Cardiac ArrestHEPHAISTOSNCT06780722
Study of the Occurrence of Cardiocirculatory Arrest as a Function of the Level of Hypoxemia During a Maastricht 3 Procedure
An observational study of Cardiac Arrest and Reanimation, run by Nantes University Hospital at 12 sites in France.
Trial summary
Evaluation of the level of hypoxemia during the occurrence of cardiocirculatory arrest during a Maastricht III organ donation procedure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Arrest, Reanimation
- What is being tested?
- blood sampling
- How many people
- 50 participants
- Where
- 12 sitesFrance
- Study dates
- 19 Dec 2025to 19 Jun 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 who may be candidates for an organ donation procedure in the event of death in intensive care following the implementation of a procedure to discontinue active therapies.
Who may be able to join
- Patient over 18 years of age
- Organ donation procedure initiated in accordance with the legislation and procedures in force in France for the Maastricht III category
- No opposition formulated by the relative to the patient's participation in the study
- No opposition to the collection of data concerning him/her
- Patient over 18 at pre-transplant consultation
- Patient who has received an organ from a donor participating in the HEPHAISTOS protocol
Who cannot join
- Patient registered on the national register of refusals or living refusal of donation
- Pregnant or breast-feeding women
- Patients under guardianship, curatorship or legal protection
- Medical contraindication to organ donation according to the recommendations of the Agence de Biomédecine currently in force in France
- FOR THE RECEIVER
- Patients under guardianship, curatorship or legal protection
Trial locations and contacts
12 sites in 1 country. Contact the study team or a site near you to ask about taking part.
12 sites in 1 country
France12 sites, 12 recruiting
- Recruiting
CHU ANGERS - Réanimation médicale
Angers
Mathieu CONTE, 02 41 35 38 15 ext. +33, MaConte@chu-angers.fr
- Recruiting
CH ANNECY GENEVOIS - Réanimation médicale - Coordination Prélèvements multi-organes
Annecy
Didier DOREZ, 04 50 63 65 60 ext. +33, ddorez@ch-annecygenevois.fr
- Recruiting
CH AVIGNON - CH Henri Duffaut - Réanimation polyvalente
Avignon
Gael PRADEL, 04 32 75 34 61 ext. +33, pradel.gael@ch-avignon.fr
- Recruiting
CHD Vendée - Les Oudairies - Médecine Intensive Réanimation
La Roche-sur-Yon
Marie-Ange AZAIS, 02 51 44 62 12 ext. +33, marie-ange.azais@ght85.fr
- Recruiting
CHU LILLE - Hôpital Roger Salengro - Médecine Intensive Réanimation
Lille
Côme BUREAU, 03 20 44 40 84 ext. +33, come.bureau@chu-lille.fr
- Recruiting
CHU de Nantes - Hôpital Laennec
Nantes
Alice ROUILLARD, PH, 0240185489, alice.rouillard@chu-nantes.fr
- Recruiting
CHU NANTES +- Médecine Intensive Réanimation
Nantes
Jean-Baptiste LASCARROU, 02 40 08 73 86 ext. +33, jeanbaptiste.lascarrou@chu-nantes.fr
- Recruiting
CHRU ORLEANS -Médecine Intensive Réanimation - Coordination Prélèvements multi-organes
Orléans
Anne BRETAGNOL, 02 38 51 44 44 ext. +33, anne.bretagnol@chu-orleans.fr
- Not yet recruiting
CHU POITIERS - Anesthésie Réanimation - Coordination Prélèvements multi-organes
Poitiers
Thomas KERFORNE, 05 49 44 46 35 ext. +33, thomas.kerforne@chu-poitiers.fr
- Recruiting
CHU RENNES - CHU Pontchaillou - Réanimation médicale
Rennes
Sonia ISSLAME, 02 99 28 42 46 ext. +33, sonia.isslame@chu-rennes.fr
- Recruiting
CHRU TOURS - Hôpital Bretonneau - Médecine Intensive Réanimation
Tours
Jean-Christophe VENHARD, 02 18 37 08 37 ext. +33, jc.venhard@chu-tours.fr
- Recruiting
CHBA Vannes-Auray - Réanimation Polyvalente
Vannes
Agathe DELBOVE, 02 97 01 43 06 ext. +33, agathe.delbove@ch-bretagne-atlantique.fr
About this study
Official title: Study of the Occurrence of Cardiocirculatory Arrest as a Function of the Level of Hypoxemia During a Maastricht 3 Procedure. Prospective Observational Multicenter Study
Evaluation of the level of hypoxemia during the occurrence of cardiocirculatory arrest during a Maastricht III organ donation procedure.
Read the detailed description
Evaluation of the level of hypoxemia during the occurrence of cardiocirculatory arrest during a Maastricht III organ donation procedure.
- Conditions
- Cardiac Arrest, Reanimation
- Being tested
- blood sampling
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood samplingOther
- The first sample is taken at the start of the therapeutic stop.
- The second sample is taken when the mean arterial pressure drops to 45mmHg.
- The third sample is taken when circulatory arrest occurs.
- The fourth sample is taken at the start of extracorporeal circulation. These four samples will be destroyed at the end of the study.
