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

NCT04751357 | Unknown

• 1 other identifier: EK Nr: 1635/2020
• Study Type: observational
• Target: 21
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Heparin-induced Thrombocytopenia

Keywords

Argatroban; ECA-Test; Ecarin; Clot-Pro; Thrombelastometry; ROTEM

Outcome Measures

Primary Outcomes (1)

• 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.

Interventions

ECA-Test (Clot-Pro) DIAGNOSTIC_TEST

Thrombelastometric ECA-Test performed on Clot-Pro

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Heparin infusion in the last fourhours

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical University of Vienna, General Hospital

Vienna, 1090, Austria

RECRUITING

Central Study Contacts

Georg Scheriau, MD

CONTACT

+4314040041090; georg.scheriau@meduniwien.ac.at

Barbara Steinlechner, MD

CONTACT

+4314040041090; barbara.steinlechner@meduniwien.ac.at

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: February 8, 2021
• First Posted: February 12, 2021
• Study Start: August 1, 2020
• Primary Completion: December 31, 2021
• Study Completion: June 1, 2022
• Last Updated: February 15, 2021

Record last verified: 2021-02

Locations

AU (1)