Набор по приглашению NCT04930289

Global Utilization And Registry Database for Improved preservAtion of doNor LUNGs

— Наблюдательное Interstitial Lung Disease COPD Cystic Fibrosis Pulmonary Fibrosis

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: В протоколе указаны: LungGuard, BAROGuard.
Кому может быть актуально: Состояния в реестре: Interstitial Lung Disease, COPD, Cystic Fibrosis, Pulmonary Fibrosis. 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, Бельгия
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Global Utilization and Registry Database for Improved Preservation of Donor Lungs

Обзор

The objective of this registry is to collect and evaluate various clinical effectiveness parameters in patients with transplanted donor lung that were preserved and transported within the LUNGguard system, as well as retrospective standard of care patients

Подробное описание

GUARDIAN-Lung is a post-market, observational registry of adult and pediatric lung transplant recipient patients whose donor lungs was preserved and transported within the LUNGguard. The data is being collected retrospectively from medical records of patients already transplanted before the initiation of the registry and any new patients who meet the eligibility criteria.

About 500 male and female subjects (including pediatric patients) meeting the study inclusion and exclusion criteria will be enrolled into the study at about 5 clinical sites.

Candidates that fit the eligibility criteria and have had their donor lungs transported with a Paragonix product or a standard of care method can be enrolled. The baseline characteristics and outcomes of the two groups will be compared.

Вмешательства

Устройство LungGuard
The LUNGguard is an FDA cleared and is a CE-marked medical device intended to be used for the static hypothermic preservation of lungs during transportation and eventual transplantation into a recipient using cold storage solutions indicated for use with the lungs. The intended organ storage time for the LUNGguard is up to 8 hours.
Устройство BAROGuard
The BAROguard (the "System") is ultraportable hypothermic preservation and transport system intended for use with donor lungs. BAROguard is a legally marketed, FDA cleared medical device in the United States. The intended organ storage time for BAROguard™ is up to 8 hours.

Первичные конечные точки

Number of subjects with Primary Graft Dysfunction (PGD) [Срок оценки: Post-transplant through 1 year post]
Number of subjects with rejection [Срок оценки: Post-transplant through 1 year post]
Survival [Срок оценки: Post-transplant through 1 year post]
ICU Length of Stay [Срок оценки: Transplant through 1 year post-transplant]
Hospital Length of Stay [Срок оценки: Transplant through 1 year post-transplant]

Вторичные конечные точки (2)

Number of rehospitalizations [Срок оценки: post-transplant through 1 year]
How long subjects needed mechanical support [Срок оценки: pre-transplant through 48 hours post-transplant]

Критерии участия

Критерии включения

Donor and donor lungs matched to the prospective recipient based upon institutional medical practice
Registered male or female primary lung transplant candidates including pediatric candidates

Критерии исключения

Donor and donor lungs that do not meet institutional clinical requirements for transplantation
Patients who are incarcerated persons (prisoners)
Patients who have had a previous major organ transplant (heart, lungs, liver, kidney, pancreas)
Patients who are receiving multiple organ transplants

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

Здоровые добровольцы: Нет