- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04167891
Comparison of Scores for Early Brain Damage Assessment at Intensive Care Unit Admission After Out of Hospital Cardiac Arrest (AfterROSC1)
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Contact
- Name: Jean Baptiste Lascarrou, MD
- Phone Number: +33240087376
- Email: jeanbaptiste.lascarrou@chu-nantes.fr
Study Contact Backup
- Name: Alain Cariou, MD,PhD
- Email: alain.cariou@aphp.fr
Study Locations
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Bruxelles, Belgium
- Erasme
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Amiens, France
- CHU Amiens
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Angers, France
- CHU Angers
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Boulogne-Billancourt, France
- CHU Ambroise Paré
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Brive-la-Gaillarde, France
- CH Brive La Gaillard
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Béthune, France
- CH Bethune
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Cherbourg, France
- CH Cherbourg en Cotentin
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Créteil, France
- CHU Créteil
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La Roche-sur-Yon, France
- CHD Vendée
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La Rochelle, France
- CH La Rochelle
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Le Chesnay, France
- CH Versailles
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Le Mans, France
- CH Le Mans
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Lille, France
- CHU Lille
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Lyon, France
- Hospices Civils LYON
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Marseille, France
- APHM
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Massy, France
- Hôpital Privé Jacques Cartier
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Montpellier, France
- Chu Montpellier
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Nancy, France
- CHRU Nancy
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Nantes, France
- CHU Nantes
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Paris, France
- CHU Lariboisière
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Paris, France
- CHU Cochin
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Paris, France
- APHP, CHU Necker
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Paris, France
- APHP, CHU Saint Louis
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Paris, France
- Aphp, Hegp
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Paris, France
- GHP Saint Joseph
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Quincy-sous-Sénart, France
- Clinique Privé Claude Galien
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Toulon, France
- CH Toulon
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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 1 year, and we plan to include 597 patients in 21 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 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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Patients admitted in the intensive care unit
Patients with return of spontaneous circulation after cardiac arrest regardless of initial rhythm, and admitted in intensive care unit for post cardiac arrest care
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Early prognosis score will be calculated at intensive care unit admission for each patient based on clinical and biological values as required
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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)
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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)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Determination of Area Under Curve of modified CAHP Score at intensive care unit admission
Time Frame: Intensive Care Unit Admission (Usually 3 hours after cardiac arrest)
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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)
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Determination of Area Under Curve of simplified CAHP Score at intensive care unit admission
Time Frame: Intensive Care Unit Admission (Usually 3 hours after cardiac arrest)
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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)
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Determination of Area Under Curve of OHCA Score at intensive care unit admission
Time Frame: Intensive Care Unit Admission (Usually 3 hours after cardiac arrest)
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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)
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Determination of Area Under Curve of CREST Score at intensive care unit admission
Time Frame: Intensive Care Unit Admission (Usually 3 hours after cardiac arrest)
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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)
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Determination of Area Under Curve of C-Graph Score at intensive care unit admission
Time Frame: Intensive Care Unit Admission
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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
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Determination of Area Under Curve of TTM Score at intensive care unit admission
Time Frame: Intensive Care Unit Admission (Usually 3 hours after cardiac arrest)
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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)
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Determination of Area Under Curve of NULL-PLEASE Score at intensive care unit admission
Time Frame: Intensive Care Unit Admission (Usually 3 hours after cardiac arrest)
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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)
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Determination of calibration of each score
Time Frame: Intensive Care Unit Admission (Usually 3 hours after cardiac arrest)
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Determination of calibration of: CAHP, sCAHP, mCAHP, OHCA, CREST, C-Graph, TTM and NULL-PLEASE score
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Intensive Care Unit Admission (Usually 3 hours after cardiac arrest)
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Alain Cariou, MD, PhD, AfterROSC
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AfterROSC1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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