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Effect of Dabigatran on Coagulation parameters-an ex Vivo Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01112202
First Posted: April 28, 2010
Last Update Posted: June 6, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Johann Wolfgang Goethe University Hospital
  Purpose
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
Effect of Dabigatran in Laboratory Coagulation Parameters

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Effect of Dabigatran on Coagulation Parameters in Patients Undergoing Elective Orthopaedic Surgery

Resource links provided by NLM:


Further study details as provided by Johann Wolfgang Goethe University Hospital:

Estimated Enrollment: 70
Study Start Date: April 2010
Study Completion Date: April 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
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).
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
  Contacts and Locations
Information from the National Library of Medicine

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

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 Submitted: April 27, 2010
First Posted: April 28, 2010
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:
Dabigatran
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants