The standard and most common therapy is anticoagulation with heparin according to activated partial thromboplastin time (aPTT) during extracorporeal membrane oxygenation (ECMO) support. The study will focus on evaluating the efficacy and safety of new anticoagulants on ECMO, namely argatroban and enoxaparin in lower doses controlled according to targeted antiIIa and antiXa markers.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
200
Study subjects in this group will receive low anticoagulation dose of argatroban and enoxaparin during ECMO
Study subjects in this group will receive standard anticoagulation dose of argatroban and enoxaparin during ECMO
University Hospital Ostrava
Ostrava, Moravian-Silesian Region, Czechia
University Hospital Motol
Prague, Czechia
Safety of bleeding complications
Bleeding Academic Research Consortium (BARC) score will be used to assess bleeding complication.
Time frame: During ECMO, up to 4 weeks
Safety of thrombotic complications
ECMO pressures (e.g. oxygenator changes) will be used to assess thrombotic complications
Time frame: During ECMO, up to 4 weeks
Mortality
Hospital mortality and 6-month mortality will be assessed
Time frame: 6 months
Cerebral Performance Category (CPC) score
Cerebral Performance Category (CPC) score will be assessed on the 30th day after ECMO initiation
Time frame: 30 days
Quality of Life questionnaires score - EQ-5D-5L
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).
Time frame: 6 months
Quality of Life questionnaires score - SF36
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.
Time frame: 6 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.