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

Completed

• Conditions: Clot Formation and Platelet Aggregation in Point of Care Testing

• Registration Number: NCT01704053
• Lead Sponsor: Johann Wolfgang Goethe University Hospital

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 Timeline

• Study Start: 2012-10
• Study First Submitted: 2012-10-08
• Study First Submitted QC: 2012-10-10
• Study First Posted: 2012-10-11
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-14
• Last Update Posted: 2014-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

University Hospital of University hospital of Frankfurt/Main, Department of Anesthesiology, Intensive-Care Medicine and Pain Therapy; 🇩🇪 Frankfurt/Main, Hessen, Germany