AfterROSC2: Comparison of Scores for Early Brain Damage Assessment at Intensive Care Unit Admission After Cardiac Arrest

Sponsor
AfterROSC (Other)
Overall Status
Recruiting
CT.gov ID
NCT05606809
Collaborator
(none)
4,500
5
37
900
24.3

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 :
4500 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Comparison of Scores for Early Brain Damage Assessment at Intensive Care Unit Admission After Cardiac Arrest
Actual Study Start Date :
Nov 2, 2022
Anticipated Primary Completion Date :
Dec 2, 2025
Anticipated Study Completion Date :
Dec 2, 2025

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

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 cardiac arrest (after both in and out-of hospital cardiac arrest),

  • 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 CHU Nantes Nantes Pays De Loire France
2 Hopital Jacques Cartier Massy France
3 Clinique Ambroise Paré Neuilly-sur-Seine France
4 APHP, Cochin Paris France
5 CH Versailles Versailles France

Sponsors and Collaborators

  • AfterROSC

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
AfterROSC
ClinicalTrials.gov Identifier:
NCT05606809
Other Study ID Numbers:
  • 2022-A01811-42
First Posted:
Nov 7, 2022
Last Update Posted:
Dec 7, 2022
Last Verified:
Dec 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
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 Dec 7, 2022