Clinical trial NCT03176186: Xenon for Neuroprotection During Post-Cardiac Arrest Syndrome in Comatose Survivors of an Out of Hospital Cardiac Arrest
Official title: XePOHCAS - Xenon by Inhalation for Post Out of Hospital Cardiac Arrest Syndrome
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Post-Cardiac Arrest Syndrome
Keywords: ischemic-reperfusion injury
out of hospital cardiac arrest
Lead sponsor: Invero Pharma, Inc.
Sponsor class: INDUSTRY
First posted: 2017-06-05
Enrollment: 1436
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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)

Primary outcomes:
measure: functional outcome: degree of functional independence measured using a modified Rankin Scale (mRS)
timeFrame: 30 days after the cardiac arrest
Secondary outcomes:
measure: survival: number of survivors
timeFrame: 30 days after the cardiac arrest
Other outcomes:
Locations:
city: Hartford
country: United States
facility: Hartford Hospital
state: Connecticut
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Gulfport
country: United States
facility: Memorial Hospital at Gulfport
state: Mississippi
city: Omaha
country: United States
facility: University Nebraska Medical Center
state: Nebraska
city: Buffalo
country: United States
facility: University at Buffalo
state: New York
city: Columbus
country: United States
facility: Wexner Medical Center, Ohio State University
state: Ohio
city: Memphis
country: United States
facility: Baptist Memorial Hospital, Baptist Clinical Research Institute
state: Tennessee
city: Houston
country: United States
facility: Houston Methodist Research Institute
state: Texas
city: Aalborg
country: Denmark
facility: Aalborg University Hospital
city: Copenhagen
country: Denmark
facility: University Hospital, Rigshospitalet, Blegdamsvej 9
Study officials:
affiliation: CMO Invero Pharma
name: Steffen Stuerzebecher, M.D.
role: STUDY_DIRECTOR
References:
citation: Laitio R, Hynninen M, Arola O, Virtanen S, Parkkola R, Saunavaara J, Roine RO, Gronlund J, Ylikoski E, Wennervirta J, Backlund M, Silvasti P, Nukarinen E, Tiainen M, Saraste A, Pietila M, Airaksinen J, Valanne L, Martola J, Silvennoinen H, Scheinin H, Harjola VP, Niiranen J, Korpi K, Varpula M, Inkinen O, Olkkola KT, Maze M, Vahlberg T, Laitio T. Effect of Inhaled Xenon on Cerebral White Matter Damage in Comatose Survivors of Out-of-Hospital Cardiac Arrest: A Randomized Clinical Trial. JAMA. 2016 Mar 15;315(11):1120-8. doi: 10.1001/jama.2016.1933.
citation: Magliocca A, Fries M. Inhaled gases as novel neuroprotective therapies in the postcardiac arrest period. Curr Opin Crit Care. 2021 Jun 1;27(3):255-260. doi: 10.1097/MCC.0000000000000820.