasty, Total, Prevention of Venous Thromboembolism

In brief

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 facts

Study ID: NCT06611319
Run by: Prof. Stavros Konstantinides, MD
People needed: 2932
Starts: 2024-11-26
Expected to finish: 2027-07-01
Last updated by the study team: 2025-01-16

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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 \&lt; 20 seconds, corresponding to a good mobility status before surgery
Capability to understand and comply with the protocol requirements (e.g., sufficient knowledge of German language to answer the questionnaires, ability to swallow intact capsules).
Pregnancy and contraception:
Pregnancy test: Negative serum pregnancy test at screening for women of childbearing potential (WOCBP).
Contraception: WOCBP and men who are able to father a child, willing to be abstinent or use highly effective methods of birth control that result in a low failure rate of less than 1% per year when used consistently and correctly beginning at informed consent, for the duration of drug treatment and allowing for a safe wash out period of at least 5 days for female or for male subjects after the last dose of trial medication. This is a very conservative estimate, considering the 'worst case scenario' of a substantially prolonged half-life up to 13 hours (e.g., in older patients and/or those with renal dysfunction) (28), and calculating for at least 8 half-lives to ensure practically non-detectable levels and effects of rivaroxaban.

You may not qualify if…

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
Active peptic ulcer disease, gastritis, or prior gastrointestinal bleeding
Obesity with body mass index (BMI) \&gt; 40 kg/m2 body surface area
Severe renal impairment defined as estimated glomerular filtration rate \&lt; 30ml/min
Severe hepatic impairment defined as Child Pugh Class B or C
Uncontrolled intercurrent illness (i.e., active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, interstitial lung disease, serious gastrointestinal conditions [e.g., diarrhea, malabsorption], psychiatric illness)
Active or recent major bleeding at any site, or presence of any major risk factor for bleeding, which, in the judgment of the investigator, may significantly increase the bleeding risk during postoperative anticoagulation treatment
Any other medical condition representing a contraindication to discharge within 6 days after surgery
Expected requirement for major surgery within a 90-day period post THA
Need for long-term anticoagulation (e.g., atrial fibrillation, previous VTE)
Need for chronic antiplatelet therapy except for acetylsalicylic acid (ASA) at a dose ≤ 100 mg daily or clopidogrel 75 mg daily
Previous participation in this trial
Life expectancy \&lt; 6 months
Participation in another interventional clinical trial within the last 30 days prior to inclusion, unless during the observational follow-up period
History of hypersensitivity to the investigational medicinal product (IMP) or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the IMP

Where it is running

Kepler University Medical Center, Orthopedics and Traumatology — Linz, Upper Austria, Austria (enrolling)
Sana Clinics Sommerfeld, Dpt. for Surgical Orthopaedics — Kremmen, Brandenburg, Germany (enrolling)
GPR Rüsselsheim Health and Care Center — Rüsselsheim am Main, Hesse, Germany (enrolling)
University Medical Center Mainz, Center for Orthopedics and Trauma Surgery — Mainz, Rhineland-Palatine, Germany (enrolling)
University Medical Center Dresden, University Center for Orthopaedics, Trauma & Plastic Surgery — Dresden, Saxony, Germany (enrolling)
Evangelical Forest Hospital Berlin - Orthopaedics and Trauma Surgery — Berlin, Germany (enrolling)

Full record on ClinicalTrials.gov

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