What is being measured
The primary outcome is the main question the study is designed to answer.
PaO2 level
PaO2 level and its 95% confidence interval in the event of circulatory cardiac arrest, defined as a pulse pressure below 5 mmHg, during a Maastricht III procedure.
Measured: 24 hours
Secondary outcomes (3)
Spo2 Level
Define the level of Spo2 (and its 95% confidence interval) at the time of cardiocirculatory arrest during a Maastricht III procedure.
Measured: 24 hours
Time between occurrence of first episode of pulsed oxygen saturation below 95% and onset of cardiocirculatory arrest
Define the time (and its 95% confidence interval) between the occurrence of the first first episode of pulsed oxygen saturation below 95% and the onset of cardio-circulatory arrest defined by absence of pulsed pressure below 5 mmHg.
Measured: 24 hours
Correlation between the rate of delayed recovery of renal function in the recipient and the presence of hypoxemia at the time of cardiocirculatory arrest in the donor.
Delayed recovery of renal function will be confirmed if the recipient undergoes dialysis within the first 7 days after transplantation. Hypoxemia is defined as a PaO2 less than or equal to the median value.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2025
- Study start19 Dec 2025
- Primary completion6 Jun 2027 (estimated)
- Study completion19 Jun 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 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
- NCT06780722
- Sponsor's protocol ID
- RC22_0498
- Acronym
- HEPHAISTOS
- Status last verified
- Jun 2026
- First submitted
- 13 Jan 2025
- Last updated
- 25 Jun 2026
- 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 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Occurrence of Cardiocirculatory Arrest as a Function of the Level of Hypoxemia During a Maastricht 3 Procedure. Prospective Observational Multicenter Study
- ClinicalTrials.gov ID
- NCT06780722
- Acronym / sponsor ID
- HEPHAISTOS / RC22_0498
- Conditions
- Cardiac Arrest, Reanimation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 19 Dec 2025 (actual)
- Primary completion
- 6 Jun 2027 (estimated)
- Study completion
- 19 Jun 2027 (estimated)
- First posted
- 17 Jan 2025 (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.
Evaluation of the level of hypoxemia during the occurrence of cardiocirculatory arrest during a Maastricht III organ donation procedure.
Detailed description
Evaluation of the level of hypoxemia during the occurrence of cardiocirculatory arrest during a Maastricht III organ donation procedure.
Study design
- Observational model
- Case only
- 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 who may be candidates for an organ donation procedure in the event of death in intensive care following the implementation of a procedure to discontinue active therapies.
Key inclusion criteria (6 listed)
- Patient over 18 years of age
- Organ donation procedure initiated in accordance with the legislation and procedures in force in France for the Maastricht III category
- No opposition formulated by the relative to the patient's participation in the study
- No opposition to the collection of data concerning him/her
- Patient over 18 at pre-transplant consultation
Key exclusion criteria (6 listed)
- Patient registered on the national register of refusals or living refusal of donation
- Pregnant or breast-feeding women
- Patients under guardianship, curatorship or legal protection
- Medical contraindication to organ donation according to the recommendations of the Agence de Biomédecine currently in force in France
- FOR THE RECEIVER
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood sampling* The first sample is taken at the start of the therapeutic stop. * The second sample is taken when the mean arterial pressure drops to 45mmHg. * The third sample is taken when circulatory arrest occurs. * The fourth sample is taken at the start of extracorporeal circulation. These four samples will be destroyed at the end of the study. | Other | – |
Primary outcome
PaO2 level
Time frame: 24 hours
PaO2 level and its 95% confidence interval in the event of circulatory cardiac arrest, defined as a pulse pressure below 5 mmHg, during a Maastricht III procedure.
3 secondary outcomes
Spo2 Level
Time frame: 24 hours
Time between occurrence of first episode of pulsed oxygen saturation below 95% and onset of cardiocirculatory arrest
Time frame: 24 hours
Correlation between the rate of delayed recovery of renal function in the recipient and the presence of hypoxemia at the time of cardiocirculatory arrest in the donor.
Time frame: 7 days
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 25 Jun 2026.
Related trials for Cardiac Arrest
RecruitingObservational study
AI-powered ECG Analysis Using Willem™ Software in High-risk Cardiac Patients (WILLEM)
Cardiomyopathies, Cardiac Arrest
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruitingObservational study
CAROTID DOPPLER AND CEREBRAL OXIMERY IN POST CARDIAC ARREST ICU PATIENTS
Cardiac Arrest (CA), Carotid Doppler
Active, not recruitingPhase 3
The Danish Out-of-Hospital Cardiac Arrest Study
Out-Of-Hospital Cardiac Arrest, Post-Cardiac Arrest Syndrome
RecruitingObservational study
Evaluation of Acid-base Disorders and Ventilation Settings in Cardiogenic Shock and Post-cardiac Arrest Patients: Comparison With VentilO Algorithm
Cardiac Arrest (CA), Cardiogenic Shock
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.
12 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 Reanimation, run by Nantes University Hospital at 12 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 6 inclusion and 6 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 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 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 (02 40 08 73 76 ext. +33, 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?
PaO2 level (time frame: 24 hours). 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 25 Jun 2026.