Out of Hospital Cardiac ArrestHANOXNCT02292147
Functional Outcome After Cardiac Arrest
An observational study of Out of Hospital Cardiac Arrest, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Descriptive and prognosis study of the functional outcome after cardiac arrest for the patients awake within the first 15 days. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Out of Hospital Cardiac Arrest
- How many people
- 140 participants
- Where
- 1 siteFrance
- Study dates
- 13 Mar 2013to 20 Oct 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients presenting an Out of hospital cardiac arrest
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Functional Outcome After Cardiac Arrest; Prediction and Prognosis Factors for Patients Awake Within the First 15 Days
Descriptive and prognosis study of the functional outcome after cardiac arrest for the patients awake within the first 15 days.
Read the 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.
- Conditions
- Out of Hospital Cardiac Arrest
- Keywords
- Cerebral anoxia, Functional outcome
- Medical subject headings
- Out-of-Hospital Cardiac Arrest, Hypoxia, Brain
What is being measured
The primary outcome is the main question the study is designed to answer.
Glasgow outcome Scale Extended score
Functional outcome at 18 months
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2014 (estimated)
- Study start13 Mar 2013
- Primary completion20 Oct 2017
- Study completion20 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Out of Hospital Cardiac ArrestStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anne Peskine, MD, Study director, Assistance Publique - Hôpitaux de ParisCharles-Edouard Luyt, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02292147
- Sponsor's protocol ID
- P111012
- Acronym
- HANOX
- Status last verified
- Nov 2017
- First submitted
- 12 Nov 2014
- Last updated
- 19 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 32702410
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Outcome After Cardiac Arrest; Prediction and Prognosis Factors for Patients Awake Within the First 15 Days
- ClinicalTrials.gov ID
- NCT02292147
- Acronym / sponsor ID
- HANOX / P111012
- Conditions
- Out of Hospital Cardiac Arrest
- Keywords
- Cerebral anoxia, Functional outcome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 13 Mar 2013 (actual)
- Primary completion
- 20 Oct 2017 (actual)
- Study completion
- 20 Oct 2017 (actual)
- First posted
- 17 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Descriptive and prognosis study of the functional outcome after cardiac arrest for the patients awake within the first 15 days.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients presenting an Out of hospital cardiac arrest
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Glasgow outcome Scale Extended score
Time frame: 18 months
Functional outcome at 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2020.
- Results publication: PubMed 32702410Peskine 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne Peskine, MD study director
Assistance Publique - Hôpitaux de Paris
Charles-Edouard Luyt, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Out of Hospital Cardiac Arrest, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glasgow outcome Scale Extended score (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02292147, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2020.