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

NCT ID: NCT04751357

Last Updated: 2021-02-15

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 21 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-08-01
• Study Completion Date: 2022-06-01

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

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

ECA-Test (Clot-Pro)

Thrombelastometric ECA-Test performed on Clot-Pro

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Vienna

OTHER

Sponsor Role: lead

Responsible Party

Dr. Georg Scheriau

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Medical University of Vienna, General Hospital

Vienna, , Austria

Site Status: RECRUITING

Countries

Austria

Central Contacts

Georg Scheriau, MD

Role: CONTACT

georg.scheriau@meduniwien.ac.at

+4314040041090

Barbara Steinlechner, MD

Role: CONTACT

barbara.steinlechner@meduniwien.ac.at

+4314040041090

Facility Contacts

Barbara Steinlechner, MD

Role: primary

barbara.steinlechner@meduniwien.ac.at

+43140400 ext. 41090

Other Identifiers

EK Nr: 1635/2020

Identifier Type: -

Identifier Source: org_study_id