Long Term Follow-up of Cardiac Arrest Survivors Exposed to Ultra-rapid Cooling
NCT ID: NCT07028372
Last Updated: 2025-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
12 participants
OBSERVATIONAL
2025-06-30
2031-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Lung-cOnservative Liquid VEntilation for the Induction of Ultra-Rapid COOLing After Cardiac Arrest
NCT06798818
Heart Rate Variability in Early Prediction of a Noxic Brain Injury After Cardiac Arrest
NCT06044922
Predictors for Survival and Good Neurological Outcome in E-CPR and Non CPR Treated Patients
NCT04198792
Evaluation of the Heart's Respiratory Quotient as Predictive Value After Extra-hospital Cardiac Arrest
NCT04211207
The Systematic Approach for Identification of Cause Among Out-of-hospital Cardiac Arrest Survivors
NCT06012838
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
One proposed method of preventing the neurological and cardiac complications 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). However, the cooling power of available technologies is insufficient to induce therapeutic hypothermia, and they do not improve outcomes for most patients. Conversely, experimental reports clearly demonstrate that therapeutic hypothermia can dramatically improve clinical outcomes if applied within two to three hours of resuscitation.
The devices currently available for TTM are mostly external cooling devices, such as blankets, pads and suits. These devices have a cooling performance of less than 1°C per hour in the body's core and in vital organs with high blood flow. Orixha's Vent2Cool is a novel approach that enables the induction of ultra-rapid therapeutic hypothermia (URTH) by using hypothermic total liquid ventilation (TLV) to reach a protective temperature of 33°C within minutes.
The OverCool feasibility study, which has been approved by the French authorities and began enrolment in early 2025, is designed to test the feasibility of ultra-rapid cooling. It aims 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. OverCool will pave the way for other clinical investigations to demonstrate the superior clinical benefits of this new approach to hypothermic TTM compared to the standard of care.
The AfterCool study will follow cardiac arrest survivors who were treated with ultrarapid cooling in the Overcool study for five years. The AfterCool approach aligns with the need to evaluate long-term outcomes after cardiac arrest, as endorsed by the French AfterROSC network, which supports research into post-cardiac arrest patients.
Eligible subjects, after having received clear, impartial and complete information, and not having objected to participation in the study, will be included. At the inclusion visit, a detailed questionnaire regarding life status, quality of life, putative rehospitalization, cardiovascular, neurological and respiratory status will be administered.
At 6±1 months and 12±1 months after inclusion, and then yearly during a total period of 5 years, the patients or trusted persons or the close relatives or parents will be interviewed by phone, using the same questionnaire regarding life status, quality of life, putative rehospitalization, cardiovascular, neurological and respiratory status.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Resuscitated OverCool clinical investigation participants alive at 28 days after cardiac arrest
Patients who were resuscitated after cardiac arrest, treated with ultrarapid cooling as part of the OverCool clinical investigation and survived until the end of the investigation (28 days after cardiac arrest and subsequent Vent2Cool treatment).
Short Form Health Survey (SF-36)
Heath-related quality-of-life is assessed using the SF-36 questionnaire, which is administered at the inclusion visite, then at month 6, year 1, year 2, year 3, year 4 and year 5, in the form of a telephone interview.
Modified Rankin Score (mRS)
The degree of disability/dependence is evaluated using the mRS scale at the inclusion visite, then at month 6, year 1, year 2, year 3, year 4 and year 5, via telephone interview.
Activity of Daily Living (ADL) questionnaire
Level of independence is evaluated using the ADL questionnaire, which is administered at the inclusion visite, then at month 6, year 1, year 2, year 3, year 4 and year 5, in the form of a telephone interview.
New York Heart Association (NYHA) Classification
The extent of heart failure is assessed using the NYHA functional classification at the inclusion visite, then at month 6, year 1, year 2, year 3, year 4 and year 5, via telephone interview.
St George's Respiratory Questionnaire (SGRQ)
Respiratory status is assessed using the SGRQ questionnaire at the inclusion visite, then at month 6, year 1, year 2, year 3, year 4 and year 5, via telephone interview.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Short Form Health Survey (SF-36)
Heath-related quality-of-life is assessed using the SF-36 questionnaire, which is administered at the inclusion visite, then at month 6, year 1, year 2, year 3, year 4 and year 5, in the form of a telephone interview.
Modified Rankin Score (mRS)
The degree of disability/dependence is evaluated using the mRS scale at the inclusion visite, then at month 6, year 1, year 2, year 3, year 4 and year 5, via telephone interview.
Activity of Daily Living (ADL) questionnaire
Level of independence is evaluated using the ADL questionnaire, which is administered at the inclusion visite, then at month 6, year 1, year 2, year 3, year 4 and year 5, in the form of a telephone interview.
New York Heart Association (NYHA) Classification
The extent of heart failure is assessed using the NYHA functional classification at the inclusion visite, then at month 6, year 1, year 2, year 3, year 4 and year 5, via telephone interview.
