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Exhaled Breath Particles in Lung Transplantation

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05375149
Enrollment
150
Registered
2022-05-16
Start date
2018-09-18
Completion date
2026-09-30
Last updated
2022-05-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Rejection of Lung Transplant, Lung Transplant Rejection, Primary Graft Dysfunction

Keywords

Exhaled Breath Particles, PExA, Lung transplantation, Primary Graft Dysfunction, Chronic Lug Allograft Dysfunction

Brief summary

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.

Interventions

None listed

Sponsors

Lund University Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
16 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* None

Design outcomes

Primary

MeasureTime frameDescription
Concentration of proteins in EBPPre-transplantationProteins from exhaled air are collected onto a membrane for subsequently molecular analysis. Analysis aims to identify candidate biomarker for acute and chronic rejection of transplanted lungs.
Particle flow rate from the airways (PFR)Day 1-3 after transplantationPFR will be measured by the PExA device. The flow rate and the particle pattern will be analysed to find differences between groups of lung transplanted patients with and without rejection.

Secondary

MeasureTime frameDescription
Concentration of proteins and other biomarkers in plasmaPre-transplantationConcentration and composition of proteins and other biomarkers will be analysed in plasma
Concentration of proteins and other biomarkers in BALDay 1-3 after lung transplantationConcentration and composition of proteins and other biomarkers will be analysed in BAL
Concentration of proteins and other biomarkers in lung tissueAt the time of lung transplantationConcentration and composition of proteins and other biomarkers will be analysed in lung tissue. Both taken from the native lung and from the donor lung.

Countries

Sweden

Contacts

Primary ContactSandra Lindstedt, MD, PhD
sandra.lindstedt_ingemansson@med.lu.se+46737220580

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026