- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05606809
Comparison of Scores for Early Brain Damage Assessment at Intensive Care Unit Admission After Cardiac Arrest (AfterROSC2)
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Jean Baptiste Lascarrou, MD, PhD
- Phone Number: +33240087376
- Email: jeanbaptiste.lascarrou@chu-nantes.fr
Study Contact Backup
- Name: Alain Cariou, MD, PhD
- Email: alain.cariou@aphp.fr
Study Locations
-
-
-
Massy, France
- Recruiting
- Hopital Jacques Cartier
-
Contact:
- Wulfran Bougouin
- Email: wulfran.bougouin@gmail.com
-
Neuilly-sur-Seine, France
- Recruiting
- Clinique Ambroise Pare
-
Contact:
- Guillaume Geri
- Email: ggeri92@gmail.com
-
Paris, France
- Recruiting
- APHP, Cochin
-
Contact:
- Alain Cariou
- Email: alain.cariou@aphp.fr
-
Versailles, France
- Recruiting
- CH Versailles
-
Contact:
- Marine Paul
- Email: mpaul@ch-versailles.fr
-
-
Pays de Loire
-
Nantes, Pays de Loire, France
- Recruiting
- CHU Nantes
-
Contact:
- Jean Baptiste Lascarrou
- Email: jeanbaptiste.lascarrou@chu-nantes.fr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
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
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
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2022-A01811-42
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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