Monitoring Anticoagulation in Patients on ECMO for Severe Lung Failure

University Hospital Ostrava

Status: Completed

Conditions: COVID-19; ARDS

Treatments: Drug: Heparin; Drug: Argatroban Injection

Study type: Observational

Funder types: Other

Identifiers

NCT06038682

FNO-KARIM-Argatroban

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 100 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Exclusion criteria

• age under 18 years

Trial design

100 participants in 2 patient groups

Argatroban anticoagulation

Description:

Study subjects in this group will receive Argatroban anticoagulation.

Treatment:

Drug: Argatroban Injection

Heparin anticoagulation

Description:

Study subjects in this group will receive Heparin anticoagulation.

Treatment:

Drug: Heparin