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

Cardiac Arrest Clinical Trial

— AfterROSC1  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04167891
• Other study ID #: AfterROSC1
• Status: Completed
• Start date: August 1, 2020
• Est. completion date: September 1, 2023

Study information

• Verified date: September 2023
• Source: AfterROSC
• Contact: n/a
• 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: Completed
• Enrollment: 907
• Est. completion date: September 1, 2023
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Cardiac Arrest
• Heart Arrest
• Out-of-Hospital Cardiac 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
Belgium	ERASME	Bruxelles
France	CHU Amiens	Amiens
France	CHU Angers	Angers
France	CH Bethune	Béthune
France	CHU Ambroise Paré	Boulogne-Billancourt
France	CH Brive La Gaillard	Brive-la-Gaillarde
France	CH Cherbourg en Cotentin	Cherbourg
France	CHU Créteil	Créteil
France	CHD Vendée	La Roche-sur-Yon
France	CH La Rochelle	La Rochelle
France	CH Versailles	Le Chesnay
France	CH Le Mans	Le Mans
France	CHU Lille	Lille
France	Hospices Civils Lyon	Lyon
France	APHM	Marseille
France	Hopital Privé Jacques Cartier	Massy
France	CHU Montpellier	Montpellier
France	CHRU Nancy	Nancy
France	CHU Nantes	Nantes
France	APHP, CHU Necker	Paris
France	APHP, CHU Saint Louis	Paris
France	Aphp, Hegp	Paris
France	CHU Cochin	Paris
France	CHU Lariboisière	Paris
France	GHP Saint Joseph	Paris
France	Clinique Privé Claude Galien	Quincy-sous-Sénart
France	CH Toulon	Toulon

Sponsors (1)

Lead Sponsor	Collaborator
AfterROSC

Countries where clinical trial is conducted

Belgium,  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)
Secondary	Determination of Area Under Curve of modified CAHP Score at intensive care unit admission	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	Intensive Care Unit Admission (Usually 3 hours after cardiac arrest)
Secondary	Determination of Area Under Curve of simplified CAHP Score at intensive care unit admission	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	Intensive Care Unit Admission (Usually 3 hours after cardiac arrest)
Secondary	Determination of Area Under Curve of OHCA Score at intensive care unit admission	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	Intensive Care Unit Admission (Usually 3 hours after cardiac arrest)
Secondary	Determination of Area Under Curve of CREST Score at intensive care unit admission	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	Intensive Care Unit Admission (Usually 3 hours after cardiac arrest)
Secondary	Determination of Area Under Curve of C-Graph Score at 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	Intensive Care Unit Admission
Secondary	Determination of Area Under Curve of TTM Score at intensive care unit admission	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	Intensive Care Unit Admission (Usually 3 hours after cardiac arrest)
Secondary	Determination of Area Under Curve of NULL-PLEASE Score at intensive care unit admission	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	Intensive Care Unit Admission (Usually 3 hours after cardiac arrest)
Secondary	Determination of calibration of each score	Determination of calibration of: CAHP, sCAHP, mCAHP, OHCA, CREST, C-Graph, TTM and NULL-PLEASE score	Intensive Care Unit Admission (Usually 3 hours after cardiac arrest)