A randomized pilot study comparing the safety of DAbigatran and RIvaroxaban versus NAdroparin in the prevention of venous thromboembolism after knee arthroplasty surgery. DARINA
- Conditions
- After total knee arthroplasty (TKA) surgery, patients are at risk to develop venous thromboembolism (VTE). Two novel agents, dabigatran and rivaroxaban, recently gained market authorisation for prevention of venous thromboembolism after knee arthroplasty.Our aim is to compare the long term use of dabigatran and rivaroxaban versus nadroparin on safety after total knee arthroplasty (TKA)Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]
- Registration Number
- EUCTR2011-003556-39-NL
- Lead Sponsor
- Martini Hospital Groningen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
Patients > 18 years and weighing more than 40 kg who are scheduled for primary elective total knee arthroplasty according to the ‘joint care program’ and want to provided signed informed consent are eligible for the study.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 75
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 75
Patients will be excluded if they meet one of the following exclusion criteria.
-a known inherited or acquired clinically significant active high risk of bleeding or bleeding disorder;
-major surgery, trauma, uncontrolled severe arterial hypertension, or myocardial infarction within the last 3 months;
-history of acute intracranial disease or hemorrhagic stroke;
-gastrointestinal or urogenital bleeding or ulcer disease within the last 6 months;
-cirrhotic patients with moderate hepatic impairment (aspartate or alanine aminotransferase (AST, ALT) levels higher than 2x the upper limit of the normal range (ULN) within the last month);
-severe renal insufficiency (creatinine clearance < 30 mL/min);
-treatment with anticoagulants during study drug treatment;
-active malignant disease;
-pregnancy or breastfeeding;
-and unable to give informed consent.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method