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NCT Number: NCT05375149

Exhaled Breath Particles in Lung Transplantation

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.

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Key information

Conditions

Lung Transplant Rejection Cardiovascular Diseases Chronic Rejection of Lung Transplant Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Primary Graft Dysfunction Reperfusion Injury Vascular Diseases

Age range

16 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Skåne University Hospital

Lund, Skåne County, 224 60, Sweden

Location status: Recruiting

Location contact

Sandra Lindstedt, MD, PhD

CONTACT

[email protected]

0737220580

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • None

Treatment and study plan

Primary outcomes

  1. Concentration of proteins in EBP

    Time frame: Pre-transplantation

    Proteins 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.

  2. Concentration of proteins in EBP

    Time frame: Day 1-3 after lung transplantation

    Proteins 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.

  3. Concentration of proteins in EBP

    Time frame: 1 month after lung transplantation

    Proteins 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.

  4. Concentration of proteins in EBP

    Time frame: 3 months after lung transplantation

    Proteins 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.

  5. Concentration of proteins in EBP

    Time frame: 6 months after lung transplantation

    Proteins 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.

  6. Concentration of proteins in EBP

    Time frame: 9 months after lung transplantation

    Proteins 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.

  7. Concentration of proteins in EBP

    Time frame: 12 months after lung transplantation

    Proteins 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.

  8. Concentration of proteins in EBP

    Time frame: 18 months after lung transplantation

    Proteins 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.

  9. Concentration of proteins in EBP

    Time frame: 2 years after lung transplantation

    Proteins 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.

  10. Concentration of proteins in EBP

    Time frame: 3 years after lung transplantation

    Proteins 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.

  11. Concentration of proteins in EBP

    Time frame: 4 years after lung transplantation

    Proteins 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.

  12. Particle flow rate from the airways (PFR)

    Time frame: Day 1-3 after transplantation

    PFR 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.

  13. Particle flow rate from the airways (PFR)

    Time frame: 1 month after transplantation

    PFR 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.

  14. Particle flow rate from the airways (PFR)

    Time frame: 3 months after transplantation

    PFR 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.

  15. Particle flow rate from the airways (PFR)

    Time frame: 6 months after transplantation

    PFR 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.

  16. Particle flow rate from the airways (PFR)

    Time frame: 9 months after transplantation

    PFR 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.

  17. Particle flow rate from the airways (PFR)

    Time frame: 12 months after transplantation

    PFR 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.

  18. Particle flow rate from the airways (PFR)

    Time frame: 18 months after transplantation

    PFR 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.

  19. Particle flow rate from the airways (PFR)

    Time frame: 2 years after transplantation

    PFR 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.

  20. Particle flow rate from the airways (PFR)

    Time frame: 3 years after transplantation

    PFR 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.

  21. Particle flow rate from the airways (PFR)

    Time frame: 4 years after transplantation

    PFR 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 outcomes

  1. Concentration of proteins and other biomarkers in plasma

    Time frame: Pre-transplantation

    Concentration and composition of proteins and other biomarkers will be analysed in plasma

  2. Concentration of proteins and other biomarkers in plasma

    Time frame: Day 1 after lung transplantation

    Concentration and composition of proteins and other biomarkers will be analysed in plasma

  3. Concentration of proteins and other biomarkers in plasma

    Time frame: Day 2 after lung transplantation

    Concentration and composition of proteins and other biomarkers will be analysed in plasma

  4. Concentration of proteins and other biomarkers in plasma

    Time frame: Day 3 after lung transplantation

    Concentration and composition of proteins and other biomarkers will be analysed in plasma

  5. Concentration of proteins and other biomarkers in plasma

    Time frame: 1 month after lung transplantation

    Concentration and composition of proteins and other biomarkers will be analysed in plasma

  6. Concentration of proteins and other biomarkers in plasma

    Time frame: 3 months after lung transplantation

    Concentration and composition of proteins and other biomarkers will be analysed in plasma

  7. Concentration of proteins and other biomarkers in plasma

    Time frame: 6 months after lung transplantation

    Concentration and composition of proteins and other biomarkers will be analysed in plasma

  8. Concentration of proteins and other biomarkers in plasma

    Time frame: 9 months after lung transplantation

    Concentration and composition of proteins and other biomarkers will be analysed in plasma

  9. Concentration of proteins and other biomarkers in plasma

    Time frame: 12 months after lung transplantation

    Concentration and composition of proteins and other biomarkers will be analysed in plasma

  10. Concentration of proteins and other biomarkers in plasma

    Time frame: 18 months after lung transplantation

    Concentration and composition of proteins and other biomarkers will be analysed in plasma

