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NCT Number: NCT06780722

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

Evaluation of the level of hypoxemia during the occurrence of cardiocirculatory arrest during a Maastricht III organ donation procedure.

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Key information

Conditions

Cardiac Arrest Cardiovascular Diseases Heart Arrest Heart Diseases Reanimation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU ANGERS - Réanimation médicale, Angers, France

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About this study

Evaluation of the level of hypoxemia during the occurrence of cardiocirculatory arrest during a Maastricht III organ donation procedure.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood sampling

Other
  • 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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Spo2 Level

    Time frame: 24 hours

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

  2. Time between occurrence of first episode of pulsed oxygen saturation below 95% and onset of cardiocirculatory arrest

    Time frame: 24 hours

    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.

  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.

    Time frame: 7 days

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jean Baptiste LASCARROU

CONTACT

[email protected]

02 40 08 73 76 ext. +33

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Official study 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

Acronym: HEPHAISTOS

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jan 17, 2025
Registry last updated
Jun 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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