Effect of Dabigatran on Coagulation parameters-an ex Vivo Study

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01112202

Enrollment

Registered

2010-04-28

Start date

2010-04-30

Completion date

2011-04-30

Last updated

2012-06-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Effect of Dabigatran in Laboratory Coagulation Parameters

Keywords

direct thrombin inhibitors, Dabigatran, Coagulation parameters

Brief summary

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.

Detailed 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).

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Age \> 18 y

Exclusion criteria

* Hemorrhagic disorder * Liver disease * Anemia * Severe renal impairment

Countries

Germany

Outcome results