  11. Concentration of proteins and other biomarkers in plasma

    Time frame: 2 years after lung transplantation

    Concentration and composition of proteins and other biomarkers will be analysed in plasma

  12. Concentration of proteins and other biomarkers in plasma

    Time frame: 3 years after lung transplantation

    Concentration and composition of proteins and other biomarkers will be analysed in plasma

  13. Concentration of proteins and other biomarkers in plasma

    Time frame: 4 years after lung transplantation

    Concentration and composition of proteins and other biomarkers will be analysed in plasma

  14. Concentration of proteins and other biomarkers in BAL

    Time frame: Day 1-3 after lung transplantation

    Concentration and composition of proteins and other biomarkers will be analysed in BAL

  15. Concentration of proteins and other biomarkers in BAL

    Time frame: 1 month after lung transplantation

    Concentration and composition of proteins and other biomarkers will be analysed in BAL

  16. Concentration of proteins and other biomarkers in BAL

    Time frame: 3 months after lung transplantation

    Concentration and composition of proteins and other biomarkers will be analysed in BAL

  17. Concentration of proteins and other biomarkers in BAL

    Time frame: 6 months after lung transplantation

    Concentration and composition of proteins and other biomarkers will be analysed in BAL

  18. Concentration of proteins and other biomarkers in BAL

    Time frame: 9 months after lung transplantation

    Concentration and composition of proteins and other biomarkers will be analysed in BAL

  19. Concentration of proteins and other biomarkers in BAL

    Time frame: 12 months after lung transplantation

    Concentration and composition of proteins and other biomarkers will be analysed in BAL

  20. Concentration of proteins and other biomarkers in BAL

    Time frame: 18 months after lung transplantation

    Concentration and composition of proteins and other biomarkers will be analysed in BAL

  21. Concentration of proteins and other biomarkers in BAL

    Time frame: 2 years after lung transplantation

    Concentration and composition of proteins and other biomarkers will be analysed in BAL

  22. Concentration of proteins and other biomarkers in BAL

    Time frame: 3 years after lung transplantation

    Concentration and composition of proteins and other biomarkers will be analysed in BAL

  23. Concentration of proteins and other biomarkers in BAL

    Time frame: 4 years after lung transplantation

    Concentration and composition of proteins and other biomarkers will be analysed in BAL

  24. Concentration of proteins and other biomarkers in lung tissue

    Time frame: At the time of lung transplantation

    Concentration and composition of proteins and other biomarkers will be analysed in lung tissue. Both taken from the native lung and from the donor lung.

  25. Concentration of proteins and other biomarkers in lung tissue

    Time frame: 1 months after lung transplantation

    Concentration and composition of proteins and other biomarkers will be analysed in lung tissue

  26. Concentration of proteins and other biomarkers in lung tissue

    Time frame: 3 months after lung transplantation

    Concentration and composition of proteins and other biomarkers will be analysed in lung tissue

  27. Concentration of proteins and other biomarkers in lung tissue

    Time frame: 6 months after lung transplantation

    Concentration and composition of proteins and other biomarkers will be analysed in lung tissue

  28. Concentration of proteins and other biomarkers in lung tissue

    Time frame: 9 months after lung transplantation

    Concentration and composition of proteins and other biomarkers will be analysed in lung tissue

  29. Concentration of proteins and other biomarkers in lung tissue

    Time frame: 12 months after lung transplantation

    Concentration and composition of proteins and other biomarkers will be analysed in lung tissue

  30. Concentration of proteins and other biomarkers in lung tissue

    Time frame: 18 months after lung transplantation

    Concentration and composition of proteins and other biomarkers will be analysed in lung tissue

  31. Concentration of proteins and other biomarkers in lung tissue

    Time frame: 2 years after lung transplantation

    Concentration and composition of proteins and other biomarkers will be analysed in lung tissue

  32. Concentration of proteins and other biomarkers in lung tissue

    Time frame: 3 years after lung transplantation

    Concentration and composition of proteins and other biomarkers will be analysed in lung tissue

  33. Concentration of proteins and other biomarkers in lung tissue

    Time frame: 4 years after lung transplantation

    Concentration and composition of proteins and other biomarkers will be analysed in lung tissue

Study contacts

Contact information is provided by the study sponsor or research team.

Sandra Lindstedt, MD, PhD

CONTACT

[email protected]

+46737220580

Sponsors and collaborators

Lead sponsor

Lund University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2024
Study completion
2026
First posted
May 16, 2022
Registry last updated
May 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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