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

March 6, 2019 updated by: NeuroproteXeon, Inc.

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

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Anticipated)

1436

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Denmark
      • Aalborg, Denmark
        • Active, not recruiting
        • Aalborg University Hospital
      • Copenhagen, Denmark
        • Active, not recruiting
        • University Hospital, Rigshospitalet, Blegdamsvej 9
  • United States
    • Connecticut
      • Hartford, Connecticut, United States, 06102
    • Florida
      • Gainesville, Florida, United States, 32611
        • Active, not recruiting
        • University of Florida
    • Mississippi
      • Gulfport, Mississippi, United States, 39503
        • Recruiting
        • Memorial Hospital at Gulfport
        • Contact:
        • Contact:
          • Katherine F. Green, BSN, RN
          • Phone Number: 228-575-2518
          • Email: kgreen@mhg.com
        • Principal Investigator:
          • Joseph R. Bosarge, M.D.
    • Nebraska
      • Omaha, Nebraska, United States, 68198
        • Recruiting
        • University Nebraska Medical Center
        • Contact:
        • Principal Investigator:
          • James N Sullivan, MD
    • New York
      • Buffalo, New York, United States, 14203
        • Recruiting
        • University at Buffalo
        • Contact:
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • Wexner Medical Center, Ohio State University
        • Contact:
        • Principal Investigator:
          • Uribe Alberto, MD
    • Tennessee
      • Memphis, Tennessee, United States, 38120
        • Recruiting
        • Baptist Memorial Hospital, Baptist Clinical Research Institute
        • Contact:
        • Principal Investigator:
          • Patricia Hopkins
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • Houston Methodist Research Institute
        • Contact:
        • Principal Investigator:
          • Janice Zimmerman, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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 Names:
  • XENEX

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
30 days after the cardiac arrest

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
survival: number of survivors
Time Frame: 30 days after the cardiac arrest
The number of survivors will be measured
30 days after the cardiac arrest

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NeuroproteXeon, Inc.

Investigators

  • Study Director: Myron B Peterson, M.D, cro
  • Study Director: David Franklin, M.B., B.Ch.,, cro

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 20, 2018

Primary Completion (ANTICIPATED)

October 15, 2020

Study Completion (ANTICIPATED)

December 15, 2020

Study Registration Dates

First Submitted

December 5, 2016

First Submitted That Met QC Criteria

June 2, 2017

First Posted (ACTUAL)

June 5, 2017

Study Record Updates

Last Update Posted (ACTUAL)

March 8, 2019

Last Update Submitted That Met QC Criteria

March 6, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XePOHCAS Ph III

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Authorized representatives of the SITE OF STUDY CONDUCT or other associated health care providers as authorized.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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