Comparison of Scores for Early Brain Damage Assessment at Intensive Care Unit Admission After Out of Hospital Cardiac Arrest (AfterROSC1)

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 Overview

• Status: Completed
• Conditions: Cardiac Arrest
• Intervention / Treatment: Diagnostic test: Calculation of early prognosis score

• Study Type: Observational
• Enrollment (Actual): 1144

Contacts and Locations

Study Locations

• Belgium
  • Bruxelles, Belgium
    • Erasme
• France
  • Amiens, France
    • CHU Amiens
  • Angers, France
    • CHU Angers
  • Boulogne-Billancourt, France
    • CHU Ambroise Pare
  • Brive-la-Gaillarde, France
    • CH Brive La Gaillard
  • Béthune, France
    • CH Bethune
  • Cherbourg, France
    • CH Cherbourg en Cotentin
  • Créteil, France
    • CHU CRETEIL
  • La Roche-sur-Yon, France
    • CHD Vendee
  • La Rochelle, France
    • CH La Rochelle
  • Le Chesnay, France
    • CH Versailles
  • Le Mans, France
    • CH Le mans
  • Lille, France
    • Chu Lille
  • Lyon, France
    • Hospices civils Lyon
  • Marseille, France
    • APHM
  • Massy, France
    • Hôpital Privé Jacques Cartier
  • Montpellier, France
    • CHU Montpellier
  • Nancy, France
    • Chru Nancy
  • Nantes, France
    • CHU Nantes
  • Paris, France
    • Chu Lariboisiere
  • Paris, France
    • CHU Cochin
  • Paris, France
    • APHP, CHU Necker
  • Paris, France
    • APHP, CHU Saint Louis
  • Paris, France
    • Aphp, Hegp
  • Paris, France
    • GHP Saint Joseph
  • Quincy-sous-Sénart, France
    • Clinique Privé Claude Galien
  • Toulon, France
    • CH Toulon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• cardiac arrest occurring intra-hospital,
• minor patient,
• major patient under guardianship,
• protected persons,
• prior inclusion in the study

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Early prognosis score will be calculated at intensive care unit admission for each patient based on clinical and biological values as required

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	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	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	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	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	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	Intensive Care Unit Admission (Usually 3 hours after cardiac arrest)

Collaborators and Investigators

• Sponsor: AfterROSC
• Investigators: Study Chair: Alain Cariou, MD, PhD, AfterROSC

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2020
• Primary Completion (Actual): June 30, 2022
• Study Completion (Actual): September 1, 2023

Study Registration Dates

• First Submitted: November 13, 2019
• First Submitted That Met QC Criteria: November 15, 2019
• First Posted (Actual): November 19, 2019

Study Record Updates

• Last Update Posted (Actual): September 26, 2024
• Last Update Submitted That Met QC Criteria: September 24, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: intensive care unit; cardiac arrest; hypothermia induced
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Heart Arrest; Out-of-Hospital Cardiac Arrest
• Other Study ID Numbers: AfterROSC1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No