Effect of Dabigatran on Coagulation parameters-an ex Vivo Study

NCT ID: NCT01112202

Last Updated: 2012-06-06

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

70 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-04-30

Study Completion Date

2011-04-30

Brief Summary

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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

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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).

Conditions

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Effect of Dabigatran 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

* Age \> 18 y

Exclusion Criteria

* Hemorrhagic disorder
* Liver disease
* Anemia
* Severe renal impairment
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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Department of Vascular Medicine, University Hospital Frankfurt

Locations

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Johann Wolfgang Goethe University Hospital

Frankfurt, , Germany

Site Status

Countries

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Germany

Other Identifiers

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Dabi2010

Identifier Type: -

Identifier Source: org_study_id

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