A randomized pilot study comparing the safety of DAbigatran and RIvaroxaban versus NAdroparin in the prevention of venous thromboembolism after knee arthroplasty surgery. DARINA

Martini Hospital Groningen0 个研究点开始时间: 2012年5月24日最近更新: 2012年6月26日

适应症

试验速览

暂无简介。

•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.

发起方

Martini Hospital Groningen