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Набор по приглашению NCT07341516

Worldwide Assessment of Deceased Donor Kidney Utilization

Наблюдательное Kidney Failure Kidney Transplant Deceased Donor Kidney Transplant

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Kidney Failure, Kidney Transplant, Deceased Donor Kidney Transplant. Базовые параметры: Без ограничений · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США, Франция
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Worldwide Assessment of Deceased Donor Kidney Utilization: Disparities, Temporal Trends, and Outcomes

Обзор

The persistent imbalance between kidney transplant demand and organ availability remains a major global challenge. Optimizing the utilization of kidneys from deceased donors is a critical strategy to expand the donor pool and increase access to transplantation. Previous studies have demonstrated substantial international differences in kidney acceptance and discard practices, with significant potential gains in allograft life-years through optimized utilization. However, major changes in allocation policies, donor characteristics, preservation technologies, and global events such as the COVID-19 pandemic may have altered contemporary utilization patterns. This study aims to characterize international trends in deceased donor kidney utilization, compare allograft survival across countries, and estimate potential transplantable allograft life-years gained through improved utilization practices.

Подробное описание

Substantial imbalance between organ demand and availability remains a major challenge in kidney transplantation worldwide. Therefore, expanding the donor pool is a critical priority, and a key strategy is optimizing the utilization of organs from deceased donors. Our previous study (PMID: 31449299) demonstrated significant disparities in kidney acceptance and discard rates between US and France, with US discarding kidneys at nearly twice the rate of France. Simulation modeling suggested that adopting more aggressive, French-based acceptance practices could have prevented 17 435 discarded kidneys in the US over ten years, generating an additional 132 445 allograft life-years.

Since that period the transplantation landscape has evolved substantially. Key developments include major policy reforms such as the 2014 US Kidney Allocation System redesign, increased use of advanced preservation technologies, expanding acceptance of hepatitis C-positive donor organs, substantial growth in donation after circulatory death (DCD), and global disruptions in transplant activity caused by the COVID-19 pandemic.

The impact of these developments on current utilization practices and international disparities remains unknown. Contemporary patterns of deceased donor kidney utilization and discard rates across different allocation systems have not yet been characterized.

This study aims to:

1. Characterize international patterns and temporal trends in deceased donor kidney utilization and discard rates from 2010 to 2025. 2. Compare allograft survival across countries and donor risk profiles. 3. Quantify potential transplantable allograft life-years gained through optimized utilization practices.

Первичные конечные точки

  • Kidney allograft discard [Срок оценки: Day 0]
Вторичные конечные точки (2)
  • Allograft failure [Срок оценки: up to 15 years]
  • Estimated additional allograft life-years achievable [Срок оценки: up to 15 years]

Критерии участия

Критерии включения

  • All consecutive kidneys recovered for the purpose of transplantation from donors deceased from brain death or circulatory death between January 1, 2010 and December 31, 2025

Критерии исключения

  • Kidneys offered to transplant centers but never recovered
  • Living renal transplants
  • Multiorgan transplant recipients

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

США · 1 центр
  • Vanderbilt Center for Transplant Science, Vanderbilt University Medical Center, Nashville, — Nashville
Франция · 1 центр
  • Paris Institute for Transplantation and Organ Regeneration, INSERM, UMR-S970, Paris, Franc — Paris

Публикации

  • Aubert O, Yoo D, Zielinski D, Cozzi E, Cardillo M, Durr M, Dominguez-Gil B, Coll E, Da Silva MI, Sallinen V, Lemstrom K, Midtvedt K, Ulloa C, Immer F, Weissenbacher A, Vallant N, Basic-Jukic N, Tanabe K, Papatheodoridis G, Menoudakou G, Torres M, Soratti C, Hansen Krogh D, Lefaucheur C, Ferreira G, Silva HT Jr, Hartell D, Forsythe J, Mumford L, Reese PP, Kerbaul F, Jacquelinet C, Vogelaar S, Papal PMID 34474014
  • Loupy A, Aubert O, Reese PP, Bastien O, Bayer F, Jacquelinet C. Organ procurement and transplantation during the COVID-19 pandemic. Lancet. 2020 May 23;395(10237):e95-e96. doi: 10.1016/S0140-6736(20)31040-0. Epub 2020 May 11. No abstract available. PMID 32407668
  • Ibrahim M, Vece G, Mehew J, Johnson R, Forsythe J, Klassen D, Callaghan C, Stewart D. An international comparison of deceased donor kidney utilization: What can the United States and the United Kingdom learn from each other? Am J Transplant. 2020 May;20(5):1309-1322. doi: 10.1111/ajt.15719. Epub 2019 Dec 21. PMID 31758833
  • Vidgren M, Delorme C, Oniscu GC. Challenges and opportunities in organ donation after circulatory death. J Intern Med. 2025 Feb;297(2):124-140. doi: 10.1111/joim.20051. Epub 2025 Jan 20. PMID 39829342
  • Potluri VS, Goldberg DS, Mohan S, Bloom RD, Sawinski D, Abt PL, Blumberg EA, Parikh CR, Sharpe J, Reddy KR, Molnar MZ, Sise M, Reese PP. National Trends in Utilization and 1-Year Outcomes with Transplantation of HCV-Viremic Kidneys. J Am Soc Nephrol. 2019 Oct;30(10):1939-1951. doi: 10.1681/ASN.2019050462. Epub 2019 Sep 12. PMID 31515244
  • Bowring MG, Shaffer AA, Massie AB, Cameron A, Desai N, Sulkowski M, Garonzik-Wang J, Segev DL. Center-level trends in utilization of HCV-exposed donors for HCV-uninfected kidney and liver transplant recipients in the United States. Am J Transplant. 2019 Aug;19(8):2329-2341. doi: 10.1111/ajt.15355. Epub 2019 Apr 9. PMID 30861279
  • Hosgood SA, Callaghan CJ, Wilson CH, Smith L, Mullings J, Mehew J, Oniscu GC, Phillips BL, Bates L, Nicholson ML. Normothermic machine perfusion versus static cold storage in donation after circulatory death kidney transplantation: a randomized controlled trial. Nat Med. 2023 Jun;29(6):1511-1519. doi: 10.1038/s41591-023-02376-7. Epub 2023 May 25. PMID 37231075
  • Malinoski D, Saunders C, Swain S, Groat T, Wood PR, Reese J, Nelson R, Prinz J, Kishish K, Van De Walker C, Geraghty PJ, Broglio K, Niemann CU. Hypothermia or Machine Perfusion in Kidney Donors. N Engl J Med. 2023 Feb 2;388(5):418-426. doi: 10.1056/NEJMoa2118265. PMID 36724328

Идентификаторы

NCT: NCT07341516 · Kidney allocation project

Первоисточники (государственные реестры)

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