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Trial record 92 of 333 for:    DABIGATRAN

Effect of Dabigatran on Coagulation parameters-an ex Vivo Study

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ClinicalTrials.gov Identifier: NCT01112202
Recruitment Status : Completed
First Posted : April 28, 2010
Last Update Posted : June 6, 2012
Sponsor:
Information provided by:
Johann Wolfgang Goethe University Hospital

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.

Condition or disease
Effect of Dabigatran in Laboratory 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).

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Study Type : Observational
Estimated Enrollment : 70 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Effect of Dabigatran on Coagulation Parameters in Patients Undergoing Elective Orthopaedic Surgery
Study Start Date : April 2010
Actual Primary Completion Date : February 2011
Actual Study Completion Date : April 2011

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
patients after hip or knee replacement surgery treated with Dabigatran 150-220 mg/d
Criteria

Inclusion Criteria:

  • Age > 18 y

Exclusion Criteria:

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

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01112202


Locations
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Germany
Johann Wolfgang Goethe University Hospital
Frankfurt, Germany, 60590
Sponsors and Collaborators
Johann Wolfgang Goethe University Hospital

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Responsible Party: Prof. Edelgard Lindhoff-Last, Department of Vascular Medicine, University Hospital Frankfurt
ClinicalTrials.gov Identifier: NCT01112202     History of Changes
Other Study ID Numbers: Dabi2010
First Posted: April 28, 2010    Key Record Dates
Last Update Posted: June 6, 2012
Last Verified: April 2010
Keywords provided by Johann Wolfgang Goethe University Hospital:
direct thrombin inhibitors
Dabigatran
Coagulation parameters
Additional relevant MeSH terms:
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Dabigatran
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants