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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03895736
Other study ID # 2019-A00239-48
Secondary ID 2019-A00239-48
Status Completed
Phase N/A
First received
Last updated
Start date February 24, 2020
Est. completion date February 10, 2022

Study information

Verified date September 2022
Source Assistance Publique - Hôpitaux de Paris
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine whether the blood transcriptome of patients resuscitated after out-of-hospital could be an early predictor of the neurological outcome.


Description:

Assessing the prognosis of the patients resuscitated after out-of-hospital cardiac arrest (OHCA) is still highly challenging. Beyond usual neurological markers, experimental and clinical studies have also shown that blood levels of several cytokines or miRNA could be significantly different after cardiac arrest in subjects prematurely died as compared to survivors with a good neurological recovery. Here the investigators propose to investigate a screening approach assessing simultaneously multiple targets of the post-cardiac arrest syndrome through analysis of the whole transcriptome of patients after OHCA. For this purpose, the investigators will collect blood samples from 60 patients after admission at hospital and then 1 and 3 days later. The Pittsburgh Cerebral Performance Category of each patient will be evaluated for each patient at day 60 after cardiac arrest. At the end of the collection period, the blood samples will be prepared for whole genome analysis and RNA sequencing. The primary analysis of the investigators will be the comparison of the transcriptome at day 0 after cardiac arrest in patients reaching Cerebral Performance Category (CPC) 1 at day 60 as compared to all other patients.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date February 10, 2022
Est. primary completion date February 10, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - Age between 18 and 80 years - Delay between patients collapse and resumption of spontaneous circulation (ROSC) < 60 minutes - Comatose patients ROSC with Glasgow score < 7 - Patient already registered in the social security system - Consent of a family member, if able to understand in the emergency context, or attestation of emergency situation with a follow-up information notice Exclusion Criteria: - Cardiac arrest supposed to be provoked by trauma or sepsis

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
blood sampling
Sampling of 15 ml of blood during a blood test at Day 0, Day 1 and Day 3

Locations

Country Name City State
France Hôpital Cochin, Assistance Publique Hôpitaux de Paris Paris

Sponsors (6)

Lead Sponsor Collaborator
Assistance Publique - Hôpitaux de Paris Ecole Nationale Vétérinaire d'Alfort, Institut National de la Santé Et de la Recherche Médicale, France, National Research Agency, France, Université Paris Est Créteil, University of Paris 5 - Rene Descartes

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Early Transcriptome at hospital admission Blood samples will be collected for each patient early after admission at hospital and blood whole transcriptome will be assessed by RNA sequencing Day 0
Primary Pittsburgh Cerebral Performance Category at Day 60 Pittsburgh Cerebral Performance Category will be evaluated for each patient at day 60 Day 60
Secondary Transcriptome at day 1 Blood samples will be collected for each patient at day 1 and blood whole transcriptome will be assessed by RNA sequencing Day 1
Secondary Transcriptome at day 3 Blood samples will be collected for each patient at day 3 and blood whole transcriptome will be assessed by RNA sequencing Day 3
Secondary Pittsburgh Cerebral Performance Category at Day 28 Pittsburgh Cerebral Performance Category will be evaluated for each patient at day 28 day 28
Secondary Number of participants with death at day 28 day 28
Secondary Number of participants with death at day 60 day 60