Xenon for Neuroprotection During Post-Cardiac Arrest Syndrome in Comatose Survivors of an Out of Hospital Cardiac Arrest
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Xenon.
- Who it may be relevant to
- Registry conditions: Post-Cardiac Arrest Syndrome. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
XePOHCAS - Xenon by Inhalation for Post Out of Hospital Cardiac Arrest Syndrome
Overview
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 product Xenon
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.
Primary outcome measures
- functional outcome: degree of functional independence measured using a modified Rankin Scale (mRS) [Time frame: 30 days after the cardiac arrest]
Secondary outcome measures (1)
- survival: number of survivors [Time frame: 30 days after the cardiac arrest]
Eligibility criteria
Inclusion criteria
- Age at least 18 years but less than or equal to 80 years
- Presumed cardiac cause of arrest
- Sustained (>20 minutes) spontaneous circulation upon arrival in the emergency department
- No response to verbal commands on arrival to emergency department and prior to randomization (Glasgow Coma Scale score of <8)
- Attending decision that patient is eligible for TTM
Exclusion criteria
- Written do not attempt resuscitation reported to providers before randomization
- Traumatic etiology of arrest, defined as concomitant blunt, penetrating, or burn-related injury, or uncontrolled bleeding or exsanguination
- Suspected or known stroke or intracranial hemorrhage
- Unwitnessed cardiac arrest
- No-flow (cardiac arrest to initiation of cardiopulmonary resuscitation/defibrillation) time of >10 minutes
- Sustained restoration of spontaneous circulation (ROSC) greater than 30- minutes post-arrest
- Interval from arrival at the emergency department to randomization for intervention of >4 hours.
- Hypothermia (<30°C core temperature)
- Bed-bound prior to cardiac arrest
- Unconsciousness before cardiac arrest (cerebral trauma, spontaneous cerebral hemorrhage, intoxication etc.)
- Coagulopathy
- Systolic arterial pressure <80 mmHg or mean arterial pressure <60 mmHg lasting more than 30 minutes after ROSC
- Known pregnancy
- Have received an investigational drug, device, or biologic product within 30-days
- Known terminal phase of chronic illness
- Hypoxemia (SaO2 <85%) for >15 minutes after ROSC
- Inability to maintain SaO2 >90% on an FiO2 of 50%
- 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
- Logistically impossible to provide intervention
- Have any condition that would impact the evaluation of modified Rankin Scale (mRS)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 8 centers
- Hartford Hospital — Hartford
- University of Florida — Gainesville
- Memorial Hospital at Gulfport — Gulfport
- University Nebraska Medical Center — Omaha
- University at Buffalo — Buffalo
- Wexner Medical Center, Ohio State University — Columbus
- Baptist Memorial Hospital, Baptist Clinical Research Institute — Memphis
- Houston Methodist Research Institute — Houston
Denmark · 2 centers
- Aalborg University Hospital — Aalborg
- University Hospital, Rigshospitalet, Blegdamsvej 9 — Copenhagen
Publications
- 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 Da PMID 26978207
- 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. PMID 33769417
Identifiers
NCT: NCT03176186 · XePOHCAS Ph III