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Recruiting NCT05375149

Exhaled Breath Particles in Lung Transplantation

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

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Lung Transplant Rejection, Primary Graft Dysfunction, Chronic Rejection of Lung Transplant. Basic parameters: 16 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Sweden
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Detailed description

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.

Primary outcome measures

  • Concentration of proteins in EBP [Time frame: Pre-transplantation]
  • Concentration of proteins in EBP [Time frame: Day 1-3 after lung transplantation]
  • Concentration of proteins in EBP [Time frame: 1 month after lung transplantation]
  • Concentration of proteins in EBP [Time frame: 3 months after lung transplantation]
  • Concentration of proteins in EBP [Time frame: 6 months after lung transplantation]
  • Concentration of proteins in EBP [Time frame: 9 months after lung transplantation]
  • Concentration of proteins in EBP [Time frame: 12 months after lung transplantation]
  • Concentration of proteins in EBP [Time frame: 18 months after lung transplantation]
  • Concentration of proteins in EBP [Time frame: 2 years after lung transplantation]
  • Concentration of proteins in EBP [Time frame: 3 years after lung transplantation]
Secondary outcome measures (12)
  • Concentration of proteins and other biomarkers in plasma [Time frame: Pre-transplantation]
  • Concentration of proteins and other biomarkers in plasma [Time frame: Day 1 after lung transplantation]
  • Concentration of proteins and other biomarkers in plasma [Time frame: Day 2 after lung transplantation]
  • Concentration of proteins and other biomarkers in plasma [Time frame: Day 3 after lung transplantation]
  • Concentration of proteins and other biomarkers in plasma [Time frame: 1 month after lung transplantation]
  • Concentration of proteins and other biomarkers in plasma [Time frame: 3 months after lung transplantation]
  • Concentration of proteins and other biomarkers in plasma [Time frame: 6 months after lung transplantation]
  • Concentration of proteins and other biomarkers in plasma [Time frame: 9 months after lung transplantation]
  • Concentration of proteins and other biomarkers in plasma [Time frame: 12 months after lung transplantation]
  • Concentration of proteins and other biomarkers in plasma [Time frame: 18 months after lung transplantation]
  • Concentration of proteins and other biomarkers in plasma [Time frame: 2 years after lung transplantation]
  • Concentration of proteins and other biomarkers in plasma [Time frame: 3 years after lung transplantation]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

  • None

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-control

Study locations

Sweden · 1 center
  • Skåne University Hospital — Lund

Publications

  • 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

Identifiers

NCT: NCT05375149 · LTxPEx

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