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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).
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TH/TTM | No Intervention | 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. | |
| TH/TTM plus Xenon | Active Comparator | 50% xenon gas in addition to standard of care, including therapeutic hypothermia/targeted temperature management (TH/TTM). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Xenon | Combination Product | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| survival: number of survivors | The number of survivors will be measured | 30 days after the cardiac arrest |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trial Support at Invero Pharma | Contact | (862) 800-7788 | 801 | dstefanelli@inveropharma.com |
| Regulatory Affairs at Invero Pharma | Contact | (862) 800-7788 | 803 | mnapoletano@inverohealth.com |
| Name | Affiliation | Role |
|---|---|---|
| Steffen Stuerzebecher, M.D. | CMO Invero Pharma | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hartford Hospital | Hartford | Connecticut | 06102 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26978207 | Background | 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. | |
| 33769417 |
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Authorized representatives of the SITE OF STUDY CONDUCT or other associated health care providers as authorized.
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|
|
| University of Florida | Gainesville | Florida | 32611 | United States |
| Memorial Hospital at Gulfport | Gulfport | Mississippi | 39503 | United States |
|
| University Nebraska Medical Center | Omaha | Nebraska | 68198 | United States |
|
| University at Buffalo | Buffalo | New York | 14203 | United States |
|
| Wexner Medical Center, Ohio State University | Columbus | Ohio | 43210 | United States |
|
| Baptist Memorial Hospital, Baptist Clinical Research Institute | Memphis | Tennessee | 38120 | United States |
|
| Houston Methodist Research Institute | Houston | Texas | 77030 | United States |
|
| Aalborg University Hospital | Aalborg | Denmark |
| University Hospital, Rigshospitalet, Blegdamsvej 9 | Copenhagen | Denmark |
| Derived |
| 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. |
| ID | Term |
|---|---|
| D000080942 | Post-Cardiac Arrest Syndrome |
| D058687 | Out-of-Hospital Cardiac Arrest |
| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D015427 | Reperfusion Injury |
| D014652 | Vascular Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006323 | Heart Arrest |
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| ID | Term |
|---|---|
| D014978 | Xenon |
| ID | Term |
|---|---|
| D005741 | Noble Gases |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D005740 | Gases |
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