St George's Respiratory Questionnaire (SGRQ)
Respiratory status is assessed using the SGRQ questionnaire at the inclusion visite, then at month 6, year 1, year 2, year 3, year 4 and year 5, via telephone interview.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
* Having being included in the OverCool clinical investigation but not submitted to the Vent2Cool procedure
* Impossibility to reach the patient or the trusted person or the close relative or parent
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
ORIXHA
INDUSTRY
Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Alain CARIOU, MD PhD
Role: PRINCIPAL_INVESTIGATOR
AP-HP, Cochin Hospital, Intensive Care and Resuscitation Department
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Angers University Hospital, Medical Intensive Care Unit, Vent'Lab
Angers, , France
AP-HP Centre, Cochin Hospital, Medical Intensive Care Unit
Paris, , France
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Tissier R, Taccone FS, Lamhaut L, Vicaut E, Paublant F, Ricard JD, Mercat A, Cariou A. Design of the OverCool study: Lung-conservative liquid ventilation for the induction of Ultra-Rapid Cooling after Cardiac Arrest (OverCool). Resusc Plus. 2025 Mar 10;23:100926. doi: 10.1016/j.resplu.2025.100926. eCollection 2025 May.
Dumas F, Paoli A, Paul M, Savary G, Jaubert P, Chocron R, Varenne O, Mira JP, Charpentier J, Bougouin W, Cariou A. Association between previous health condition and outcome after cardiac arrest. Resuscitation. 2021 Oct;167:267-273. doi: 10.1016/j.resuscitation.2021.06.017. Epub 2021 Jul 7.
Bougouin W, Lascarrou JB, Chelly J, Benghanem S, Geri G, Maizel J, Fage N, Sboui G, Pichon N, Daubin C, Sauneuf B, Mongardon N, Taccone F, Hermann B, Colin G, Lesieur O, Deye N, Chudeau N, Cour M, Bourenne J, Klouche K, Klein T, Raphalen JH, Muller G, Galbois A, Bruel C, Jacquier S, Paul M, Sandroni C, Cariou A. Performance of the ERC/ESICM-recommendations for neuroprognostication after cardiac arrest: Insights from a prospective multicenter cohort. Resuscitation. 2024 Sep;202:110362. doi: 10.1016/j.resuscitation.2024.110362. Epub 2024 Aug 14.
Flajoliet N, Bourenne J, Marin N, Chelly J, Lascarrou JB, Daubin C, Bougouin W, Cariou A, Geri G. Return to work after out of hospital cardiac arrest, insights from a prospective multicentric French cohort. Resuscitation. 2024 Jun;199:110225. doi: 10.1016/j.resuscitation.2024.110225. Epub 2024 Apr 27.
Lascarrou JB, Merdji H, Le Gouge A, Colin G, Grillet G, Girardie P, Coupez E, Dequin PF, Cariou A, Boulain T, Brule N, Frat JP, Asfar P, Pichon N, Landais M, Plantefeve G, Quenot JP, Chakarian JC, Sirodot M, Legriel S, Letheulle J, Thevenin D, Desachy A, Delahaye A, Botoc V, Vimeux S, Martino F, Giraudeau B, Reignier J; CRICS-TRIGGERSEP Group. Targeted Temperature Management for Cardiac Arrest with Nonshockable Rhythm. N Engl J Med. 2019 Dec 12;381(24):2327-2337. doi: 10.1056/NEJMoa1906661. Epub 2019 Oct 2.
Arrich J, Herkner H, Mullner D, Behringer W. Targeted temperature management after cardiac arrest. A systematic review and meta-analysis of animal studies. Resuscitation. 2021 May;162:47-55. doi: 10.1016/j.resuscitation.2021.02.002. Epub 2021 Feb 12.
Kohlhauer M, Lidouren F, Remy-Jouet I, Mongardon N, Adam C, Bruneval P, Hocini H, Levy Y, Blengio F, Carli P, Vivien B, Ricard JD, Micheau P, Walti H, Nadeau M, Robert R, Richard V, Mulder P, Maresca D, Demene C, Pernot M, Tanter M, Ghaleh B, Berdeaux A, Tissier R. Hypothermic Total Liquid Ventilation Is Highly Protective Through Cerebral Hemodynamic Preservation and Sepsis-Like Mitigation After Asphyxial Cardiac Arrest. Crit Care Med. 2015 Oct;43(10):e420-30. doi: 10.1097/CCM.0000000000001160.
Darbera L, Chenoune M, Lidouren F, Kohlhauer M, Adam C, Bruneval P, Ghaleh B, Dubois-Rande JL, Carli P, Vivien B, Ricard JD, Berdeaux A, Tissier R. Hypothermic liquid ventilation prevents early hemodynamic dysfunction and cardiovascular mortality after coronary artery occlusion complicated by cardiac arrest in rabbits. Crit Care Med. 2013 Dec;41(12):e457-65. doi: 10.1097/CCM.0b013e3182a63b5d.
