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

Post-Cardiac Arrest Syndrome Clinical Trial

— XePOHCAS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03176186
• Other study ID #: XePOHCAS Ph III
• Status: Recruiting
• Phase: Phase 3
• Start date: December 20, 2018
• Est. completion date: December 15, 2020

Study information

• Verified date: March 2019
• Source: NeuroproteXeon, Inc.
• Contact: Bill Stoll
• Phone: 7163327200
• Email: bill.stoll[@]npxe.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1436
• Est. completion date: December 15, 2020
• Est. primary completion date: October 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Heart Arrest
• Out-of-Hospital Cardiac Arrest
• Post-Cardiac Arrest Syndrome
• Syndrome

Intervention

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.

Locations

Country	Name	City	State
Denmark	Aalborg University Hospital	Aalborg
Denmark	University Hospital, Rigshospitalet, Blegdamsvej 9	Copenhagen
United States	University at Buffalo	Buffalo	New York
United States	Wexner Medical Center, Ohio State University	Columbus	Ohio
United States	University of Florida	Gainesville	Florida
United States	Memorial Hospital at Gulfport	Gulfport	Mississippi
United States	Hartford Hospital	Hartford	Connecticut
United States	Houston Methodist Research Institute	Houston	Texas
United States	Baptist Memorial Hospital, Baptist Clinical Research Institute	Memphis	Tennessee
United States	University Nebraska Medical Center	Omaha	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
NeuroproteXeon, Inc.

Countries where clinical trial is conducted

United States,  Denmark, 

References & Publications (1)

Laitio R, Hynninen M, Arola O, Virtanen S, Parkkola R, Saunavaara J, Roine RO, Grönlund J, Ylikoski E, Wennervirta J, Bäcklund M, Silvasti P, Nukarinen E, Tiainen M, Saraste A, Pietilä 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	30 days after the cardiac arrest
Secondary	survival: number of survivors	The number of survivors will be measured	30 days after the cardiac arrest

External Links

•   Phase 2 RCT that forms the basis for this clinical trial