Prospective Reduction Of Transplant Complications Through Enhanced Preservation Therapy to Prevent Primary Graft Dysfunction
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: Xo Port Organ Preservation System, Standard of Care - Ice packs.
- Кому может быть актуально
- Состояния в реестре: Primary Graft Dysfunction. Базовые параметры: от 17 лет · 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
- Канада
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
The goal of this clinical trial is to test the feasibility of the study protocol comparing a novel temperature control system - Xo Port Organ Preservation System - to static ice for heat preservation for Heart Transplant. The main questions of the study are as follows: Does the Incidence of severe PGD change within the first 24 hours of heart transplant in patients randomized to the Xo Port Organ Preservation System? Was there a change in composite efficacy endpoints in participants randomized to the Xo Port Organ Preservation System compared to static ice storage? Were the feasibility outcomes achieved? Were there any protocol deviations? Participants will: Be randomized to either the Xo Port Organ Preservation System or static ice storage. Complete a questionnaire at the time of screening, day 0, 7, and 90 days post transplant. Have blood drawn - with their standard of care blood draws - after their transplant, the day after, and 7 days post transplant.
Подробное описание
The PROTECT-PGD Pilot trial is a 2.5 year, 50-patient, multi-centre, feasibility, randomized, blinded, controlled pilot trial assessing feasibility of a full-scale blinded randomized controlled trial to determine whether use of the Xo Port Organ Preservation System (Traferox Technologies Inc.), a novel temperature controlled system that maintains donor heart temperature between 8 and 12°C reduces the risk of severe PGD in patients post HT. If feasibility is demonstrated, pilot trial participants will be included in the full-scale trial.
Вмешательства
- Устройство Xo Port Organ Preservation System
It is a disposable temperature-controlled hypothermic transportation system that maintains the donated heart temperature between 8 and 12°C. It consists of an insulated chamber; eutectic gel packs containing a specialized phase change material (composition under manufacturer's patent) preconditioned before use (by freezing in a 4°C temperature-regulated refrigerator for 48 hours), which maintain temperature between 8 and 12°C through passive cooling; a removable insert, a cradle to hold the orga - Устройство Standard of Care - Ice packs
Cold static donor heart preservation is currently the mainstay of organ transportation after procurement. The donor heart is placed in the Traferox Transport system with ice-packs.
Первичные конечные точки
- Primary Study Feasibility [Срок оценки: 2.5 years]
- Composite efficacy outcome of full-scare trial #1 [Срок оценки: 2.5 years]
- Composite efficacy outcome of full-scare trial #2 [Срок оценки: 2.5 years]
- Composite efficacy outcome of full-scare trial #3 [Срок оценки: 2.5 years]
- Composite efficacy outcome of full-scare trial #4 [Срок оценки: 2.5 years]
- Composite efficacy outcome of full-scare trial #5 [Срок оценки: 2.5 years]
- Composite efficacy outcome of full-scare trial #6 [Срок оценки: 2.5 years]
- Composite efficacy outcome of full-scare trial #7 [Срок оценки: 2.5 years]
- Composite efficacy outcome of full-scare trial #8 [Срок оценки: 2.5 years]
Критерии участия
Критерии включения
- Recipient: Adult (>17 years old)
- Donor: Donation after brain death acceptable for transplant as determined by a procuring physician unaware of randomization sequence at the time of acceptance
Критерии исключения
- Recipient: Multi-organ transplant recipients; Participating in an interventional study.
- Donor: Donation after cardiac death; Use of organ care system
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Тройное слепое
- Основная цель
- Другое
Центры проведения
Канада · 1 центр
- University Health Network — Toronto
Идентификаторы
NCT: NCT07230886 · 25-5039