Che D, Li L, Kopil CM, Liu Z, Guo W, Neumar RW. Impact of therapeutic hypothermia onset and duration on survival, neurologic function, and neurodegeneration after cardiac arrest. Crit Care Med. 2011 Jun;39(6):1423-30. doi: 10.1097/CCM.0b013e318212020a.
Dankiewicz J, Cronberg T, Lilja G, Jakobsen JC, Levin H, Ullen S, Rylander C, Wise MP, Oddo M, Cariou A, Belohlavek J, Hovdenes J, Saxena M, Kirkegaard H, Young PJ, Pelosi P, Storm C, Taccone FS, Joannidis M, Callaway C, Eastwood GM, Morgan MPG, Nordberg P, Erlinge D, Nichol AD, Chew MS, Hollenberg J, Thomas M, Bewley J, Sweet K, Grejs AM, Christensen S, Haenggi M, Levis A, Lundin A, During J, Schmidbauer S, Keeble TR, Karamasis GV, Schrag C, Faessler E, Smid O, Otahal M, Maggiorini M, Wendel Garcia PD, Jaubert P, Cole JM, Solar M, Borgquist O, Leithner C, Abed-Maillard S, Navarra L, Annborn M, Unden J, Brunetti I, Awad A, McGuigan P, Bjorkholt Olsen R, Cassina T, Vignon P, Langeland H, Lange T, Friberg H, Nielsen N; TTM2 Trial Investigators. Hypothermia versus Normothermia after Out-of-Hospital Cardiac Arrest. N Engl J Med. 2021 Jun 17;384(24):2283-2294. doi: 10.1056/NEJMoa2100591.
Sandroni C, Nolan JP, Andersen LW, Bottiger BW, Cariou A, Cronberg T, Friberg H, Genbrugge C, Lilja G, Morley PT, Nikolaou N, Olasveengen TM, Skrifvars MB, Taccone FS, Soar J. ERC-ESICM guidelines on temperature control after cardiac arrest in adults. Intensive Care Med. 2022 Mar;48(3):261-269. doi: 10.1007/s00134-022-06620-5. Epub 2022 Jan 28.
Boissady E, Kohlhauer M, Lidouren F, Hocini H, Lefebvre C, Chateau-Jouber S, Mongardon N, Deye N, Cariou A, Micheau P, Ghaleh B, Tissier R. Ultrafast Hypothermia Selectively Mitigates the Early Humoral Response After Cardiac Arrest. J Am Heart Assoc. 2020 Dec;9(23):e017413. doi: 10.1161/JAHA.120.017413. Epub 2020 Nov 17.
Kohlhauer M, Boissady E, Lidouren F, de Rochefort L, Nadeau M, Rambaud J, Hutin A, Dubuisson RM, Guillot G, Pey P, Bruneval P, Fortin-Pellerin E, Sage M, Walti H, Cariou A, Ricard JD, Berdeaux A, Mongardon N, Ghaleh B, Micheau P, Tissier R. A new paradigm for lung-conservative total liquid ventilation. EBioMedicine. 2020 Feb;52:102365. doi: 10.1016/j.ebiom.2019.08.026. Epub 2019 Aug 22.
Chenoune M, Lidouren F, Adam C, Pons S, Darbera L, Bruneval P, Ghaleh B, Zini R, Dubois-Rande JL, Carli P, Vivien B, Ricard JD, Berdeaux A, Tissier R. Ultrafast and whole-body cooling with total liquid ventilation induces favorable neurological and cardiac outcomes after cardiac arrest in rabbits. Circulation. 2011 Aug 23;124(8):901-11, 1-7. doi: 10.1161/CIRCULATIONAHA.111.039388. Epub 2011 Aug 1.
Berdowski J, Berg RA, Tijssen JG, Koster RW. Global incidences of out-of-hospital cardiac arrest and survival rates: Systematic review of 67 prospective studies. Resuscitation. 2010 Nov;81(11):1479-87. doi: 10.1016/j.resuscitation.2010.08.006. Epub 2010 Sep 9.
Lemiale V, Dumas F, Mongardon N, Giovanetti O, Charpentier J, Chiche JD, Carli P, Mira JP, Nolan J, Cariou A. Intensive care unit mortality after cardiac arrest: the relative contribution of shock and brain injury in a large cohort. Intensive Care Med. 2013 Nov;39(11):1972-80. doi: 10.1007/s00134-013-3043-4. Epub 2013 Aug 14.
Dumas F, Bougouin W, Perier MC, Marin N, Goulenok C, Vieillard-Baron A, Diehl JL, Legriel S, Deye N, Cronier P, Ricome S, Chemouni F, Mekontso Dessap A, Beganton F, Marijon E, Jouven X, Empana JP, Cariou A. Long-term follow-up of cardiac arrest survivors: Protocol of the DESAC (Devenir des survivants d'Arrets Cardiaques) study, a French multicentric prospective cohort. Resusc Plus. 2023 Aug 31;16:100460. doi: 10.1016/j.resplu.2023.100460. eCollection 2023 Dec.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2025-A00442-47
Identifier Type: OTHER
Identifier Source: secondary_id
APHP250360
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.