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

Cardiac Arrest Clinical Trial

— AfterROSC2  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05606809
• Other study ID #: 2022-A01811-42
• Status: Recruiting
• Start date: November 2, 2022
• Est. completion date: December 2, 2025

Study information

• Verified date: January 2024
• Source: AfterROSC
• Contact: Jean Baptiste Lascarrou, MD, PhD
• Phone: +33240087376
• Email: jeanbaptiste.lascarrou[@]chu-nantes.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 4500
• Est. completion date: December 2, 2025
• Est. primary completion date: December 2, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Cardiac Arrest
• Heart Arrest

Intervention

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

Locations

Country	Name	City	State
France	Hopital Jacques Cartier	Massy
France	CHU Nantes	Nantes	Pays De Loire
France	Clinique Ambroise Paré	Neuilly-sur-Seine
France	APHP, Cochin	Paris
France	CH Versailles	Versailles

Sponsors (1)

Lead Sponsor	Collaborator
AfterROSC

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Intensive Care Unit Admission (Usually 3 hours after cardiac arrest