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

Monitoring The Anticoagulatory Effects of Dabigatran and Rivaroxaban On Plasmatic and Cellular Coagulation by Rotational Thrombelastometry/-Graphy and Multiple Platelet Function Analyzer

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01704053

Enrollment

Registered

2012-10-11

Start date

2012-10-31

Completion date

2014-03-31

Last updated

2014-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Clot Formation and Platelet Aggregation in Point of Care Testing

Keywords

New Oral Anticoagulants, Dabigatran, Rivaroxaban, Thrombelastometry/-graphy (ROTEM, TEG), Multiple Platelet Function Analyzer (Multiplate)

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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)

Countries

Germany

Outcome results