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New treatment option for Hip Arthroplasty, Total
Official title ENhanced Recovery and ABbreviated LEngth of Anticoagulation for Thromboprophylaxis After Primary Hip Arthroplasty
ClinicalTrials.gov ID: NCT06611319
What this study is testing
What is Prevention of Venous Thromboembolism?
Prevention of Venous Thromboembolism is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for hip arthroplasty, total.
Also referred to as Rivaroxaban, Xarelto.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 85
You may be able to join 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 \< 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...
You likely can't join 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) \> 40 kg/m2 body surface area
See the full eligibility criteria
- 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
- 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...
- 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) \> 40 kg/m2 body surface area
- Severe renal impairment defined as estimated glomerular filtration rate \< 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...
- 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...
- 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 \< 6 months
- Participation in another treatment 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
The study team makes the final eligibility decision.
Where it's taking place
- Linz, Upper Austria, Austria
- Kremmen, Brandenburg, Germany
- Rüsselsheim am Main, Hesse, Germany
- Mainz, Rhineland-Palatine, Germany
- Dresden, Saxony, Germany
- Berlin, Germany
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Linz, Upper Austria, Austria; Kremmen, Brandenburg, Germany; Rüsselsheim am Main, Hesse, Germany; Mainz, Rhineland-Palatine, Germany; Dresden, Saxony, Germany; Berlin, Germany. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.