Comparison of Scores for Early Brain Damage Assessment at Intensive Care Unit Admission After Out of Hospital Cardiac Arrest

NCT04167891 | Completed

• 1 other identifier: AfterROSC1
• Study Type: observational
• Target: 1,144
• Locations: 2 countries
• Sites: 27

Brief 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. 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

Keywords

cardiac arrest; hypothermia induced; intensive care unit

Outcome Measures

Primary Outcomes (1)

• 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

  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

  Intensive Care Unit Admission (Usually 3 hours after cardiac arrest)

• Determination of Area Under Curve of simplified CAHP Score at intensive care unit admission

  Intensive Care Unit Admission (Usually 3 hours after cardiac arrest)

• Determination of Area Under Curve of OHCA Score at intensive care unit admission

  Intensive Care Unit Admission (Usually 3 hours after cardiac arrest)

• Determination of Area Under Curve of CREST Score at intensive care unit admission

  Intensive Care Unit Admission (Usually 3 hours after cardiac arrest)

• Determination of Area Under Curve of C-Graph Score at intensive care unit admission

  Intensive Care Unit Admission

Study Arms (1)

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

Diagnostic Test: Calculation of early prognosis score

Interventions

Calculation of early prognosis score DIAGNOSTIC_TEST

Early prognosis score will be calculated at intensive care unit admission for each patient based on clinical and biological values as required

Patients admitted in the intensive care unit

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• \- All adult patients, major, admitted to intensive care after out-of-hospital cardiac arrest and comatose (defined by Glasgow score ≤ 8) on admission.

You may not qualify if:

• cardiac arrest occurring intra-hospital,
• minor patient,
• major patient under guardianship,
• protected persons,

Sponsors & Collaborators

• AfterROSC: lead

Study Sites (27)

ERASME

Brussels, Belgium

Location

CHU Amiens

Amiens, France

Location

CHU Angers

Angers, France

Location

CH Bethune

Béthune, France

Location

CHU Ambroise Paré

Boulogne-Billancourt, France

Location

CH Brive La Gaillard

Brive-la-Gaillarde, France

Location

CH Cherbourg en Cotentin

Cherbourg, France

Location

CHU Créteil

Créteil, France

Location

CHD Vendée

La Roche-sur-Yon, France

Location

CH La Rochelle

La Rochelle, France

Location

CH Versailles

Le Chesnay, France

Location

CH Le Mans

Le Mans, France

Location

CHU Lille

Lille, France

Location

Hospices Civils Lyon

Lyon, France

Location

APHM

Marseille, France

Location

Hopital Privé Jacques Cartier

Massy, France

Location

CHU Montpellier

Montpellier, France

Location

CHRU Nancy

Nancy, France

Location

CHU Nantes

Nantes, France

Location

APHP, CHU Necker

Paris, France

Location

APHP, CHU Saint Louis

Paris, France

Location

Aphp, Hegp

Paris, France

Location

CHU Cochin

Paris, France

Location

CHU Lariboisière

Paris, France

Location

GHP Saint Joseph

Paris, France

Location

Clinique Privé Claude Galien

Quincy-sous-Sénart, France

Location

CH Toulon

Toulon, France

Location

Related Publications (2)

• 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.

  PMID: 40229890 DERIVED

• Lascarrou 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.

  PMID: 37819544 DERIVED

MeSH Terms

Conditions

Heart Arrest

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Alain Cariou, MD, PhD

  AfterROSC

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2019
• First Posted: November 19, 2019
• Study Start: August 1, 2020
• Primary Completion: June 30, 2022
• Study Completion: September 1, 2023
• Last Updated: September 26, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1); FR (26)