Cardiac ArrestAfterROSC1NCT04167891
Comparison of Scores for Early Brain Damage Assessment at Intensive Care Unit Admission After Out of Hospital Cardiac Arrest
An observational study of Cardiac Arrest, run by AfterROSC at 27 sites in 2 countries.
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
- 1,144 participants
- Where
- 27 sitesin 2 countries
- Study dates
- 1 Aug 2020to 1 Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 1 year, and we plan to include 597 patients in 21 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 out-of-hospital cardiac arrest and 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
27 sites in 2 countries.
27 sites in 2 countries
France26 sites
CHU Amiens
Amiens
CHU Angers
Angers
CH Bethune
Béthune
CHU Ambroise Paré
Boulogne-Billancourt
CH Brive La Gaillard
Brive-la-Gaillarde
CH Cherbourg en Cotentin
Cherbourg
CHU Créteil
Créteil
CHD Vendée
La Roche-sur-Yon
CH La Rochelle
La Rochelle
CH Versailles
Le Chesnay
CH Le Mans
Le Mans
CHU Lille
Lille
Hospices Civils Lyon
Lyon
APHM
Marseille
Hopital Privé Jacques Cartier
Massy
CHU Montpellier
Montpellier
CHRU Nancy
Nancy
CHU Nantes
Nantes
APHP, CHU Necker
Paris
APHP, CHU Saint Louis
Paris
Aphp, Hegp
Paris
CHU Cochin
Paris
CHU Lariboisière
Paris
GHP Saint Joseph
Paris
Clinique Privé Claude Galien
Quincy-sous-Sénart
CH Toulon
Toulon
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, hypothermia induced, intensive care unit
- 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
| Study group | Role | What they receive |
|---|---|---|
| Patients admitted in the intensive care unit | Patients with return of spontaneous circulation after cardiac arrest regardless of initial rhythm, and admitted in intensive care unit for post cardiac arrest care Receives: Diagnostic Test: Calculation of early prognosis score |
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)
Secondary outcomes (8)
Determination of Area Under Curve of modified CAHP Score at intensive care unit admission
Determination of AUC for modified CAHP score as compare to Utstein style criteria
mCAHP score range from 0 to 280 with higher score indicates poorer prognosis
Measured: Intensive Care Unit Admission (Usually 3 hours after cardiac arrest)
Determination of Area Under Curve of simplified CAHP Score at intensive care unit admission
Determination of AUC for simplified CAHP score as compare to Utstein style criteria
sCAHP score range from 0 to 150 with higher score indicates poorer prognosis
Measured: Intensive Care Unit Admission (Usually 3 hours after cardiac arrest)
Determination of Area Under Curve of OHCA Score at intensive care unit admission
Determination of AUC for OHCA score as compare to Utstein style criteria
OHCA score range from -30 to 60 with higher score indicates poorer prognosis
Measured: Intensive Care Unit Admission (Usually 3 hours after cardiac arrest)
Determination of Area Under Curve of CREST Score at intensive care unit admission
Determination of AUC for CREST score as compare to Utstein style criteria
CREST score range from 0 to 5 with higher score indicates poorer prognosis
Measured: Intensive Care Unit Admission (Usually 3 hours after cardiac arrest)
Determination of Area Under Curve of C-Graph Score at intensive care unit admission
Determination of AUC for C-Graph score as compare to Utstein style criteria
C-Graph score range from 0 to 5 with higher score indicates poorer prognosis
Measured: Intensive Care Unit Admission
Determination of Area Under Curve of TTM Score at intensive care unit admission
Determination of AUC for TTM score as compare to Utstein style criteria
TTM score range from -2 to 35 with higher score indicates poorer prognosis
Measured: Intensive Care Unit Admission (Usually 3 hours after cardiac arrest)
Determination of Area Under Curve of NULL-PLEASE Score at intensive care unit admission
Determination of AUC for NULL-PLEASE score as compare to Utstein style criteria
NULL-PLEASE score range from 0 to 14 with higher score indicates poorer prognosis
Measured: Intensive Care Unit Admission (Usually 3 hours after cardiac arrest)
Determination of calibration of each score
Determination of calibration of: CAHP, sCAHP, mCAHP, OHCA, CREST, C-Graph, TTM and NULL-PLEASE score
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 posted19 Nov 2019
- Study start1 Aug 2020
- Primary completion30 Jun 2022
- Study completion1 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- 1,144 participants (actual)
Sponsor and investigators
- Lead sponsor
- AfterROSC
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alain Cariou, MD, PhD, Study chair, AfterROSC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04167891
- Sponsor's protocol ID
- AfterROSC1
- Acronym
- AfterROSC1
- Status last verified
- Sep 2024
- First submitted
- 13 Nov 2019
- Last updated
- 26 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Renaudier M, Lascarrou JB, Chelly J, Lesieur O, Bourenne J, Jaubert P, Paul M, Muller G, Leprovost P, Klein T, Yansli M, Daubin C, Petit M, Pichon N, Cour M, Sboui G, Geri G, Cariou A, Bougouin W. Fluid balance and outcome in cardiac arrest patients admitted to intensive care unit. Crit Care. 2025 Apr 14;29(1):152. doi: 10.1186/s13054-025-05391-x.
