Cardiac ArrestHYPERION-2NCT06387225
Early and Objective Assessment of Neurological Prognosis in Cardiac Arrest Patients
An observational study of Cardiac Arrest and Neurologic Symptoms, run by Nantes University Hospital at 4 sites in France.
Trial summary
Cerebral lesions are responsible for two thirds of deaths in patients admitted to intensive care following cardiac arrest. Patients with neurological lesions should be the priority target for neuroprotective interventions, which are the cornerstone of post-cardiac arrest care (allowing a reduction in the burden of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Arrest, Neurologic Symptoms, Intensive Care Neurological Disorder
- How many people
- 608 participants
- Where
- 4 sitesFrance
- Study dates
- 2 Feb 2025to 31 May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients will be included on admission to intensive care.
Who may be able to join
- Age ≥ 18 years
- Admitted to intensive care with out-of-hospital cardiac arrest
- Comatose on admission (defined by a Glasgow score ≤ 8)
- Informed relative who has consented to the patient's participation in the study or inclusion under emergency procedure if the relative is absent at the time of inclusion
Who cannot join
- In-hospital cardiac arrest
- Age < 18 years
- Person under guardianship or legal protection
- Prior inclusion in the study
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France4 sites, 4 recruiting
- Recruiting
CHD Vendée
La Roche-sur-Yon, 85025
Gwenael COLIN
- Recruiting
CHU Nantes
Nantes, 44093
Jean-Baptiste LASCARROU
- Recruiting
APHP - Hôpital Cochin
Paris, 75679
Sarah BENGHANEM
- Recruiting
CH Saint-Nazaire
Saint-Nazaire, 44600
Julien LORBER
About this study
Cerebral lesions are responsible for two thirds of deaths in patients admitted to intensive care following cardiac arrest. Patients with neurological lesions should be the priority target for neuroprotective interventions, which are the cornerstone of post-cardiac arrest care (allowing a reduction in the burden of care for patients without this type of lesion). Furthermore, these interventions must be based on a precise assessment of the severity of these brain lesions: carrying out neuro-protective interventions in patients without brain lesions exposes these patients to unnecessary treatment potentially associated with adverse effects without any possible benefit. However, the early assessment of neurological prognosis, particularly on admission to intensive care, is an area where there is little research and where it is not possible to obtain a precise and reproducible assessment. Several tools can be used to assess this prognosis at an early stage: anamnesis and characteristics of the cardiac arrest and the patient's comorbidities, imaging, electrophysiology and biomarkers.
To assess the predictive value of early biomarker testing in patients resuscitated after cardiac arrest, whatever the cause, the investigators plan to conduct a prospective observational multicentre trial.
It is important to bear in mind that the aim of this study is not to assess the long-term prognosis of patients suffering cardiac arrest in order to take measures to limit or discontinue active therapies, but simply to provide a reliable tool, simple and quick to use, in order to be able to identify a sub-population of patients who should be the subject of preferential neuro-protection measures, and conversely to simplify management (moderate temperature control, early cessation of sedation, early extubation) for patients with no neurological lesions.
- Medical subject headings
- Heart Arrest, Neurologic Manifestations
What is being measured
The primary outcome is the main question the study is designed to answer.
Dosage of biomarker UCHL-1 (Ubiquitin carboxy-terminal hydrolase L1) at the time of admission to intensive care
Determine an assay threshold value admission to the intensive care unit to predict membership of a homogeneous group with favorable neurological outcome at D90
Measured: at ICU admission
Dosage of biomarker GFAP (Glial fibrillary acidic protein) at the time of admission to intensive care
Determine an assay threshold value admission to the intensive care unit to predict membership of a homogeneous group with favorable neurological outcome at D90
Measured: at ICU admission
Neurological outcome at D90 assessed by modified Rankin scale (mRS)
Determine an assay threshold value admission to the intensive care unit to predict membership of a homogeneous group with favorable neurological outcome at D90
Measured: 90 days after patient enrolment in the study
Secondary outcomes (5)
Dosage of biomarkers UCHL-1 ((Ubiquitin carboxy-terminal hydrolase L1) at the time of admission to intensive care
Determine prognostic value (positive and negative predictive value (PPV/NPV), positive and negative likelihood ratio (LR+/LR-) of each biomarker separately according to the threshold on admission.
Determine the value of combining the two biomarkers at admission.
Measured: at ICU admission
Dosage of biomarkers GFAP (Glial fibrillary acidic protein) at the time of admission to intensive care
Determine prognostic value (positive and negative predictive value (PPV/NPV), positive and negative likelihood ratio (LR+/LR-) of each biomarker separately according to the threshold on admission.
Determine the value of combining the two biomarkers at admission.
Measured: at ICU admission
Dosage of biomarkers UCHL-1 (Ubiquitin carboxy-terminal hydrolase L1) at 4 hours for recovery of effective cardiac activity (RACS)
Determine a threshold value at H4 for recovery of effective cardiac activity (RACS) to predict membership of a homogeneous group with a favorable neurological outcome at D90.
Determine interest of combining the two biomarkers at H4 of the RACS.
Measured: at 4 hours for recovery of effective cardiac activity (RACS)
Dosage of biomarkers GFAP( Glial fibrillary acidic protein) at 4 hours for recovery of effective cardiac activity (RACS)
Determine a threshold value at H4 for recovery of effective cardiac activity (RACS) to predict membership of a homogeneous group with a favorable neurological outcome at D90.
