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

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

Study Description

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).

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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

Eligibility Criteria

• 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)

Contacts and Locations

Contacts

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

Contact: Bill Stoll; 7164748572; bill.stoll@npxe.com

Locations

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

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

More Information

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 Damage in Comatose Survivors of Out-of-Hospital Cardiac Arrest: A Randomized Clinical Trial. JAMA. 2016 Mar 15;315(11):1120-8. doi: 10.1001/jama.2016.1933.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: NeuroproteXeon, Inc.
• ClinicalTrials.gov Identifier: NCT03176186
• Other Study ID Numbers: XePOHCAS Ph III
• First Posted: June 5, 2017
• 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.

• 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:

Post-Cardiac Arrest Syndrome; Heart Arrest; Out-of-Hospital Cardiac Arrest; Syndrome; Disease; Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Reperfusion Injury; Vascular Diseases; Postoperative Complications; Xenon; Anesthetics, Inhalation; Anesthetics, General; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs