Clinical trial NCT06038682: Monitoring Anticoagulation in Patients on ECMO for Severe Lung Failure
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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: ARDS
COVID-19
Keywords: ECMO
ARDS (acute respiratory distress syndrome)
anticoagulation
thrombotic complications
LMWH (low-molecular-weight heparin)
Argatroban
Lead sponsor: University Hospital Ostrava
Sponsor class: OTHER
First posted: 2023-09-15
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients on VV (veno-venous) ECMO on anticoagulation with Argatroban or heparin.

Brief summary: 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.

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.

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

Primary outcomes:
measure: Comparison of aPTT values with anti-IIa and Argatroban dose in patients on VV ECMO
timeFrame: up to 2 weeks
measure: Comparison of apt and anti-Xa values and heparin dose in patients on VV ECMO
timeFrame: up to 2 weeks
Secondary outcomes:
measure: Frequency and severity of bleeding complications
timeFrame: up to 2 weeks
measure: Frequency and severity of thrombotic complications
timeFrame: up to 2 weeks
measure: Consumption of blood products (in ml)
timeFrame: up to 2 weeks
Other outcomes:
Locations:
city: Ostrava
country: Czechia
facility: University Hospital Ostrava
state: Moravian-Silesian Region
Study officials:
affiliation: University Hospital Ostrava
name: Filip Burša, MD, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Seelhammer TG, Plack D, Lal A, Nabzdyk CGS. COVID-19 and ECMO: An Unhappy Marriage of Endothelial Dysfunction and Hemostatic Derangements. J Cardiothorac Vasc Anesth. 2020 Dec;34(12):3193-3196. doi: 10.1053/j.jvca.2020.09.132. Epub 2020 Oct 2. No abstract available.
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