NCT03895736

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 21, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 29, 2019

Completed
11 months until next milestone

Study Start

First participant enrolled

February 24, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 10, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 10, 2022

Completed
Last Updated

November 20, 2025

Status Verified

October 1, 2025

Enrollment Period

2 years

First QC Date

March 21, 2019

Last Update Submit

November 17, 2025

Conditions

Keywords

Transcriptomemessenger ribonucleic acid (mRNA)sequencingbiomarkercardiac arrestprognosticationsuccessful resuscitation

Outcome Measures

Primary Outcomes (2)

  • 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

  • Pittsburgh Cerebral Performance Category at Day 60

    Pittsburgh Cerebral Performance Category will be evaluated for each patient at day 60

    Day 60

Secondary Outcomes (5)

  • Transcriptome at day 1

    Day 1

  • Transcriptome at day 3

    Day 3

  • Pittsburgh Cerebral Performance Category at Day 28

    day 28

  • Number of participants with death at day 28

    day 28

  • Number of participants with death at day 60

    day 60

Interventions

blood samplingBIOLOGICAL

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

Also known as: Blood sampling at Day 0, Day 1 and Day 3

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Cardiac arrest supposed to be provoked by trauma or sepsis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Cochin, Assistance Publique Hôpitaux de Paris

Paris, 75005, France

Location

MeSH Terms

Conditions

Heart Arrest

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Alain Cariou, Prof.

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR
  • Renaud Tissier, Prof

    Ecole Nationale Vétérinaire d'Alfort

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 21, 2019

First Posted

March 29, 2019

Study Start

February 24, 2020

Primary Completion

February 10, 2022

Study Completion

February 10, 2022

Last Updated

November 20, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations