Status:
UNKNOWN
Phase 1 Study of HBN-1
Lead Sponsor:
Hibernaid, Inc
Conditions:
Cardiac Arrest
Eligibility:
All Genders
40-80 years
Phase:
PHASE1
Brief Summary
Phase 1 First-in Human randomized, open-label, active control standard of care study of the safety of HBN-1 administered as pharmacologically induced hypothermia as an adjunct to standard of care targ...
Detailed Description
Phase 1 First-in Human randomized, open-label, active control standard of care study of the safety of HBN-1 administered as pharmacologically induced hypothermia as an adjunct to standard of care targ...
Eligibility Criteria
Inclusion
- Age 40 to 80 years, inclusive
- Documented diagnosis of OHCA with ventricular tachycardia/fibrillation, asystole or pulseless electrical activity
- Return of spontaneous circulation within 50 minutes of the event
- FOUR Motor Score \<4
- Maximum estimated weight not to exceed 100 kg
Exclusion
- Return of spontaneous circulation \>8 hours
- Known history of prior cardiac arrest, alcohol, or substance abuse or dependence
- Presumed etiology of cardiac arrest is trauma, hemorrhage, or sepsis
- Comfort measures only or anticipated withdrawal of life-support within 24 hours
- Is within a protected population group (eg, pregnant or breastfeeding or incarcerated persons)
- Has history or evidence of significant hepatic dysfunction (Sequential Organ Failure Assessment Hepatic score \>2)
- Any other condition, that in the opinion of the investigator, would preclude the subject from being a suitable candidate, e.g. end-stage chronic illness with no reasonable expectation of survival to hospital discharge
- Is able to obey to verbal commands
- Is receiving IV vasopressin or lidocaine hydrochloride
Key Trial Info
Start Date :
October 30 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2020
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT04094857
Start Date
October 30 2019
End Date
December 31 2020
Last Update
October 7 2019
Active Locations (2)
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1
Maine Medical Center
Portland, Maine, United States, 04103
2
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15261