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

This study is not yet open for participant recruitment.
Verified June 2017 by NeuroproteXeon, Inc.
Sponsor:
ClinicalTrials.gov Identifier:
NCT03176186
First Posted: June 5, 2017
Last Update Posted: June 5, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
NeuroproteXeon, Inc.
  Purpose
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).

Condition Intervention Phase
Post-Cardiac Arrest Syndrome Combination Product: Xenon Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: XePOHCAS - Xenon by Inhalation for Post Out of Hospital Cardiac Arrest Syndrome

Resource links provided by NLM:


Further study details as provided by NeuroproteXeon, Inc.:

Primary Outcome Measures:
  • functional outcome: degree of functional independence measured using a modified Rankin Scale (mRS) [ Time Frame: 30 days after the cardiac arrest ]
    The degree of functional independence will be measured using a modified Rankin Scale (mRS)


Secondary Outcome Measures:
  • survival: number of survivors [ Time Frame: 30 days after the cardiac arrest ]
    The number of survivors will be measured


Estimated Enrollment: 1436
Anticipated Study Start Date: October 15, 2017
Estimated Study Completion Date: October 15, 2019
Estimated Primary Completion Date: July 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: TH/TTM
Protocol-directed standard of care (including TH/TTM) dictated by the 2015 guidelines for Post-Cardiac Arrest Care from the American Heart Association and the European Resuscitation Council. Mechanical Ventilation delivered by individual site-sanctioned ventilator.
Active Comparator: TH/TTM plus Xenon
50% xenon gas in addition to standard of care, including therapeutic hypothermia/targeted temperature management (TH/TTM).
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.
Other Name: XENEX

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Additional Information:
Publications:
Responsible Party: NeuroproteXeon, Inc.
ClinicalTrials.gov Identifier: NCT03176186     History of Changes
Other Study ID Numbers: XePOHCAS Ph III
First Submitted: December 5, 2016
First Posted: June 5, 2017
Last Update Posted: June 5, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Authorized representatives of the SITE OF STUDY CONDUCT or other associated health care providers as authorized.

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes

Keywords provided by NeuroproteXeon, Inc.:
ischemic-reperfusion injury
out of hospital cardiac arrest

Additional relevant MeSH terms:
Syndrome
Heart Arrest
Out-of-Hospital Cardiac Arrest
Disease
Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Xenon
Anesthetics, Inhalation
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs