Effect of Dabigatran on Coagulation parameters-an ex Vivo Study
Dabigatran represent a new class of promising anticoagulation agents. As an oral direct thrombin inhibitor it has been effective in preventing venous thromboembolism in patients undergoing elective orthopaedic surgery. This ex vivo study is undertaken to investigate the ex-vivo effects of Pradaxa® on different coagulation parameters.
Effect of Dabigatran in Laboratory Coagulation Parameters
|Study Design:||Observational Model: Cohort
Time Perspective: Retrospective
|Official Title:||Effect of Dabigatran on Coagulation Parameters in Patients Undergoing Elective Orthopaedic Surgery|
|Study Start Date:||April 2010|
|Study Completion Date:||April 2011|
|Primary Completion Date:||February 2011 (Final data collection date for primary outcome measure)|
This mono-centric, open-label study is undertaken to validate the effects of Dabigatran on coagulation parameters in plasma samples of 70 patients after hip or knee replacement surgery treated with Dabigatran 150-220 mg/d. Plasma samples are obtained by blood collection before, after 2 hours and after 12-14 hours after Dabigatran dosing in steady state (on 3rd - 5th day).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01112202
|Johann Wolfgang Goethe University Hospital|
|Frankfurt, Germany, 60590|