Safety and Efficacy of Low-dose Anticoagulation With Argatroban and Enoxaparin on ECMO

This is a phase II academic clinical trial designed to evaluate the effect of argatroban and enoxaparin used to enable ECMO support in critically ill patients. The population will consist of patients hospitalised at University Hospital Ostrava and University Hospital Motol Prague. After signing the Informed Con-sent to participate in the study, treatment will be based on the patient's clinical condition and the decision of the attending physician. The study participants will be patients diagnosed with heart failure (including cardiac arrest) or pulmonary failure, adult men and women, using argatroban or enoxaparin.

• Low anticoagulation dose of argatroban and enoxaparin during ECMO (Drug): Study subjects in this group will receive low anticoagulation dose of argatroban and enoxaparin during ECMO
• Standard anticoagulation dose of argatroban and enoxaparin during ECMO (Drug): Study subjects in this group will receive standard anticoagulation dose of argatroban and enoxaparin during ECMO

Primary outcomes

• Safety of bleeding complications [During ECMO, up to 4 weeks]: Bleeding Academic Research Consortium (BARC) score will be used to assess bleeding complication.
• Safety of thrombotic complications [During ECMO, up to 4 weeks]: ECMO pressures (e.g. oxygenator changes) will be used to assess thrombotic complications

Secondary outcomes

• Mortality [6 months]: Hospital mortality and 6-month mortality will be assessed
• Cerebral Performance Category (CPC) score [30 days]: Cerebral Performance Category (CPC) score will be assessed on the 30th day after ECMO initiation
• Quality of Life questionnaires score - EQ-5D-5L [6 months]: Quality of Life will be assessed using the EQ-5D-5L questionnaire 6 months after ECMO initiation. The EQ-5D-5L questionnaire is a quick, 5-dimension preference-based tool (mobility, self-care, activities, pain, anxiety) with a visual analog scale (VAS).
• Quality of Life questionnaires score - SF36 [6 months]: Quality of Life will be assessed using the SF36 questionnaire 6 months after ECMO initiation. SF-36 is a comprehensive 36-item survey assessing eight health domains.

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* ECMO support with anticoagulation using argatroban/enoxaparin
* Age ≥ 18 years
* Obtaining informed consent in accordance with the procedure specified in the protocol

Exclusion Criteria:

* Enrolment in the lung transplant program at Motol University Hospital
* Known hypersensitivity to the components of the evaluated products
* Allergic reaction to the active ingredients of the evaluated products
* Pregnancy and breastfeeding

• Filip Burša, MD,Ph.D.,EDEC, Principal investigator, University Hospital Ostrava