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

Last updated: February 12, 2021
Sponsor: Medical University of Vienna
Overall Status: Active - Recruiting

Phase

N/A

Condition

Dysfunctional Uterine Bleeding

Platelet Disorders

White Cell Disorders

Treatment

N/A

Clinical Study ID

NCT04751357
EK Nr: 1635/2020
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

  • Heparin infusion in the last fourhours

Study Design

Total Participants: 21
Study Start date:
August 01, 2020
Estimated Completion Date:
June 01, 2022

Connect with a study center

  • Medical University of Vienna, General Hospital

    Vienna, 1090
    Austria

    Active - Recruiting

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