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

Sponsor
AfterROSC (Other)
Overall Status
Recruiting
CT.gov ID
NCT04167891
Collaborator
(none)
597
4
28
149.3
5.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Calculation of early prognosis score

Study Design

Study Type:
Observational
Anticipated Enrollment :
597 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Comparison of Scores for Early Brain Damage Assessment at Intensive Care Unit Admission After Out of Hospital Cardiac Arrest
Actual Study Start Date :
Aug 1, 2020
Anticipated Primary Completion Date :
Sep 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Determination of Area Under Curve of Cerebral Admission Hospital Prognosis (CAHP) Score at intensive care unit admission [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 Outcome Measures

  1. 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 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 [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 [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 [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 [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 [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 [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 [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 CH Versailles Le Chesnay France
2 Hopital Privé Jacques Cartier Massy France
3 CHU Nantes Nantes France
4 CHU Cochin Paris France

Sponsors and Collaborators

  • AfterROSC

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
AfterROSC
ClinicalTrials.gov Identifier:
NCT04167891
Other Study ID Numbers:
  • AfterROSC1
First Posted:
Nov 19, 2019
Last Update Posted:
Aug 2, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by AfterROSC
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 2, 2022