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

January 29, 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

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

4500

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

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 3 years, and investigators plan to include 4500 patients in 20 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 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

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

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

Collaborators and Investigators

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

Sponsor

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)

November 2, 2022

Primary Completion (Estimated)

December 2, 2025

Study Completion (Estimated)

December 2, 2025

Study Registration Dates

First Submitted

October 31, 2022

First Submitted That Met QC Criteria

November 4, 2022

First Posted (Actual)

November 7, 2022

Study Record Updates

Last Update Posted (Actual)

January 30, 2024

Last Update Submitted That Met QC Criteria

January 29, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-A01811-42

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Sharing of IPD will be possible upon request to steering committee of the AfterROSC Network after approval of the project by ethics committee.

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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Locations

3
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