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RecruitingNCT06780722HEPHAISTOSUpdated Jun 25, 2026

Study of the Occurrence of Cardiocirculatory Arrest as a Function of the Level of Hypoxemia During a Maastricht 3 Procedure

An observational study in Cardiac Arrest and Reanimation, sponsored by Nantes University Hospital. Recruiting at 12 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-25.

Sponsored by Nantes University Hospital · Observational

From the registry’s dates

  • Started Dec 2025; still recruiting 9 months later.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
50
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Cardiac Arrest
  • Reanimation

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03

In context

Heart Arrest

966 studies on the registry are indexed under Heart Arrest; 227 are open to participants now.

This study's planned enrollment of 50 is below the median of 200 across 383 observational studies indexed under Heart Arrest.

Browse Heart Arrest studies →

Lead sponsor

Nantes University Hospital is the lead sponsor of 825 studies on the registry; 195 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Eligibility criteria

FOR THE DONORS :

Inclusion Criteria :

  • 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

Exclusion Criteria :

  • 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

Inclusion Criteria :

  • 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

Exclusion Criteria :

- Patients under guardianship, curatorship or legal protection

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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
50 participants (estimated)
Patient registry
No

Interventions

  • Otherblood 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.

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: 24 hours

Secondary outcomes

  1. Spo2 Level

    Define the level of Spo2 (and its 95% confidence interval) at the time of cardiocirculatory arrest during a Maastricht III procedure.

    Time frame: 24 hours

  2. 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.

    Time frame: 24 hours

  3. 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.

    Time frame: 7 days

07

Study locations

11 of 12 sites recruiting
  • CHU ANGERS - Réanimation médicale
    Angers, France
    Recruiting
  • CH ANNECY GENEVOIS - Réanimation médicale - Coordination Prélèvements multi-organes
    Annecy, France
    Recruiting
  • CH AVIGNON - CH Henri Duffaut - Réanimation polyvalente
    Avignon, France
    Recruiting
  • CHD Vendée - Les Oudairies - Médecine Intensive Réanimation
    La Roche-sur-Yon, France
    Recruiting
  • CHU LILLE - Hôpital Roger Salengro - Médecine Intensive Réanimation
    Lille, France
    Recruiting
  • CHU de Nantes - Hôpital Laennec
    Nantes, France
    Recruiting
  • CHU NANTES +- Médecine Intensive Réanimation
    Nantes, France
    Recruiting
  • CHRU ORLEANS -Médecine Intensive Réanimation - Coordination Prélèvements multi-organes
    Orléans, France
    Recruiting
  • CHU POITIERS - Anesthésie Réanimation - Coordination Prélèvements multi-organes
    Poitiers, France
    Not yet recruiting
  • CHU RENNES - CHU Pontchaillou - Réanimation médicale
    Rennes, France
    Recruiting
  • CHRU TOURS - Hôpital Bretonneau - Médecine Intensive Réanimation
    Tours, France
    Recruiting
  • CHBA Vannes-Auray - Réanimation Polyvalente
    Vannes, France
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 25, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06780722
Lead sponsor
Nantes University Hospital
Responsible party
Sponsor
First posted
Jan 17, 2025
Start date
Dec 19, 2025
Primary completion
Jun 6, 2027 (estimated)
Completion
Jun 19, 2027 (estimated)
Last update
Jun 25, 2026

Study contacts

Jean Baptiste LASCARROU
Contact
Jeanbaptiste.lascarrou@chu-nantes.fr
02 40 08 73 76 ext. +33

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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