Effect of Dabigatran on Coagulation parameters-an ex Vivo Study

This study has been completed.
Sponsor:
Information provided by:
Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier:
NCT01112202
First received: April 27, 2010
Last updated: June 5, 2012
Last verified: April 2010
  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 Hospitals:

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01112202

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

No publications provided

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
Study First Received: April 27, 2010
Last Updated: June 5, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Johann Wolfgang Goethe University Hospitals:
direct thrombin inhibitors
Dabigatran
Coagulation parameters

Additional relevant MeSH terms:
Dabigatran
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anticoagulants
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 16, 2014