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Functional Outcome After Cardiac Arrest (HANOX)

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ClinicalTrials.gov Identifier: NCT02292147
Recruitment Status : Completed
First Posted : November 17, 2014
Last Update Posted : August 19, 2020
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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

Condition or disease
Out of Hospital Cardiac Arrest

Detailed Description:

Functional outcome after cerebral anoxia due to cardiac arrest is poorly documented.. Survival after out of hospital cardiac arrest has improved and long term follow up of the patients is not routinely effective. Patients showing sign of awakening very early are considered in a good outcome group. Nevertheless they can experience some restriction and difficulties when they try to return to their premorbid level of functioning.

We aim to study their long term functional outcome and their level of anxiety, depression, quality of life and caregiver burden as well as their general cognitive functioning. Prognosis factors will be studied in the acute phase.

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Study Type : Observational
Actual Enrollment : 140 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Functional Outcome After Cardiac Arrest; Prediction and Prognosis Factors for Patients Awake Within the First 15 Days
Actual Study Start Date : March 13, 2013
Actual Primary Completion Date : October 20, 2017
Actual Study Completion Date : October 20, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cardiac Arrest




Primary Outcome Measures :
  1. Glasgow outcome Scale Extended score [ Time Frame: 18 months ]
    Functional outcome at 18 months



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients presenting an Out of hospital cardiac arrest
Criteria

Inclusion criteria :

  • 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

Exclusion criteria :

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02292147


Locations
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France
Pitié salpetriere Hospital
Paris, France, 75013
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Study Director: Anne Peskine, MD Assistance Publique - Hôpitaux de Paris
Principal Investigator: Charles-Edouard Luyt, MD, PhD Assistance Publique - Hôpitaux de Paris
Publications of Results:
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02292147    
Other Study ID Numbers: P111012
First Posted: November 17, 2014    Key Record Dates
Last Update Posted: August 19, 2020
Last Verified: November 2017
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Cerebral anoxia
Functional outcome
Additional relevant MeSH terms:
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Heart Arrest
Out-of-Hospital Cardiac Arrest
Heart Diseases
Cardiovascular Diseases