ICU Management of Brain-Dead Donors Before Multi-Organ Procurement and Factors Associated With the Number of Organs Retrieved

NCT ID: NCT06768515

Last Updated: 2025-05-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-04-23

Study Completion Date

2026-02-15

Brief Summary

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Solid organ transplantation is the treatment of choice for end stage organ failure to improve patients' quality of life and survival. Each year, more than 5,000 solid organ transplants are performed in France, mainly from brain death donors (BDD).

Approximately 1,500 BDD donors have one or more organs removed each year. Despite the growing demand for transplanted organs, the number of organs available from deceased donors has remained stable over the past few decades. This highlights the need to optimize the management of potential BDD, in order to increase both the quality and number of transplanted organs. Several studies have found an association between the characteristics and management of BDD donors and the number of organs, or even the function of transplanted organs. Data suggest that hemodynamic, respiratory, and metabolic therapeutic targets during BDD management prior to multi-organ procurement were associated with a higher number of transplanted organs compared to standard care. However, this has never been confirmed in a French population. Furthermore, while the impact of these therapeutic goals has been studied after the donor is in a state of brain death, the events occurring in the ICU before reaching brain death status and their impact on the number of organs retrieved have not been investigated. Lastly, the intensity of the therapeutic interventions used to achieve these goals, and certain management delays, have only been partially studied.

Our hypothesis is that achieving a bundle of therapeutic goals, and the intensity of the interventions used to reach these goals, both before and after BDD, are associated with a greater number of organs retrieved.

Detailed Description

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Conditions

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Death, Brain

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Organ donation

Patients over 18 years of age, hospitalized in the ICU In a state of brain death No objection to organ donation during their lifetime

No interventtion

Intervention Type OTHER

to enhance the understanding of the factors associated with the number of organs retrieved from patients admitted to the ICU for organ donation

Interventions

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No interventtion

to enhance the understanding of the factors associated with the number of organs retrieved from patients admitted to the ICU for organ donation

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients over 18 years of age, hospitalized in the ICU
* In a state of brain death
* No objection to organ donation during their lifetime
* Patients with social security coverage

Exclusion Criteria

* Objection to the use of their data during their lifetime
* Registration in the national refusal registry
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Société Française d'Anesthésie et de Réanimation

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hôpital Saint-Louis, AP-HP

Paris, , France

Site Status NOT_YET_RECRUITING

Hôpital Pitié Salpêtrière AP-HP

Paris, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Maxime COUTROT, MD

Role: CONTACT

+33 1 42 49 93 94

François DEPRET, MD

Role: CONTACT

+33 1 42 49 93 94

Facility Contacts

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Maxime COUTROT, MD

Role: primary

Frank Ferrari, MD

Role: primary

References

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Malinoski DJ, Patel MS, Daly MC, Oley-Graybill C, Salim A; UNOS Region 5 DMG workgroup. The impact of meeting donor management goals on the number of organs transplanted per donor: results from the United Network for Organ Sharing Region 5 prospective donor management goals study. Crit Care Med. 2012 Oct;40(10):2773-80. doi: 10.1097/CCM.0b013e31825b252a.

Reference Type BACKGROUND
PMID: 22846779 (View on PubMed)

Oniscu GC, Rockell K, Martin DE. Challenges in undertaking research in transplantation. Lancet. 2025 Mar 1;405(10480):681-683. doi: 10.1016/S0140-6736(24)00931-0. Epub 2024 May 21. No abstract available.

Reference Type BACKGROUND
PMID: 38788740 (View on PubMed)

iomedecine, P. Chiffres 2022 de l'activité de prélèvement et de greffe d'organes et de tissus et Baromète 2023 sur la connaissance et la perception du don d'organes en France.

Reference Type BACKGROUND

Patel MS, De La Cruz S, Sally MB, Groat T, Malinoski DJ. Active Donor Management During the Hospital Phase of Care Is Associated with More Organs Transplanted per Donor. J Am Coll Surg. 2017 Oct;225(4):525-531. doi: 10.1016/j.jamcollsurg.2017.06.014. Epub 2017 Jul 21.

Reference Type RESULT
PMID: 28739153 (View on PubMed)

Bera KD, Shah A, English MR, Harvey D, Ploeg RJ. Optimisation of the organ donor and effects on transplanted organs: a narrative review on current practice and future directions. Anaesthesia. 2020 Sep;75(9):1191-1204. doi: 10.1111/anae.15037. Epub 2020 May 19.

Reference Type RESULT
PMID: 32430910 (View on PubMed)

Patel MS, Zatarain J, De La Cruz S, Sally MB, Ewing T, Crutchfield M, Enestvedt CK, Malinoski DJ. The impact of meeting donor management goals on the number of organs transplanted per expanded criteria donor: a prospective study from the UNOS Region 5 Donor Management Goals Workgroup. JAMA Surg. 2014 Sep;149(9):969-75. doi: 10.1001/jamasurg.2014.967.

Reference Type RESULT
PMID: 25054379 (View on PubMed)

Other Identifiers

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2024-04

Identifier Type: -

Identifier Source: org_study_id

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