Post-Cardiac Arrest Syndrome
Conditions
Keywords
ischemic-reperfusion injury, out of hospital cardiac arrest
Brief summary
XePOHCAS: Prospective, randomized, multicenter interventional trial in adult subjects with out-of-hospital cardiac arrest comparing treatment with standard-of-care post-cardiac arrest intensive care (which is targeted temperature management \[TTM\]) to xenon by inhalation plus standard-of-care post-cardiac arrest intensive care (including TTM).
Detailed description
XePOHCAS: Primary Objective: To evaluate whether there is a difference in functional outcome with xenon 50% and oxygen during targeted temperature management (TTM) compared with similar oxygen content in air during TTM in comatose subjects with sustained restoration of spontaneous circulation (ROSC) within 30 minutes after out-of-hospital cardiac arrest (OHCA). Secondary Objective: To evaluate whether there is a difference in survival with xenon 50% and oxygen during targeted temperature management (TTM) compared with similar oxygen content in air during TTM in comatose subjects with sustained restoration of spontaneous circulation (ROSC) within 30 minutes after out-of-hospital cardiac arrest (OHCA).
Interventions
COMBINATION_PRODUCTXenon
50% xenon by inhalation, delivered by customized xenon delivery system, that includes a ventilator, for the 24h period of TH/TTM. The inhalation therapy is provided in combination with protocol-directed Post-Cardiac Arrest Care dictated by the 2015 guidelines from the American Heart Association and the European Resuscitation Council.
Sponsors
Invero Pharma, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Age at least 18 years but less than or equal to 80 years 2. Presumed cardiac cause of arrest 3. Sustained (\>20 minutes) spontaneous circulation upon arrival in the emergency department 4. No response to verbal commands on arrival to emergency department and prior to randomization (Glasgow Coma Scale score of \<8) 5. Attending decision that patient is eligible for TTM
Exclusion criteria
1. Written do not attempt resuscitation reported to providers before randomization 2. Traumatic etiology of arrest, defined as concomitant blunt, penetrating, or burn-related injury, or uncontrolled bleeding or exsanguination 3. Suspected or known stroke or intracranial hemorrhage 4. Unwitnessed cardiac arrest 5. No-flow (cardiac arrest to initiation of cardiopulmonary resuscitation/defibrillation) time of \>10 minutes 6. Sustained restoration of spontaneous circulation (ROSC) greater than 30- minutes post-arrest 7. Interval from arrival at the emergency department to randomization for intervention of \>4 hours. 8. Hypothermia (\<30°C core temperature) 9. Bed-bound prior to cardiac arrest 10. Unconsciousness before cardiac arrest (cerebral trauma, spontaneous cerebral hemorrhage, intoxication etc.) 11. Coagulopathy 12. Systolic arterial pressure \<80 mmHg or mean arterial pressure \<60 mmHg lasting more than 30 minutes after ROSC 13. Known pregnancy 14. Have received an investigational drug, device, or biologic product within 30-days 15. Known terminal phase of chronic illness 16. Hypoxemia (SaO2 \<85%) for \>15 minutes after ROSC 17. Inability to maintain SaO2 \>90% on an FiO2 of 50% 18. Having any other clinically significant laboratory abnormality, medical condition (such as intrinsic liver disease or severe chronic obstructive pulmonary disease), or social circumstance that, in the investigator's opinion, makes it inappropriate for the patient to participate in this clinical trial 19. Logistically impossible to provide intervention 20. Have any condition that would impact the evaluation of modified Rankin Scale (mRS)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| functional outcome: degree of functional independence measured using a modified Rankin Scale (mRS) | 30 days after the cardiac arrest | The degree of functional independence will be measured using a modified Rankin Scale (mRS) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| survival: number of survivors | 30 days after the cardiac arrest | The number of survivors will be measured |
Countries
Denmark, United States
Contacts
Primary ContactClinical Trial Support at Invero Pharma
Backup ContactRegulatory Affairs at Invero Pharma
Outcome results
None listed