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

Launched by PROF. STAVROS KONSTANTINIDES, MD · Sep 23, 2024

Keywords

ClinConnect Summary

The ENABLE-Hip trial is studying how long patients should take blood-thinning medication after having hip replacement surgery. This surgery can increase the risk of blood clots, so doctors usually prescribe anticoagulants to help prevent this. In this trial, researchers want to find out if taking the medication for just 10 days after surgery is as effective as the standard 35-day treatment. Participants will be monitored for 90 days to see if they experience any serious blood clots.

To join the trial, individuals need to be between 18 and 85 years old and scheduled for a hip replacement. They should be able to move around well before surgery and understand the study requirements. Participants will receive either the shorter or the longer anticoagulation regimen and will have follow-up visits after surgery. This study could help reduce the time patients need to be on blood thinners, which may lower the risk of side effects like bleeding.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Written informed consent
• • 2. Age between 18 and 85 years
• • 3. Scheduled to undergo elective unilateral primary THA and eligible for perioperative management based on the ERAS protocol
• • 4. Baseline Timed Up and Go (TUG) test scoring \< 20 seconds, corresponding to a good mobility status before surgery
• • 5. 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).
• 6. Pregnancy and contraception:
• • 1. Pregnancy test: Negative serum pregnancy test at screening for women of childbearing potential (WOCBP).
• • 2. 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.
• Exclusion Criteria:
• • 1. Previous DVT or PE
• • 2. Hip or lower limb fracture in the previous three months
• • 3. Major surgical procedure within the previous three months
• • 4. Active cancer defined as metastatic cancer, or cancer requiring chemotherapy or radiation therapy
• • 5. Active peptic ulcer disease, gastritis, or prior gastrointestinal bleeding
• • 6. Obesity with body mass index (BMI) \> 40 kg/m2 body surface area
• • 7. Severe renal impairment defined as estimated glomerular filtration rate \< 30ml/min
• • 8. Severe hepatic impairment defined as Child Pugh Class B or C
• • 9. 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)
• • 10. 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
• • 11. Any other medical condition representing a contraindication to discharge within 6 days after surgery
• • 12. Expected requirement for major surgery within a 90-day period post THA
• • 13. Need for long-term anticoagulation (e.g., atrial fibrillation, previous VTE)
• • 14. Need for chronic antiplatelet therapy except for acetylsalicylic acid (ASA) at a dose ≤ 100 mg daily or clopidogrel 75 mg daily
• • 15. Previous participation in this trial
• • 16. Life expectancy \< 6 months
• • 17. Participation in another interventional clinical trial within the last 30 days prior to inclusion, unless during the observational follow-up period
• • 18. 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