Monitoring Anticoagulation in Patients on ECMO for Severe Lung Failure

Study Overview
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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.

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.

Official Title
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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.

Conditions
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ARDS, COVID-19

Intervention / Treatment
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* Drug: Argatroban Injection
* Drug: Heparin


Participation Criteria
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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 Exclusion Criteria: - age under 18 years

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Argatroban anticoagulation<br>Study subjects in this group will receive Argatroban anticoagulation. | Drug: Argatroban Injection<br>* Argatroban will be administered to the study subjects in this group in order to achieve anticoagulation.<br>|
| Heparin anticoagulation<br>Study subjects in this group will receive Heparin anticoagulation. | Drug: Heparin<br>* Heparin will be administered to the study subjects in this group in order to achieve anticoagulation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of aPTT values with anti-IIa and Argatroban dose in patients on VV ECMO | Comparison of correlation of aPTT and anti-IIa with dynamics of D dimer, FDP (fibrin degradation product) and acute phase reactants of ferritin, CRP (C-reactive protein) Correlation of bleeding complications with aPTT, anti-IIa, platelets | up to 2 weeks | 
| Comparison of apt and anti-Xa values and heparin dose in patients on VV ECMO | Comparison of correlation of aPTT and anti-Xa with dynamics of D dimer, FDP and acute phase reactants of ferritin, CRP | up to 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency and severity of bleeding complications | Comparison of frequency and severity of bleeding complications in patients on anticoagulation with Argatroban and heparin | up to 2 weeks | 
| Frequency and severity of thrombotic complications | Comparison of frequency and severity of thrombotic complications in patients anticoagulated with Argatroban and heparin | up to 2 weeks | 
| Consumption of blood products (in ml) | The consumption of blood products (volume in ml) in patients on Argatroban and heparin | up to 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ECMO, ARDS (acute respiratory distress syndrome), anticoagulation, thrombotic complications, LMWH (low-molecular-weight heparin), Argatroban