PubMed 40229890Lascarrou JB, Bougouin W, Chelly J, Bourenne J, Daubin C, Lesieur O, Asfar P, Colin G, Paul M, Chudeau N, Muller G, Geri G, Jacquier S, Pichon N, Klein T, Sauneuf B, Klouche K, Cour M, Sejourne C, Annoni F, Raphalen JH, Galbois A, Bruel C, Mongardon N, Aissaoui N, Deye N, Maizel J, Dumas F, Legriel S, Cariou A; AfterROSC Network. Prospective comparison of prognostic scores for prediction of outcome after out-of-hospital cardiac arrest: results of the AfterROSC1 multicentric study. Ann Intensive Care. 2023 Oct 11;13(1):100. doi: 10.1186/s13613-023-01195-w.
PubMed 37819544
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2024. 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 Out of Hospital Cardiac Arrest
- ClinicalTrials.gov ID
- NCT04167891
- Acronym / sponsor ID
- AfterROSC1 / AfterROSC1
- Conditions
- Cardiac Arrest
- Keywords
- cardiac arrest, hypothermia induced, intensive care unit
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,144 participants (actual)
- Lead sponsor
- AfterROSCUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 19 Nov 2019 (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
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients admitted in the intensive care unit | – | Diagnostic Test: Calculation of early prognosis scorePatients with return of spontaneous circulation after cardiac arrest regardless of initial rhythm, and admitted in intensive care unit for post cardiac arrest care |
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 1 year, and we plan to include 597 patients in 21 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 (1 listed)
- All adult patients, major, admitted to intensive care after out-of-hospital cardiac arrest and 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 | Patients admitted in the intensive care unit |
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
8 secondary outcomes
Determination of Area Under Curve of modified CAHP Score at intensive care unit admission
Time frame: Intensive Care Unit Admission (Usually 3 hours after cardiac arrest)
Determination of Area Under Curve of simplified CAHP Score at intensive care unit admission
Time frame: Intensive Care Unit Admission (Usually 3 hours after cardiac arrest)
Determination of Area Under Curve of OHCA Score at intensive care unit admission
Time frame: Intensive Care Unit Admission (Usually 3 hours after cardiac arrest)
Determination of Area Under Curve of CREST Score at intensive care unit admission
Time frame: Intensive Care Unit Admission (Usually 3 hours after cardiac arrest)
Determination of Area Under Curve of C-Graph Score at intensive care unit admission
Time frame: Intensive Care Unit Admission
Determination of Area Under Curve of TTM Score at intensive care unit admission
Time frame: Intensive Care Unit Admission (Usually 3 hours after cardiac arrest)
Determination of Area Under Curve of NULL-PLEASE Score at intensive care unit admission
Time frame: Intensive Care Unit Admission (Usually 3 hours after cardiac arrest)
Determination of calibration of each score
Time frame: Intensive Care Unit Admission (Usually 3 hours after cardiac arrest)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2024.
- Derived from this study: PubMed 40229890Renaudier M, Lascarrou JB, Chelly J, Lesieur O, Bourenne J, Jaubert P, Paul M, Muller G, Leprovost P, Klein T, Yansli M, Daubin C, Petit M, Pichon N, Cour M, Sboui G, Geri G, Cariou A, Bougouin W. Fluid balance and outcome in cardiac arrest patients admitted to intensive care unit. Crit Care. 2025 Apr 14;29(1):152. doi: 10.1186/s13054-025-05391-x.
- Derived from this study: PubMed 37819544Lascarrou JB, Bougouin W, Chelly J, Bourenne J, Daubin C, Lesieur O, Asfar P, Colin G, Paul M, Chudeau N, Muller G, Geri G, Jacquier S, Pichon N, Klein T, Sauneuf B, Klouche K, Cour M, Sejourne C, Annoni F, Raphalen JH, Galbois A, Bruel C, Mongardon N, Aissaoui N, Deye N, Maizel J, Dumas F, Legriel S, Cariou A; AfterROSC Network. Prospective comparison of prognostic scores for prediction of outcome after out-of-hospital cardiac arrest: results of the AfterROSC1 multicentric study. Ann Intensive Care. 2023 Oct 11;13(1):100. doi: 10.1186/s13613-023-01195-w.
- Individual participant dataSharing planned: No
Related trials for Cardiac Arrest
RecruitingObservational study
AI-powered ECG Analysis Using Willem™ Software in High-risk Cardiac Patients (WILLEM)
Cardiomyopathies, Cardiac Arrest
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruitingObservational study
CAROTID DOPPLER AND CEREBRAL OXIMERY IN POST CARDIAC ARREST ICU PATIENTS
Cardiac Arrest (CA), Carotid Doppler
Active, not recruitingPhase 3
The Danish Out-of-Hospital Cardiac Arrest Study
Out-Of-Hospital Cardiac Arrest, Post-Cardiac Arrest Syndrome
RecruitingObservational study
Evaluation of Acid-base Disorders and Ventilation Settings in Cardiogenic Shock and Post-cardiac Arrest Patients: Comparison With VentilO Algorithm
Cardiac Arrest (CA), Cardiogenic Shock
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. This study is not recruiting at the moment.
Alain Cariou, MD, PhD study chair
AfterROSC
27 sites in 2 countries: 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 27 sites in 2 countries.
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 1 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: finished, as of the sponsor's last update on 26 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in France, Belgium. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. 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?
On the ClinicalTrials.gov record for NCT04167891, which also lists 2 linked publications.
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 26 Sep 2024.