DRKS00033769
Recruiting
Not Applicable
nderstanding Extracorporal Membrane Oxygenation Induced Coaguloapathy – A Prospective Cohort Study in the Intensive Care Unit (EXTRICATE) - EXTRICATE
niversität Witten/Herdecke & Klinik Köln Merheim0 sites50 target enrollmentFebruary 29, 2024
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- In VV-ECMO patients with severe ARDS
- Sponsor
- niversität Witten/Herdecke & Klinik Köln Merheim
- Enrollment
- 50
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •For VV\-ECMO analogous to previous studies:
- •\- severe ARDS according to the Berlin criteria
- •\- PaO2:FiO2 ratio \<50 mmHg for \>3 hours despite optimization of mechanical ventilation \[FiO2 \=80%, tidal volume \= 6 ml per kg of ideal body weight and positive end\-expiratory pressure (PEEP) \=10 cm H2O) and despite the use of adjuvant therapeutic measures (e.g. inhaled nitric oxide therapy, recruitment maneuver, ventilation in prone position)]
- •\- PaO2:FIO2 ratio \<80 mmHg for \>6 hours despite the aforementioned measures
- •\- Arterial pH \<7\.25 with PaCO2 \>60 mmHg for \>6 hours under ventilator settings with a plateau pressure \=32 cm H2O
- •For VA\-ECMO analogous to previous studies:
- •\- Observed collapse with no\-flow time \< 5 min and low\-flow time \< 90 min on arrival in the cardiac catheter
- •\- Initial and sustained defibrillable rhythm or non\-defibrillable rhythm in case of tamponade or pulmonary artery embolism (exception: accidental hypothermia or intoxication)
Exclusion Criteria
- •1\. pregnancy
- •2\. patient moribund or with Simplified Acute Physiology Score value \>90
- •3\. underlying malignancy with life expectancy \< 5 years
- •4\. irreversible neurological damage
- •5\. decision to limit therapy
- •6\. ventilation for longer than 7 days (for vv\-ECMO)
- •7\. chronic lung disease and chronic respiratory respiratory insufficiency with home oxygen therapy (for vv\-ECMO)
- •8\. history of heparin\-induced thrombocytopenia or other contraindication to heparin
- •9\. hereditary thrombophilia or hemophilia
- •10\. therapeutic anticoagulation or dual platelet inhibition
Outcomes
Primary Outcomes
Not specified
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