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ENhanced recovery and ABbreviated LEngth of Anticoagulation for Thromboprophylaxis after primary Hip Arthroplasty
EU CTIS ID: 2023-507490-18-00
What this study is testing
To investigate whether, in patients undergoing elective THA following a fast-track protocol that includes modern surgical techniques as well as early mobilization and discharge of patients from the hospital after surgery, reduced duration (10 days) of postoperative thromboprophylaxis with a direct (non-vitamin K antagonist) oral anticoagulant (DOAC) is non-inferior to the standard duration (35 days) of thromboprophylaxis with regard to prevention of acute symptomatic venous thromboembolism (VTE), defined as symptomatic proximal deep vein thrombosis (DVT) or symptomatic or fatal pulmonary embolism (PE).
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
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 as per fast-track protocol including early mobilization and discharge from the hospital after surgery
- 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)
- Negative serum pregnancy test and highly effective method of contraception for the duration of study treatment
You likely can't join if
- Previous DVT or PE
- Active or recent major bleeding at any site, or presence of any major risk factor, which, in the judgment of the investigator, may significantly increase the bleeding risk during postoperative anticoagulation treatment
- Any 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 f100 mg daily or clopidogrel 75 mg daily
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 as per fast-track protocol including early mobilization and discharge from the hospital after surgery
- 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)
- Negative serum pregnancy test and highly effective method of contraception for the duration of study treatment
- Previous DVT or PE
- Active or recent major bleeding at any site, or presence of any major risk factor, which, in the judgment of the investigator, may significantly increase the bleeding risk during postoperative anticoagulation treatment
- Any 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 f100 mg daily or clopidogrel 75 mg daily
- Previous participation in this trial
- Life expectancy < 6 months
- Participation in another interventional clinical trial at inclusion or within the last 30 days prior to inclusion, except during the observational follow-up period of that other trial
- 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.
- 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 within the past six months
- Active peptic ulcer disease or gastritis, or gastrointestinal bleeding within the past three months
- 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., diarrhea, malabsorption], psychiatric illness)
The study team makes the final eligibility decision.
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, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.