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

• ClinicalTrials.gov Identifier: NCT01704053
• Recruitment Status: Completed
• First Posted: October 11, 2012
• Last Update Posted: August 15, 2014
• Sponsor: Johann Wolfgang Goethe University Hospital
• 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
• 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

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

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