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Идёт набор NCT05375149

Exhaled Breath Particles in Lung Transplantation

— Наблюдательное Lung Transplant Rejection Primary Graft Dysfunction Chronic Rejection of Lung Transplant

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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: Lung Transplant Rejection, Primary Graft Dysfunction, Chronic Rejection of Lung Transplant. Базовые параметры: 16 лет — 75 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
Швеция
Следующий шаг
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Официальное название

Exhaled Breath Particles as a Clinical Indicator for Acute and Chronic Rejection After Lung Transplantation

Обзор

Lung transplantation (LTx) is the only effective treatment for patients with end stage lung disease. Of the major organs transplanted, survival following LTx is the lowest with a mean of 5 years. Despite improvements, primary graft dysfunction (PGD) remains the leading cause of early mortality and contributes to the development of chronic lung allograft dysfunction (CLAD) that remains the leading cause of late mortality. Earlier detection of rejection after LTx is of substantial importance as it would improve the possibilities of treatment and could increase survival. The investigators have shown in previous work that exhaled breath particles (EBP) reflect the composition of respiratory tract lining fluid (RTLF). EBP and particle flow rate (PFR) can be used as non-invasive methods for early detection and monitoring of airway diseases such as acute respiratory distress syndrome (ARDS). It has also been shown that the particle flow prolife after lung transplantation differs between patients who develop PGD and those who do not and that the composition of EBP differs between patients with and without bronchiolitis obliterans syndrome (BOS), an obstructive form of CLAD. Samples of EBP and measurements of PFR will be collected from lung transplanted patients. Membranes with EBP will be saved for molecular analysis. The investigators aim to identify potential particle flow patterns and biomarkers for earlier detection of rejection after lung transplantation.

Подробное описание

Samples of EBP and measurement of PFR will be done on patients undergoing lung transplantation at Skåne University Hospital (SUS) Lund. Measurements of EBP and PFR and collection of blood will be done repeatedly postoperatively when the patient is still in the hospital, at three months post-transplantation, at six months post-transplantation, at 12 months post-transplantation and annually after that. An additional preoperative blood sample will also be obtained. Furthermore, the investigators will collect bronchoalveolar lavage fluid (BALF) and lung biopsies when the patient is scheduled for routine bronchoscopies in the follow-up period.

This study involves measurements of EBP and PFR done by the particles in exhaled air (PExA) system on lung transplanted patients with and without acute or chronic rejection. The patients who do not develop any form of rejection will serve as a control group to the ones who develop rejection. Furthermore, each patient will serve as their own control.

The purpose of this study is to find better means of identifying rejection of transplanted lungs in earlier stages, and to explore candidate biomarkers. Earlier diagnosis of rejection of the transplanted organ can lead to better treatment possibilities and a positive impact on survival after LTx.

Первичные конечные точки

  • Concentration of proteins in EBP [Срок оценки: Pre-transplantation]
  • Concentration of proteins in EBP [Срок оценки: Day 1-3 after lung transplantation]
  • Concentration of proteins in EBP [Срок оценки: 1 month after lung transplantation]
  • Concentration of proteins in EBP [Срок оценки: 3 months after lung transplantation]
  • Concentration of proteins in EBP [Срок оценки: 6 months after lung transplantation]
  • Concentration of proteins in EBP [Срок оценки: 9 months after lung transplantation]
  • Concentration of proteins in EBP [Срок оценки: 12 months after lung transplantation]
  • Concentration of proteins in EBP [Срок оценки: 18 months after lung transplantation]
  • Concentration of proteins in EBP [Срок оценки: 2 years after lung transplantation]
  • Concentration of proteins in EBP [Срок оценки: 3 years after lung transplantation]
Вторичные конечные точки (12)
  • Concentration of proteins and other biomarkers in plasma [Срок оценки: Pre-transplantation]
  • Concentration of proteins and other biomarkers in plasma [Срок оценки: Day 1 after lung transplantation]
  • Concentration of proteins and other biomarkers in plasma [Срок оценки: Day 2 after lung transplantation]
  • Concentration of proteins and other biomarkers in plasma [Срок оценки: Day 3 after lung transplantation]
  • Concentration of proteins and other biomarkers in plasma [Срок оценки: 1 month after lung transplantation]
  • Concentration of proteins and other biomarkers in plasma [Срок оценки: 3 months after lung transplantation]
  • Concentration of proteins and other biomarkers in plasma [Срок оценки: 6 months after lung transplantation]
  • Concentration of proteins and other biomarkers in plasma [Срок оценки: 9 months after lung transplantation]
  • Concentration of proteins and other biomarkers in plasma [Срок оценки: 12 months after lung transplantation]
  • Concentration of proteins and other biomarkers in plasma [Срок оценки: 18 months after lung transplantation]
  • Concentration of proteins and other biomarkers in plasma [Срок оценки: 2 years after lung transplantation]
  • Concentration of proteins and other biomarkers in plasma [Срок оценки: 3 years after lung transplantation]

Критерии участия

Критерии включения

  • Patients who have undergone LTx at Skåne University Hospital, SUS Lund

Критерии исключения

  • None

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Случай-контроль

Центры проведения

Швеция · 1 центр
  • Skåne University Hospital — Lund

Публикации

  • Ericson PA, Mirgorodskaya E, Hammar OS, Viklund EA, Almstrand AR, Larsson PJ, Riise GC, Olin AC. Low Levels of Exhaled Surfactant Protein A Associated With BOS After Lung Transplantation. Transplant Direct. 2016 Aug 26;2(9):e103. doi: 10.1097/TXD.0000000000000615. eCollection 2016 Sep. PMID 27795995
  • Stenlo M, Hyllen S, Silva IAN, Bolukbas DA, Pierre L, Hallgren O, Wagner DE, Lindstedt S. Increased particle flow rate from airways precedes clinical signs of ARDS in a porcine model of LPS-induced acute lung injury. Am J Physiol Lung Cell Mol Physiol. 2020 Mar 1;318(3):L510-L517. doi: 10.1152/ajplung.00524.2019. Epub 2020 Jan 29. PMID 31994907
  • Broberg E, Hyllen S, Algotsson L, Wagner DE, Lindstedt S. Particle Flow Profiles From the Airways Measured by PExA Differ in Lung Transplant Recipients Who Develop Primary Graft Dysfunction. Exp Clin Transplant. 2019 Dec;17(6):803-812. doi: 10.6002/ect.2019.0187. Epub 2019 Oct 11. PMID 31615381
  • Behndig AF, Mirgorodskaya E, Blomberg A, Olin AC. Surfactant Protein A in particles in exhaled air (PExA), bronchial lavage and bronchial wash - a methodological comparison. Respir Res. 2019 Sep 26;20(1):214. doi: 10.1186/s12931-019-1172-1. PMID 31558154

Идентификаторы

NCT: NCT05375149 · LTxPEx

Первоисточники (государственные реестры)

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