A Phase 2 interventional study of Low anticoagulation dose of argatroban and enoxaparin during ECMO and Standard anticoagulation dose of argatroban and enoxaparin during ECMO in Pneumonia and Heart Failure, sponsored by University Hospital Ostrava. Not yet recruiting at 2 sites in Czechia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-02.
Sponsored by University Hospital Ostrava · Phase 2, Interventional, and Treatment
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.
1,564 studies on the registry are indexed under Pneumonia; 265 are open to participants now.
This study's planned enrollment of 200 is above the median of 129 across 975 interventional studies indexed under Pneumonia.
Browse Pneumonia studies →University Hospital Ostrava is the lead sponsor of 148 studies on the registry; 50 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Study subjects in this group will receive low anticoagulation dose of argatroban and enoxaparin during ECMO.
Drug: 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.
Drug: Standard anticoagulation dose of argatroban and enoxaparin during ECMO
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
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
Plan to share: No — There is no plan to make individual participant data available to other researchers. The data may be provided upon reasonable request.
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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