NCT02292147

Brief Summary

Descriptive and prognosis study of the functional outcome after cardiac arrest for the patients awake within the first 15 days.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
140

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2013

Longer than P75 for all trials

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

Study Start

First participant enrolled

March 13, 2013

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

November 12, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 17, 2014

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 20, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 20, 2017

Completed
Last Updated

August 19, 2020

Status Verified

November 1, 2017

Enrollment Period

4.6 years

First QC Date

November 12, 2014

Last Update Submit

August 17, 2020

Conditions

Out of Hospital Cardiac Arrest

Keywords

Cerebral anoxiaFunctional outcome

Outcome Measures

Primary Outcomes (1)

  • Glasgow outcome Scale Extended score

    Functional outcome at 18 months

    18 months

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients presenting an Out of hospital cardiac arrest

You may qualify if:

  • age 18 to 85
  • Out of hospital cardiac arrest ; cardiac arrest in the ER is eligible
  • Glasgow Coma Score ≥ 12 within 15 days after onset
  • Living in the parisian area

You may not qualify if:

  • no social security
  • Neurological condition (multiple sclerosis, parkinson disease, AMS, stroke) priori to the cardiac arrest
  • Psychiatric condition (schizophrenia, severe bipolar syndrome, long term neuroleptic medication, autistic spectrum disorders
  • Deafness and blindness
  • Neoplasia
  • Premorbid limitation of autonomy.
  • Difficulties in speaking and writing the French language

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pitié salpetriere Hospital

Paris, 75013, France

Location

Related Publications (1)

  • Peskine A, Cariou A, Hajage D, Deye N, Guerot E, Dres M, Sonneville R, Lafourcade A, Navarro V, Robert H, Azouvi P, Sharshar T, Bayen E, Luyt CE; Hanox Study Group. Long-Term Disabilities of Survivors of Out-of-Hospital Cardiac Arrest: The Hanox Study. Chest. 2021 Feb;159(2):699-711. doi: 10.1016/j.chest.2020.07.022. Epub 2020 Jul 20.

    PMID: 32702410RESULT

MeSH Terms

Conditions

Out-of-Hospital Cardiac ArrestHypoxia, Brain

Condition Hierarchy (Ancestors)

Heart ArrestHeart DiseasesCardiovascular DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesHypoxiaSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Anne Peskine, MD

    Assistance Publique - Hôpitaux de Paris

    STUDY DIRECTOR

  • Charles-Edouard Luyt, MD, PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 12, 2014

First Posted

November 17, 2014

Study Start

March 13, 2013

Primary Completion

October 20, 2017

Study Completion

October 20, 2017

Last Updated

August 19, 2020

Record last verified: 2017-11

Locations

FR(1)