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CompletedNCT04167891AfterROSC1Updated Sep 26, 2024

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

An observational study in Cardiac Arrest, sponsored by AfterROSC. Completed at 27 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-09-26.

Sponsored by AfterROSC · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,144
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Cardiac Arrest

Keywords

  • cardiac arrest
  • hypothermia induced
  • intensive care unit
03

In context

Brain Injuries

2,113 studies on the registry are indexed under Brain Injuries; 385 are open to participants now.

This study's enrollment of 1,144 is above the median of 100 across 690 observational studies indexed under Brain Injuries.

Browse Brain Injuries studies →

Lead sponsor

AfterROSC is the lead sponsor of 2 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

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

Exclusion Criteria:

  • cardiac arrest occurring intra-hospital,
  • minor patient,
  • major patient under guardianship,
  • protected persons,
  • prior inclusion in the study
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,144 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • Diagnostic testCalculation 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

06

What researchers measure

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

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

Secondary outcomes

  1. 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

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

  2. 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

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

  3. 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

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

  4. 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

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

  5. 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

    Time frame: Intensive Care Unit Admission

  6. 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

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

  7. 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

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

  8. Determination of calibration of each score

    Determination of calibration of: CAHP, sCAHP, mCAHP, OHCA, CREST, C-Graph, TTM and NULL-PLEASE score

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

07

Study locations

27 sites
  • ERASME
    Bruxelles, Belgium
  • CHU Amiens
    Amiens, France
  • CHU Angers
    Angers, France
  • CHU Ambroise Paré
    Boulogne-Billancourt, France
  • CH Brive La Gaillard
    Brive-la-Gaillarde, France
  • CH Bethune
    Béthune, France
  • CH Cherbourg en Cotentin
    Cherbourg, France
  • CHU Créteil
    Créteil, France
  • CHD Vendée
    La Roche-sur-Yon, France
  • CH La Rochelle
    La Rochelle, France
  • CH Versailles
    Le Chesnay, France
  • CH Le Mans
    Le Mans, France
  • CHU Lille
    Lille, France
  • Hospices Civils Lyon
    Lyon, France
  • APHM
    Marseille, France
  • Hopital Privé Jacques Cartier
    Massy, France
  • CHU Montpellier
    Montpellier, France
  • CHRU Nancy
    Nancy, France
  • CHU Nantes
    Nantes, France
  • APHP, CHU Necker
    Paris, France
  • APHP, CHU Saint Louis
    Paris, France
  • Aphp, Hegp
    Paris, France
  • CHU Cochin
    Paris, France
  • CHU Lariboisière
    Paris, France
  • GHP Saint Joseph
    Paris, France
  • Clinique Privé Claude Galien
    Quincy-sous-Sénart, France
  • CH Toulon
    Toulon, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 26, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04167891
Lead sponsor
AfterROSC
Responsible party
Sponsor
First posted
Nov 19, 2019
Start date
Aug 1, 2020
Primary completion
Jun 30, 2022
Completion
Sep 1, 2023
Last update
Sep 26, 2024

Study contacts

Alain Cariou, MD, PhD
study chair · AfterROSC

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.

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