Effect of Rivaroxaban on Coagulation Parameters- an ex Vivo Study

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00986635

Enrollment

100

Registered

2009-09-30

Start date

2009-09-30

Completion date

2011-04-30

Last updated

2011-04-08

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

Conditions

Differences in Laboratory Coagulation Parameters

Keywords

Activated partial thromboplastin time, Thrombin clotting Time, Anti-Xa-activity, Factor X-activity, Factor XIII-activity, Antithrombin (based on factor II), Antithrombin (based on factor X<9

Brief summary

Rivaroxaban represent a new class of anticoagulation agents. As an oral direct factor Xa 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 Xarelto® on different coagulation parameters.

Detailed description

To validate the effects of Rivaroxaban on coagulation parameters plasma samples of patients after hip or knee replacement surgery treated with Rivaroxaban 10 mg/d are investigated. Plasma samples are obtained by blood collection before, after 2 hours and after 12 hours after Rivaroxaban dosing in steady state (on 3rd - 5th day). Several techniques, including clot-based tests, chromogenic assays and ELISA´s are used for coagulation assays in our coagulation laboratory Frankfurt/Main. The influence of Rivaroxaban on different coagulation assays should be investigated in our coagulation laboratory.

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

* patients after hip or knee replacement surgery treated with Rivaroxaban 10 mg/d * must be able to accept blood sampling

Countries

Germany

Outcome results