Cardiac ArrestAfterROSC2NCT05606809
Comparison of Scores for Early Brain Damage Assessment at Intensive Care Unit Admission After Cardiac Arrest
An observational study of Cardiac Arrest, run by AfterROSC at 5 sites in France.
Trial summary
Even in patients with successful return of spontaneous circulation (ROSC), outcome after cardiac arrest remains poor. The overall in-hospital survival rate widely varies both worldwide and across communities, from 1 to 4 folds according to circumstances of arrest and post-resuscitation interventions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Arrest
- What is being tested?
- Calculation of early prognosis score
- How many people
- 4,500 participants
- Where
- 5 sitesFrance
- Study dates
- 2 Nov 2022to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This is an observational, prospective, multicentric prognostic study. The study period is 3 years, and investigators plan to include 4500 patients in 20 ICUs in France. For all patients included, medical history, clinical data, paraclinical results and outcome (at hospital discharge and at 3 months, including modified Rankin score) will be prospectively collected by local investigator, according to an electronical CRF.
Who may be able to join
- all adult patients, major, admitted to intensive care after cardiac arrest (after both in and out-of hospital cardiac arrest),
- comatose (defined by Glasgow score ≤ 8) on admission,
Who cannot join
- cardiac arrest occurring intra-hospital,
- minor patient,
- major patient under guardianship,
- protected persons,
- prior inclusion in the study
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Alain Cariou, MD, PhD contact
5 sites in 1 country
France5 sites, 5 recruiting
- Recruiting
Hopital Jacques Cartier
Massy
Wulfran Bougouin, wulfran.bougouin@gmail.com
- Recruiting
CHU Nantes
Nantes, Pays de Loire
Jean Baptiste Lascarrou, jeanbaptiste.lascarrou@chu-nantes.fr
- Recruiting
Clinique Ambroise Paré
Neuilly-sur-Seine
Guillaume Geri, ggeri92@gmail.com
- Recruiting
APHP, Cochin
Paris
Alain Cariou, alain.cariou@aphp.fr
- Recruiting
CH Versailles
Versailles
Marine Paul, mpaul@ch-versailles.fr
About this study
Even in patients with successful return of spontaneous circulation (ROSC), outcome after cardiac arrest remains poor. The overall in-hospital survival rate widely varies both worldwide and across communities, from 1 to 4 folds according to circumstances of arrest and post-resuscitation interventions. Several studies have already shown that early interventions performed after ROSC, such as treatment of the cause, targeted temperature management, optimal hemodynamic management and extra-corporeal life support in selected patients, could improve the outcome in post-cardiac arrest patients. However, the decision process regarding the allocation of these resources, in parallel with the management of patients' proxies, remains a complex challenge for physicians facing these situations. Consequently, several prediction models and scores have been developed in order to stratify the risk of unfavorable outcome and to discriminate the best candidates for post-resuscitation interventions. Overall, several scores exist, but external validation are lacking and direct comparisons are needed to assess relative interest of scoring systems. Indeed, establishing the optimal scoring system is crucial, for optimal treatment allocation and appropriate information to relatives.
- Conditions
- Cardiac Arrest
- Being tested
- Calculation of early prognosis score
- Keywords
- cardiac arrest, intensive care unit, mechanical ventilation
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calculation of early prognosis scoreDiagnostic test
Early prognosis score will be calculated at intensive care unit admission for each patient based on clinical and biological values as required
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of Area Under Curve of Cerebral Admission Hospital Prognosis (CAHP) Score at intensive care unit admission
Determination of AUC for CAHP score as compare to Utstein style criteria.
CAHP score range from 0 to 300 with higher score indicates poorer prognosis
Measured: Intensive Care Unit Admission (Usually 3 hours after cardiac arrest
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2022
- Study start2 Nov 2022
- Primary completion30 Sep 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac ArrestStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AfterROSC
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05606809
- Sponsor's protocol ID
- 2022-A01811-42
- Acronym
- AfterROSC2
- Status last verified
- Nov 2026
- First submitted
- 31 Oct 2022
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Sharing of IPD will be possible upon request to steering committee of the AfterROSC Network after approval of the project by ethics committee.
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Scores for Early Brain Damage Assessment at Intensive Care Unit Admission After Cardiac Arrest
- ClinicalTrials.gov ID
- NCT05606809
- Acronym / sponsor ID
- AfterROSC2 / 2022-A01811-42
- Conditions
- Cardiac Arrest
- Keywords
- cardiac arrest, intensive care unit, mechanical ventilation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 4,500 participants (estimated)
- Lead sponsor
- AfterROSCUniversity, hospital or other
- Study start
- 2 Nov 2022 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 7 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Even in patients with successful return of spontaneous circulation (ROSC), outcome after cardiac arrest remains poor. The overall in-hospital survival rate widely varies both worldwide and across communities, from 1 to 4 folds according to circumstances of arrest and post-resuscitation interventions. Several studies have already shown that early interventions performed after ROSC, such as treatment of the cause, targeted temperature management, optimal hemodynamic management and extra-corporeal life support in selected patients, could improve the outcome in post-cardiac arrest patients. However, the decision process regarding the allocation of these resources, in parallel with the management of patients' proxies, remains a complex challenge for physicians facing these situations. Consequently, several prediction models and scores have been developed in order to stratify the risk of unfavorable outcome and to discriminate the best candidates for post-resuscitation interventions. Overall, several scores exist, but external validation are lacking and direct comparisons are needed to assess relative interest of scoring systems. Indeed, establishing the optimal scoring system is crucial, for optimal treatment allocation and appropriate information to relatives.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This is an observational, prospective, multicentric prognostic study. The study period is 3 years, and investigators plan to include 4500 patients in 20 ICUs in France. For all patients included, medical history, clinical data, paraclinical results and outcome (at hospital discharge and at 3 months, including modified Rankin score) will be prospectively collected by local investigator, according to an electronical CRF.
Key inclusion criteria (2 listed)
- all adult patients, major, admitted to intensive care after cardiac arrest (after both in and out-of hospital cardiac arrest),
- comatose (defined by Glasgow score ≤ 8) on admission,
Key exclusion criteria (5 listed)
- cardiac arrest occurring intra-hospital,
- minor patient,
- major patient under guardianship,
- protected persons,
- prior inclusion in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Calculation of early prognosis scoreEarly prognosis score will be calculated at intensive care unit admission for each patient based on clinical and biological values as required | Diagnostic test | – |
Primary outcome
Determination of Area Under Curve of Cerebral Admission Hospital Prognosis (CAHP) Score at intensive care unit admission
Time frame: Intensive Care Unit Admission (Usually 3 hours after cardiac arrest
Determination of AUC for CAHP score as compare to Utstein style criteria. CAHP score range from 0 to 300 with higher score indicates poorer prognosis
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Individual participant dataSharing planned: Undecided. Sharing of IPD will be possible upon request to steering committee of the AfterROSC Network after approval of the project by ethics committee.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alain Cariou, MD, PhD contact
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Arrest, run by AfterROSC at 5 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jean Baptiste Lascarrou, MD, PhD (+33240087376, jeanbaptiste.lascarrou@chu-nantes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determination of Area Under Curve of Cerebral Admission Hospital Prognosis (CAHP) Score at intensive care unit admission (time frame: Intensive Care Unit Admission (Usually 3 hours after cardiac arrest). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.