Xenon for Neuroprotection During Post-Cardiac Arrest Syndrome in Comatose Survivors of an Out of Hospital Cardiac Arrest

Официальное название

XePOHCAS - Xenon by Inhalation for Post Out of Hospital Cardiac Arrest Syndrome

Обзор

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).

Подробное описание

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).

Вмешательства

• Комбинированный продукт 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.

Первичные конечные точки

• functional outcome: degree of functional independence measured using a modified Rankin Scale (mRS) [Срок оценки: 30 days after the cardiac arrest]

Вторичные конечные точки (1)

• survival: number of survivors [Срок оценки: 30 days after the cardiac arrest]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 8 центров

• 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

Дания · 2 центра

• Aalborg University Hospital — Aalborg
• University Hospital, Rigshospitalet, Blegdamsvej 9 — Copenhagen

Публикации

• 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

Идентификаторы

NCT: NCT03176186 · XePOHCAS Ph III

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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