Determine interest of combining the two biomarkers at H4 of the RACS.
Measured: at 4 hours for recovery of effective cardiac activity (RACS)
Neurological outcome at D90 assessed by modified Rankin scale (mRS) ranging from 0 to 6
Determine a threshold value at H4 for recovery of effective cardiac activity (RACS) to predict membership of a homogeneous group with a favorable neurological outcome at D90.
A score of 0 to 3 is considered a favorable neurological outcome.
Measured: 90 days after patient enrolment in the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2024
- Study start2 Feb 2025
- Primary completion31 May 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac ArrestStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 608 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06387225
- Sponsor's protocol ID
- RC23_0248
- Acronym
- HYPERION-2
- Status last verified
- Feb 2025
- First submitted
- 18 Apr 2024
- Last updated
- 26 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early and Objective Assessment of Neurological Prognosis in Cardiac Arrest Patients
- ClinicalTrials.gov ID
- NCT06387225
- Acronym / sponsor ID
- HYPERION-2 / RC23_0248
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 608 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 2 Feb 2025 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 26 Apr 2024 (actual)
- 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.
Cerebral lesions are responsible for two thirds of deaths in patients admitted to intensive care following cardiac arrest. Patients with neurological lesions should be the priority target for neuroprotective interventions, which are the cornerstone of post-cardiac arrest care (allowing a reduction in the burden of care for patients without this type of lesion). Furthermore, these interventions must be based on a precise assessment of the severity of these brain lesions: carrying out neuro-protective interventions in patients without brain lesions exposes these patients to unnecessary treatment potentially associated with adverse effects without any possible benefit. However, the early assessment of neurological prognosis, particularly on admission to intensive care, is an area where there is little research and where it is not possible to obtain a precise and reproducible assessment. Several tools can be used to assess this prognosis at an early stage: anamnesis and characteristics of the cardiac arrest and the patient's comorbidities, imaging, electrophysiology and biomarkers.
To assess the predictive value of early biomarker testing in patients resuscitated after cardiac arrest, whatever the cause, the investigators plan to conduct a prospective observational multicentre trial.
It is important to bear in mind that the aim of this study is not to assess the long-term prognosis of patients suffering cardiac arrest in order to take measures to limit or discontinue active therapies, but simply to provide a reliable tool, simple and quick to use, in order to be able to identify a sub-population of patients who should be the subject of preferential neuro-protection measures, and conversely to simplify management (moderate temperature control, early cessation of sedation, early extubation) for patients with no neurological lesions.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be included on admission to intensive care.
Key inclusion criteria (4 listed)
- Age ≥ 18 years
- Admitted to intensive care with out-of-hospital cardiac arrest
- Comatose on admission (defined by a Glasgow score ≤ 8)
- Informed relative who has consented to the patient's participation in the study or inclusion under emergency procedure if the relative is absent at the time of inclusion
Key exclusion criteria (4 listed)
- In-hospital cardiac arrest
- Age < 18 years
- Person under guardianship or legal protection
- Prior inclusion in the study
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
Dosage of biomarker UCHL-1 (Ubiquitin carboxy-terminal hydrolase L1) at the time of admission to intensive care
Time frame: at ICU admission
Determine an assay threshold value admission to the intensive care unit to predict membership of a homogeneous group with favorable neurological outcome at D90
Dosage of biomarker GFAP (Glial fibrillary acidic protein) at the time of admission to intensive care
Time frame: at ICU admission
Determine an assay threshold value admission to the intensive care unit to predict membership of a homogeneous group with favorable neurological outcome at D90
Neurological outcome at D90 assessed by modified Rankin scale (mRS)
Time frame: 90 days after patient enrolment in the study
Determine an assay threshold value admission to the intensive care unit to predict membership of a homogeneous group with favorable neurological outcome at D90
5 secondary outcomes
Dosage of biomarkers UCHL-1 ((Ubiquitin carboxy-terminal hydrolase L1) at the time of admission to intensive care
Time frame: at ICU admission
Dosage of biomarkers GFAP (Glial fibrillary acidic protein) at the time of admission to intensive care
Time frame: at ICU admission
Dosage of biomarkers UCHL-1 (Ubiquitin carboxy-terminal hydrolase L1) at 4 hours for recovery of effective cardiac activity (RACS)
Time frame: at 4 hours for recovery of effective cardiac activity (RACS)
Dosage of biomarkers GFAP( Glial fibrillary acidic protein) at 4 hours for recovery of effective cardiac activity (RACS)
Time frame: at 4 hours for recovery of effective cardiac activity (RACS)
Neurological outcome at D90 assessed by modified Rankin scale (mRS) ranging from 0 to 6
Time frame: 90 days after patient enrolment in the study
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2025.
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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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Arrest and Neurologic Symptoms, run by Nantes University Hospital at 4 sites 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 4 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: looking for participants now, as of the sponsor's last update on 26 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jean-Baptiste LASCARROU (0240087386, jeanbaptiste.lascarrou@chu-nantes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dosage of biomarker UCHL-1 (Ubiquitin carboxy-terminal hydrolase L1) at the time of admission to intensive care (time frame: at ICU admission). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Feb 2025.