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

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.

Study Overview

• Status: Recruiting
• Conditions: Heparin-induced Thrombocytopenia
• Intervention / Treatment: Diagnostic test: ECA-Test (Clot-Pro)

• Study Type: Observational
• Enrollment (Anticipated): 21

Contacts and Locations

• Study Contact: Name: Georg Scheriau, MD; Phone Number: +4314040041090; Email: georg.scheriau@meduniwien.ac.at
• Study Contact Backup: Name: Barbara Steinlechner, MD; Phone Number: +4314040041090; Email: barbara.steinlechner@meduniwien.ac.at

Study Locations

• Austria
  • Vienna, Austria, 1090
    • Recruiting
    • Medical University of Vienna, General Hospital
    • Contact: Barbara Steinlechner, MD; Phone Number: 41090 +43140400; Email: barbara.steinlechner@meduniwien.ac.at

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients at the Intensive Care Unit who receive a continuous infusion of argatroban are eligible for inclusion.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Medical University of Vienna

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2020
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): June 1, 2022

Study Registration Dates

• First Submitted: February 8, 2021
• First Submitted That Met QC Criteria: February 8, 2021
• First Posted (Actual): February 12, 2021

Study Record Updates

• Last Update Posted (Actual): February 15, 2021
• Last Update Submitted That Met QC Criteria: February 12, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: ROTEM; Argatroban; ECA-Test; Ecarin; Clot-Pro; Thrombelastometry
• Additional Relevant MeSH Terms: Hematologic Diseases; Blood Platelet Disorders; Thrombocytopenia
• Other Study ID Numbers: EK Nr: 1635/2020

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No