Heart Failure, Pneumonia
Conditions
Keywords
ECMO, Pneumonia, Heart failure, Anticoagulation
Brief summary
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.
Detailed description
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.
Interventions
DRUGLow anticoagulation dose of argatroban and enoxaparin during ECMO
Study subjects in this group will receive low anticoagulation dose of argatroban and enoxaparin during ECMO
DRUGStandard anticoagulation dose of argatroban and enoxaparin during ECMO
Study subjects in this group will receive standard anticoagulation dose of argatroban and enoxaparin during ECMO
Sponsors
University Hospital Ostrava
University Hospital, Motol
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
No masking will be used in the study
Intervention model description
The study subjects will be enrolled in two parallel groups.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Czechia
Contacts
CONTACTJiří Hynčica
PRINCIPAL_INVESTIGATORFilip Burša, MD,Ph.D.,EDEC
University Hospital Ostrava
Outcome results
None listed