Enhanced recovery and Abbreviated Length of Anticoagulation for Thromboprophylaxis after primary Hip Arthroplasty – the ENABLE-Hip Trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 5,000
- 试验地点
- 6
- 主要终点
- The primary efficacy endpoint is acute symptomatic or fatal VTE, defined as (i) symptomatic DVT of the popliteal or more proximal leg veins (femoral or iliac veins) or inferior vena cava, or (ii) symptomatic (segmental or more proximal) or fatal PE, occurring in the first 90 days after enrolment and confirmed by objective testing.
研究概览
简要总结
To investigate whether, in patients undergoing elective THA following ERAS protocol, 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).
研究设计
- 分配方式
- Randomized
- 主要目的
- Period 1
- 盲法
- Double (Monitor, Carer, Investigator, Subject)
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Written informed consent
- •Age between 18 and 85 years
- •Scheduled to undergo elective unilateral primary THA and eligible for perioperative management as per 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)
- •Negative serum pregnancy test and highly effective method of contraception for the duration of study treatment
排除标准
- •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 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.
- •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., diarrhea, malabsorption], psychiatric illness)
结局指标
主要结局
The primary efficacy endpoint is acute symptomatic or fatal VTE, defined as (i) symptomatic DVT of the popliteal or more proximal leg veins (femoral or iliac veins) or inferior vena cava, or (ii) symptomatic (segmental or more proximal) or fatal PE, occurring in the first 90 days after enrolment and confirmed by objective testing.
The primary efficacy endpoint is acute symptomatic or fatal VTE, defined as (i) symptomatic DVT of the popliteal or more proximal leg veins (femoral or iliac veins) or inferior vena cava, or (ii) symptomatic (segmental or more proximal) or fatal PE, occurring in the first 90 days after enrolment and confirmed by objective testing.
次要结局
- Death from any cause
- isolated symptomatic distal DVT
- myocardial infarction or stroke
- need for readmission to the hospital and length of hospital stay;
- serious adverse events (SAEs)
- patient mobility
- changes in patientreported hip joint-specific disability following surgery
- generic quality of life
- postoperative healthcare resource utilization
- Overt major or clinically relevant non-major bleeding
研究者
Sponsor contact point clinical trials
Scientific
Universitaetsmedizin Der Johannes Gutenberg-Universitaet Mainz Koerperschaft Des Offentlichen Rechts