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Argatroban Monitoring in Critically Ill Patients: Evaluation of a Novel Ecarin-based Bedside Test

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Medical University of Vienna

Status

Unknown

Conditions

Heparin-induced Thrombocytopenia

Treatments

Diagnostic Test: ECA-Test (Clot-Pro)

Study type

Observational

Funder types

Other

Identifiers

NCT04751357
EK Nr: 1635/2020

Details and patient eligibility

About

Argatroban is a parenteral direct Thrombininhibitor used for anticoagulation in patients suffering from heparin induced thrombocytopenia (HIT). There is increasing evidence suggesting that the activated partial thromboplastine time (aPTT), which is recommended for dosage monitoring, correlates poorly with serum argatroban concentration in critically ill patients. Therefore it may be badly suited to determine the correct dosing. Ecarin based tests have been proven to be effective in determining effects of direct thrombin inhibitors. The investigators now plan to evaluate a novel, rotational thrombelastometric, ecarin based bedside test for its ability to measure the effect of argatroban in critically ill patients. So far an excellent correlation of a similar test could be shown in spiked plasma of healthy adults. According to the manufacturer the ECA-Test is able to detect direct thrombininhibitors. However to our knowledge neither the ECA-Test nor other ecarin-based thrombelastometric tests have been studied in critically ill patients treated with argatroban. The investigators therefore seek to investigate the correlation of the ECA-Test (ClotPro®) with the serum argatroban concentration.

Enrollment

21 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Continuous infusion of Argatroban in routine clinical use according to local standard of care
  • Expected length of stay at ICU > 4 days
  • 18 years

Exclusion criteria

  • Heparin infusion in the last fourhours

Trial contacts and locations

1

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Central trial contact

Barbara Steinlechner, MD; Georg Scheriau, MD

Data sourced from clinicaltrials.gov

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