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| Name | Class |
|---|---|
| University Hospital, Motol | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low anticoagulation dose of argatroban and enoxaparin during ECMO | Experimental | 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 | Experimental | Study subjects in this group will receive standard anticoagulation dose of argatroban and enoxaparin during ECMO. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of bleeding complications | Bleeding Academic Research Consortium (BARC) score will be used to assess bleeding complication. | During ECMO, up to 4 weeks |
| Safety of thrombotic complications | ECMO pressures (e.g. oxygenator changes) will be used to assess thrombotic complications | During ECMO, up to 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | Hospital mortality and 6-month mortality will be assessed | 6 months |
| Cerebral Performance Category (CPC) score | Cerebral Performance Category (CPC) score will be assessed on the 30th day after ECMO initiation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jiří Hynčica | Contact | +42059737 | 2587 | jiri.hyncica@fno.cz |
| Name | Affiliation | Role |
|---|---|---|
| Filip Burša, MD,Ph.D.,EDEC | University Hospital Ostrava | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Ostrava | Ostrava | Moravian-Silesian Region | 708 52 | Czechia |
There is no plan to make individual participant data available to other researchers. The data may be provided upon reasonable request.
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The study subjects will be enrolled in two parallel groups.
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No masking will be used in the study
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| 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 |
|
| 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). | 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. | 6 months |
| University Hospital Motol | Prague | 150 00 | Czechia |
|
| ID | Term |
|---|---|
| D011014 | Pneumonia |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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