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

Sponsor

Medical University of Vienna (Other)

Overall Status

Recruiting

CT.gov ID

NCT04751357

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Heparin-induced Thrombocytopenia	Diagnostic Test: ECA-Test (Clot-Pro)

Study Design

Study Type:

Observational

Anticipated Enrollment :

21 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Aug 1, 2020

Anticipated Primary Completion Date :

Dec 31, 2021

Anticipated Study Completion Date :

Jun 1, 2022

Outcome Measures

Primary Outcome Measures

Correlation of ECA-Test CT with Argatroban Plasma Concentration [ECA-Test CT and Argatroban Plasma Concentration will be measured on five consecutive days starting with inclusion in the study on day 0.]
Correlation of ECA-Test CT with Argatroban Plasma Concentration on five consecutive days

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medical University of Vienna, General Hospital	Vienna		Austria	1090

Sponsors and Collaborators

Medical University of Vienna

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Dr. Georg Scheriau, Principal investigator, Medical University of Vienna

ClinicalTrials.gov Identifier:

NCT04751357

Other Study ID Numbers:

EK Nr: 1635/2020

First Posted:

Feb 12, 2021

Last Update Posted:

Feb 15, 2021

Last Verified:

Feb 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Dr. Georg Scheriau, Principal investigator, Medical University of Vienna

Additional relevant MeSH terms:

Thrombocytopenia

Study Results

No Results Posted as of Feb 15, 2021