Official Title
Monitoring Anticoagulation With Argatroban in Patients on Extracorporeal Membrane Oxygenation for Severe Lung Failure Using Anti-FIIa. Monitoring Anticoagulation With Unfractionated Heparin in Patients on Extracorporeal Membrane Oxygenation for Severe Lung Failure Using Anti-FXa.
Brief Summary

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

Detailed 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.

Completed
ARDS
COVID-19

Drug: Argatroban Injection

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

Drug: Heparin

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

Eligibility Criteria

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

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: 80 Years
Countries
Czechia
Locations

University Hospital Ostrava
Ostrava 3068799, Moravian-Silesian Region, Czechia

Filip Burša, MD, Ph.D., Principal Investigator
University Hospital Ostrava

University Hospital Ostrava
NCT Number
Keywords
ECMO
ARDS (acute respiratory distress syndrome)
anticoagulation
thrombotic complications
LMWH (low-molecular-weight heparin)
Argatroban
MeSH Terms
COVID-19
Pulmonary Atelectasis
Argatroban
Heparin