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

September 24, 2024 updated by: AfterROSC
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

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1144

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Bruxelles, Belgium
        • Erasme
  • France
      • Amiens, France
        • CHU Amiens
      • Angers, France
        • CHU Angers
      • Boulogne-Billancourt, France
        • CHU Ambroise Paré
      • Brive-la-Gaillarde, France
        • CH Brive La Gaillard
      • Béthune, France
        • CH Béthune
      • Cherbourg, France
        • CH Cherbourg en Cotentin
      • Créteil, France
        • CHU CRETEIL
      • La Roche-sur-Yon, France
        • CHD Vendée
      • 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

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

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

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

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

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

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

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

This is where you will find people and organizations involved with this study.

Sponsor

AfterROSC

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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