Actively Recruiting
Long Term Follow-up of Cardiac Arrest Survivors Exposed to Ultra-rapid Cooling
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2026-03-24
12
Participants Needed
2
Research Sites
337 weeks
Total Duration
On this page
Sponsors
A
Assistance Publique - Hôpitaux de Paris
Lead Sponsor
O
ORIXHA
Collaborating Sponsor
AI-Summary
What this Trial Is About
Less than 10% of patients eliciting out-of-hospital cardiac arrest (OHCA) survive, although 30% can be resuscitated by Emergency services before admission in Intensive Care Units (ICU). The majority succumb to Post-Cardiac Arrest Syndrome (PCAS). PCAS is associated with high mortality (60-70%) and morbidity. One proposed method of preventing the neurological and cardiac consequences of PCAS is to lower the body temperature to 33°C as quickly as possible. This approach is known as therapeutic hypothermia or Targeted Temperature Management (TTM). The Vent2Cool system, developed by Orixha, is a novel approach that enables the rapid induction of therapeutic hypothermia by using hypothermic Total Liquid Ventilation (TLV) to reach a protective temperature of 33°C within minutes. The OverCool feasibility study, which started in April 2025, is designed to validate the clinical performance and safety of an ultra-rapid cooling approach combining ultra-rapid hypothermia induction using the Vent2Cool system, and maintenance and rewarming using the ArcticSun system. The AfterCool study aims to evaluate long-term outcomes during a five-year follow-up of cardiac arrest survivors who were treated with ultrarapid cooling in the OverCool study.
CONDITIONS
Official Title
Long Term Follow-up of Cardiac Arrest Survivors Exposed to Ultra-rapid Cooling
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age of 18 years and over
- Cardiac arrest patient included in and alive at the end of the OverCool clinical investigation (28 days after the cardiac arrest)
- Non-opposition from the patient or the trusted person or the close relative or parent obtained within 3 months after the end of the OverCool study
You will not qualify if you...
- Follow-up refusal from patient or trusted person or close relative or parent
- Inclusion in OverCool clinical investigation without receiving the Vent2Cool procedure
- Inability to reach the patient or trusted person or close relative or parent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Angers University Hospital, Medical Intensive Care Unit, Vent'Lab
Angers, France, Alain MERCAT
Not Yet Recruiting
2
AP-HP Centre, Cochin Hospital, Medical Intensive Care Unit
Paris, France, 75014
Actively Recruiting
Research Team
A
Alain CARIOU, MD PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here