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

Johann Wolfgang Goethe University Hospital

Status: Completed

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

Study type: Observational

Funder types: Other

Identifiers

NCT01704053

NOAPOC-271/12

Details and patient eligibility

About

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).

Full 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.

Enrollment: 34 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)