Effect of Rivaroxaban on Coagulation Parameters- an ex Vivo Study

NCT ID: NCT00986635

Last Updated: 2011-04-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-09-30

Study Completion Date

2011-04-30

Brief Summary

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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

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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.

Conditions

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Differences in Laboratory Coagulation Parameters

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Johann Wolfgang Goethe University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Vascular Medicine, Johann Wolfgang Goethe University Hospital Frankfurt/Main

Principal Investigators

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Helen Mani, PhD

Role: PRINCIPAL_INVESTIGATOR

Johann Wolfgang Goethe University Hospital Frankfurt/Main Germany

Locations

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University Hospital Frankfurt

Frankfurt am Main, , Germany

Site Status

Countries

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Germany

References

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Mani H, Hesse C, Stratmann G, Lindhoff-Last E. Ex vivo effects of low-dose rivaroxaban on specific coagulation assays and coagulation factor activities in patients under real life conditions. Thromb Haemost. 2013 Jan;109(1):127-36. doi: 10.1160/TH12-04-0228. Epub 2012 Nov 8.

Reference Type DERIVED
PMID: 23138190 (View on PubMed)

Other Identifiers

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RIV139/09

Identifier Type: -

Identifier Source: org_study_id

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