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NCT04751357 Clinical Trial

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

Heparin-induced Thrombocytopenia Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04751357
Other study ID # EK Nr: 1635/2020
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date August 1, 2020
Est. completion date June 1, 2022

Study information
Verified date February 2021
Source Medical University of Vienna
Contact Georg Scheriau, MD
Phone +4314040041090
Email georg.scheriau@meduniwien.ac.at
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 21
Est. completion date June 1, 2022
Est. primary completion date December 31, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• ECA-Test (Clot-Pro)
Thrombelastometric ECA-Test performed on Clot-Pro

Locations
Country Name City State
Austria Medical University of Vienna, General Hospital Vienna

Sponsors (1)
Lead Sponsor Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome
Type Measure Description Time frame Safety issue
Primary Correlation of ECA-Test CT with Argatroban Plasma Concentration Correlation of ECA-Test CT with Argatroban Plasma Concentration on five consecutive days ECA-Test CT and Argatroban Plasma Concentration will be measured on five consecutive days starting with inclusion in the study on day 0.
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