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

Primary Purpose

Post-Cardiac Arrest Syndrome

Status

Unknown status

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Xenon

About this trial

This is an interventional treatment trial for Post-Cardiac Arrest Syndrome focused on measuring ischemic-reperfusion injury, out of hospital cardiac arrest

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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)

Sites / Locations

Hartford HospitalRecruiting
University of Florida
Memorial Hospital at GulfportRecruiting
University Nebraska Medical CenterRecruiting
University at BuffaloRecruiting
Wexner Medical Center, Ohio State UniversityRecruiting
Baptist Memorial Hospital, Baptist Clinical Research InstituteRecruiting
Houston Methodist Research InstituteRecruiting
Aalborg University Hospital
University Hospital, Rigshospitalet, Blegdamsvej 9

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

TH/TTM

TH/TTM plus Xenon

Arm Description

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.

50% xenon gas in addition to standard of care, including therapeutic hypothermia/targeted temperature management (TH/TTM).

Outcomes

Primary Outcome Measures

functional outcome: degree of functional independence measured using a modified Rankin Scale (mRS)

The degree of functional independence will be measured using a modified Rankin Scale (mRS)

Secondary Outcome Measures

survival: number of survivors

The number of survivors will be measured

Full Information

NCT ID

NCT03176186

First Posted

December 5, 2016

Last Updated

March 6, 2019

Sponsor

NeuroproteXeon, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT03176186

Brief Title

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

Acronym

XePOHCAS

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2019

Overall Recruitment Status

Unknown status

Study Start Date

December 20, 2018 (Actual)

Primary Completion Date

October 15, 2020 (Anticipated)

Study Completion Date

December 15, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

NeuroproteXeon, Inc.

4. Oversight

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

Data Monitoring Committee

Yes

5. 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).

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Post-Cardiac Arrest Syndrome

Keywords

ischemic-reperfusion injury, out of hospital cardiac arrest

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

1436 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

TH/TTM

Arm Type

No Intervention

Arm Description

Arm Title

TH/TTM plus Xenon

Arm Type

Active Comparator

Arm Description

50% xenon gas in addition to standard of care, including therapeutic hypothermia/targeted temperature management (TH/TTM).

Intervention Type

Combination Product

Intervention Name(s)

Xenon

Other Intervention Name(s)

XENEX

Intervention Description

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.

Primary Outcome Measure Information:

Title

functional outcome: degree of functional independence measured using a modified Rankin Scale (mRS)

Description

The degree of functional independence will be measured using a modified Rankin Scale (mRS)

Time Frame

30 days after the cardiac arrest

Secondary Outcome Measure Information:

Title

survival: number of survivors

Description

The number of survivors will be measured

Time Frame

30 days after the cardiac arrest

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Bill Stoll

Phone

7163327200

Ext

134

bill.stoll@npxe.com

First Name & Middle Initial & Last Name or Official Title & Degree

Bill Stoll

Phone

7164748572

bill.stoll@npxe.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Myron B Peterson, M.D

Organizational Affiliation

cro

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

David Franklin, M.B., B.Ch.,

Organizational Affiliation

cro

Official's Role

Study Director

Facility Information:

Facility Name

Hartford Hospital

City

Hartford

State/Province

Connecticut

ZIP/Postal Code

06102

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

William Roman

William.Roman@hhchealth.org

First Name & Middle Initial & Last Name & Degree

Antonio Fernandez, MD

Facility Name

University of Florida

City

Gainesville

State/Province

Florida

ZIP/Postal Code

32611

Country

United States

Individual Site Status

Active, not recruiting

Facility Name

Memorial Hospital at Gulfport

City

Gulfport

State/Province

Mississippi

ZIP/Postal Code

39503

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Brandy Williams

Phone

228-575-2480

bwilliams@mhg.com

First Name & Middle Initial & Last Name & Degree

Katherine F. Green, BSN, RN

Phone

228-575-2518

kgreen@mhg.com

First Name & Middle Initial & Last Name & Degree

Joseph R. Bosarge, M.D.

Facility Name

University Nebraska Medical Center

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68198

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Lace D Sindt, BS

lace.sindt@unmc.edu

First Name & Middle Initial & Last Name & Degree

James N Sullivan, MD

Facility Name

University at Buffalo

City

Buffalo

State/Province

New York

ZIP/Postal Code

14203

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Robin M. Stein, RN, BSN

Phone

716-888-4859

rmstein3@buffalo.edu

First Name & Middle Initial & Last Name & Degree

Vijay Iyer, MD

Facility Name

Wexner Medical Center, Ohio State University

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43210

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

January Kim, BS

Phone

614-293-3559

January.Kim@osumc.edu

First Name & Middle Initial & Last Name & Degree

Uribe Alberto, MD

Facility Name

Baptist Memorial Hospital, Baptist Clinical Research Institute

City

Memphis

State/Province

Tennessee

ZIP/Postal Code

38120

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Mildred Jenkins

Mildred.Jenkins@BMHCC.org

First Name & Middle Initial & Last Name & Degree

Patricia Hopkins

Facility Name

Houston Methodist Research Institute

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Digant Jariwala

djariwala@houstonmethodist.org

First Name & Middle Initial & Last Name & Degree

Janice Zimmerman, MD

Facility Name

Aalborg University Hospital

City

Aalborg

Country

Denmark

Individual Site Status

Active, not recruiting

Facility Name

University Hospital, Rigshospitalet, Blegdamsvej 9

City

Copenhagen

Country

Denmark

Individual Site Status

Active, not recruiting

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

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

Citations:

PubMed Identifier

26978207

Citation

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.

Results Reference

background

PubMed Identifier

33769417

Citation

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.

Results Reference

derived

Learn more about this trial

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

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