Monitoring Anticoagulation in Patients on ECMO for Severe Lung Failure

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-04-01

Study Completion Date

2023-12-31

Brief Summary

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A monocentric observational study evaluates the accuracy of anticoagulation monitoring in critically ill patients on ECLS (extracorporeal life support) using new markers of the effect of direct thrombin inhibitors and also the accuracy of anticoagulation monitoring in patients on unfractionated heparin using anti-Xa. A more accurate setting of anticoagulation may lead to a reduction in the number of serious bleeding and thrombotic complications in these patients.

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Detailed Description

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Anticoagulation using a direct thrombin inhibitor, argatroban, is one of the modern options for anticoagulation in patients on VV (veno-venous) ECMO (extracorporeal membrane oxygenation) support, and in 2021 the ECMO center of the University Hospital Ostrava changed the standard anticoagulation using UHF (unfractionated heparin) to anticoagulation using Argatroban as a new standard of routine care. Argatroban shows more stable levels and has a short half-life, and a number of foreign ECMO centers have been using Argatroban for a long time also as basic anticoagulation in all ECMO patients.

To monitor the effect of direct thrombin inhibitors, it is possible to use monitoring of anti-FIIa activity, which directly assesses the effect of the anticoagulant on thrombin activity. Anticoagulation with Argatroban may reduce the risk of serious bleeding complications. Target values of aPTT (Activated Partial Thromboplastin Time) and anti-FIIa can be determined according to ELSO (Extracorporeal Life Support Organization) guidelines.

Conditions

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ARDS COVID-19

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Argatroban anticoagulation

Study subjects in this group will receive Argatroban anticoagulation.

Argatroban Injection

Intervention Type DRUG

Argatroban will be administered to the study subjects in this group in order to achieve anticoagulation.

Heparin anticoagulation

Study subjects in this group will receive Heparin anticoagulation.

Heparin

Intervention Type DRUG

Heparin will be administered to the study subjects in this group in order to achieve anticoagulation.

Interventions

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Argatroban Injection

Argatroban will be administered to the study subjects in this group in order to achieve anticoagulation.

Intervention Type DRUG

Heparin

Heparin will be administered to the study subjects in this group in order to achieve anticoagulation.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients with COVID-19
* ARDS according to the Berlin definition
* Veno-venous (VV) ECMO
* Full coagulation with Argatroban or heparin to an anti-FIIa value of 0.4-1.5 or aPTT 50-60