Status:
COMPLETED
Safety of DAbigatran and RIvaroxaban Versus NAdroparin in the Prevention of Venous Thromboembolism After Knee Arthroplasty Surgery
Lead Sponsor:
Martini Hospital Groningen
Conditions:
Venous Thromboembolism
Eligibility:
All Genders
18-110 years
Phase:
PHASE3
Brief Summary
Rationale: After total knee arthroplasty (TKA) surgery, patients are at risk to develop venous thromboembolism (VTE) or deep venous thrombosis (DVT) potentially resulting in a fatal pulmonary embolis...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
September 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2014
Estimated Enrollment :
148 Patients enrolled
Trial Details
Trial ID
NCT01431456
Start Date
September 1 2013
End Date
October 1 2014
Last Update
June 7 2018
Active Locations (1)
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1
Martini Ziekenhuis
Groningen, Netherlands