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OpenTrials
Completed

NCT Number: NCT04167891

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

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.

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Key information

Conditions

Cardiac Arrest Cardiovascular Diseases Heart Arrest Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

ERASME, Brussels, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

Sponsors and collaborators

Lead sponsor

AfterROSC

Other

Registry information

Acronym: AfterROSC1

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
Nov 19, 2019
Registry last updated
Sep 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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