Status:
WITHDRAWN
Prehospital Non-invasive Cooling of Comatose Patients After Cardiac Arrest
Lead Sponsor:
Medical University of Vienna
Collaborating Sponsors:
Bodychillz Ltd
Conditions:
Cardiac Arrest
Postresuscitation Encephalopathy
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Single centre randomized controlled two arm clinical trial of patients after out of hospital cardiac arrest with return of spontaneous circulation. The trial objective is to investigate external cool...
Detailed Description
1 CLINICAL TRIAL PLAN 1.1 Trial Objective The objective of this outcome clinical trial is to evaluate the effectiveness and safety of ultra-early therapeutic hypothermia in cardiac arrest patients usi...
Eligibility Criteria
Inclusion
- Over 18 years of age
- Witnessed cardiac arrest
- Restoration of spontaneous circulation
- All Primary rhythms
- Cardiac arrest of presumed cardiac origin
Exclusion
- Hypothermia (\< 34 °C) on screening
- Comatose prior to cardiac arrest due to central nervous system depressant drugs
- CPC higher than 2 prior to cardiac arrest
- Known pregnancy
- Glasgow coma scale (GCS) \> 8 at screening
- Known malignancy e.g. terminal illness (pre-cardiac arrest life expectancy of \< 6 months due to underlying medical conditions or pre-existing co-morbidities.)
- Follow up unlikely to be possible
- Patients already randomized to a clinical trial
- The patient has a known history of bleeding diathesis, coagulopathy, cryoglobulinemia, sickle cell anaemia, or will refuse blood transfusions
- The patient is a vulnerable subject, for instance, a person in detention (i.e., prisoner or ward of the state)
Key Trial Info
Start Date :
February 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03829215
Start Date
February 1 2022
End Date
December 1 2022
Last Update
May 8 2025
Active Locations (1)
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1
Medical University of Vienna
Vienna, Vienna, Austria, 1090