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Effect of New Oral Anticoagulants Dabigatran and Rivaroxaban on Point of Care Coagulation Testing - an Ex-Vivo Study

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.
 
ClinicalTrials.gov Identifier: NCT01704053
Recruitment Status : Completed
First Posted : October 11, 2012
Last Update Posted : August 15, 2014
Sponsor:
Information provided by (Responsible Party):
Dr. Matthias Klages, Johann Wolfgang Goethe University Hospital

Tracking Information
First Submitted Date October 8, 2012
First Posted Date October 11, 2012
Last Update Posted Date August 15, 2014
Study Start Date October 2012
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT01704053 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Effect of New Oral Anticoagulants Dabigatran and Rivaroxaban on Point of Care Coagulation Testing - an Ex-Vivo Study
Official Title Monitoring The Anticoagulatory Effects of Dabigatran and Rivaroxaban On Plasmatic and Cellular Coagulation by Rotational Thrombelastometry/-Graphy and Multiple Platelet Function Analyzer
Brief Summary The purpose of this study is determine whether point of care coagulation testing is able to map the anticoagulatory effects of new oral anticoagulants dabigatran and rivaroxaban. Used as devices are thrombelastometry/-graphy (ROTEM, TEG)and multiple platelet function analyzer (Multiplate).
Detailed Description Patients receiving dabigatran or rivaroxaban in therapeutic doses are recruited. Blood will be taken twice in correlation to the time of drug intake (before and 3 hours after drug intake). The results of thrombelastometry/-graphy and multiple platelet function analyzer will be compared directly with the concentrations determined by plasma concentration assays.
Study Type Observational
Study Design Observational Model: Case Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Primary Care Clinic. Patients with non-valvular atrial fibrillation who receive Dabigatran or Rivaroxaban for prevention of stroke and systemic embolism.
Condition Clot Formation and Platelet Aggregation in Point of Care Testing
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: October¬†10,¬†2012)
34
Original Estimated Enrollment Same as current
Actual Study Completion Date March 2014
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patients receiving Dabigatran or Rivaroxaban
  • Adults > 18 years

Exclusion Criteria:

  • Patients receiving concomittantly inhibitors of platelet function
  • Renal insufficiency (Creatinine > 1,5 mg/dl), Urea > 80 mg/dl)
  • Hemodialysis
  • Hepatic Dysfunction (AST > 30 U/l, ALT > 30 U/l)
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT01704053
Other Study ID Numbers NOAPOC-271/12
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Dr. Matthias Klages, Johann Wolfgang Goethe University Hospital
Study Sponsor Johann Wolfgang Goethe University Hospital
Collaborators Not Provided
Investigators Not Provided
PRS Account Johann Wolfgang Goethe University Hospital
Verification Date August 2014