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

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ClinicalTrials.gov Identifier: NCT03176186
Recruitment Status : Recruiting
First Posted : June 5, 2017
Last Update Posted : March 8, 2019
Sponsor:
Information provided by (Responsible Party):
NeuroproteXeon, Inc.

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).

Condition or disease Intervention/treatment Phase
Post-Cardiac Arrest Syndrome Combination Product: Xenon Phase 3

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).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1436 participants
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
Actual Study Start Date : December 20, 2018
Estimated Primary Completion Date : October 15, 2020
Estimated Study Completion Date : December 15, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Xenon

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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 :
  1. survival: number of survivors [ Time Frame: 30 days after the cardiac arrest ]
    The number of survivors will be measured



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03176186


Contacts
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Contact: Bill Stoll 7163327200 ext 134 bill.stoll@npxe.com
Contact: Bill Stoll 7164748572 bill.stoll@npxe.com

Locations
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United States, Connecticut
Hartford Hospital Recruiting
Hartford, Connecticut, United States, 06102
Contact: William Roman       William.Roman@hhchealth.org   
Principal Investigator: Antonio Fernandez, MD         
United States, Florida
University of Florida Active, not recruiting
Gainesville, Florida, United States, 32611
United States, Mississippi
Memorial Hospital at Gulfport Recruiting
Gulfport, Mississippi, United States, 39503
Contact: Brandy Williams    228-575-2480    bwilliams@mhg.com   
Contact: Katherine F. Green, BSN, RN    228-575-2518    kgreen@mhg.com   
Principal Investigator: Joseph R. Bosarge, M.D.         
United States, Nebraska
University Nebraska Medical Center Recruiting
Omaha, Nebraska, United States, 68198
Contact: Lace D Sindt, BS       lace.sindt@unmc.edu   
Principal Investigator: James N Sullivan, MD         
United States, New York
University at Buffalo Recruiting
Buffalo, New York, United States, 14203
Contact: Robin M. Stein, RN, BSN    716-888-4859    rmstein3@buffalo.edu   
Principal Investigator: Vijay Iyer, MD         
United States, Ohio
Wexner Medical Center, Ohio State University Recruiting
Columbus, Ohio, United States, 43210
Contact: January Kim, BS    614-293-3559    January.Kim@osumc.edu   
Principal Investigator: Uribe Alberto, MD         
United States, Tennessee
Baptist Memorial Hospital, Baptist Clinical Research Institute Recruiting
Memphis, Tennessee, United States, 38120
Contact: Mildred Jenkins       Mildred.Jenkins@BMHCC.org   
Principal Investigator: Patricia Hopkins         
United States, Texas
Houston Methodist Research Institute Recruiting
Houston, Texas, United States, 77030
Contact: Digant Jariwala       djariwala@houstonmethodist.org   
Principal Investigator: Janice Zimmerman, MD         
Denmark
Aalborg University Hospital Active, not recruiting
Aalborg, Denmark
University Hospital, Rigshospitalet, Blegdamsvej 9 Active, not recruiting
Copenhagen, Denmark
Sponsors and Collaborators
NeuroproteXeon, Inc.
Investigators
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Study Director: Myron B Peterson, M.D cro
Study Director: David Franklin, M.B., B.Ch., cro

Additional Information:
Publications:
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Responsible Party: NeuroproteXeon, Inc.
ClinicalTrials.gov Identifier: NCT03176186     History of Changes
Other Study ID Numbers: XePOHCAS Ph III
First Posted: June 5, 2017    Key Record Dates
Last Update Posted: March 8, 2019
Last Verified: March 2019
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.

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