Effect of Dabigatran on Coagulation parameters-an ex Vivo Study

Johann Wolfgang Goethe University Hospital

Status

Completed

Conditions

Effect of Dabigatran in Laboratory Coagulation Parameters

Study type

Observational

Funder types

Other

Identifiers

NCT01112202

Dabi2010

Details and patient eligibility

About

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.

Full description

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).

Enrollment

70 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria