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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Effect of Dabigatran in Laboratory Coagulation Parameters

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Johann Wolfgang Goethe University Hospital

Frankfurt, 60590, Germany

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Age > 18 y

Exclusion criteria

Hemorrhagic disorder
Liver disease
Anemia
Severe renal impairment

Sponsors and collaborators

Lead sponsor

Johann Wolfgang Goethe University Hospital

Other

Registry information

Official study title

Effect of Dabigatran on Coagulation Parameters in Patients Undergoing Elective Orthopaedic Surgery

Important dates

Study start: 2010
Primary completion: 2011
Study completion: 2011
First posted: Apr 28, 2010
Registry last updated: Jun 6, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.