Actively Recruiting

Age: 16Years - 75Years
All Genders
ID05375149

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

Led by Lund University Hospital · Updated on 2022-05-16

150

Participants Needed

1

Research Sites

104 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Lung transplantation is currently the only effective treatment for people with end-stage lung disease, but survival rates remain low with a mean of five years. A major challenge after lung transplantation is primary graft dysfunction, which causes early death and contributes to chronic lung allograft dysfunction, the leading cause of late mortality. Detecting rejection earlier could improve treatment options and survival chances. Researchers have found that particles in exhaled breath can reflect lung lining fluid and may help monitor lung diseases and transplant rejection. This study collects samples of exhaled breath particles and measures the particle flow rate in lung transplant patients at Skåne University Hospital in Lund. Samples are taken repeatedly after transplantation while patients are in the hospital and at follow-up visits at 3, 6, and 12 months post-transplant and yearly thereafter. Blood samples are collected before the transplant and during follow-up, and additional lung fluid and tissue samples are taken during routine bronchoscopies. The study compares patients with and without lung transplant rejection to identify early signs and potential biomarkers. Participants will undergo regular measurements of exhaled breath particles and particle flow rates using a specialized system. Blood and lung fluid samples will be analyzed for proteins and other markers at various time points before and up to four years after transplantation. Researchers will monitor these markers over time to detect early rejection. The study aims to improve diagnosis and treatment of lung transplant rejection by finding new, non-invasive indicators. Participation may last several years with ongoing follow-up assessments and sample collections.

CONDITIONS

Brief Title

Exhaled Breath Particles in Lung Transplantation

Who Can Participate

Age: 16Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients who have undergone lung transplantation at Skåne University Hospital, SUS Lund
Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 screening and enrollment visit

Diagnostic Evaluation

Duration - Pre-transplantation and day of transplantation

Samples of exhaled breath particles and blood are collected before and at the time of lung transplantation to assess baseline biomarkers.

1 preoperative visit and 1 visit at transplantation

Monitoring

Duration - Up to 4 years post-transplantation

Participants are observed with repeated measurements of exhaled breath particles, blood samples, bronchoalveolar lavage fluid, and lung biopsies during hospital stay and routine follow-up visits to detect signs of acute or chronic lung rejection.

Repeated visits during hospital stay, plus visits at 1, 3, 6, 9, 12, 18 months and annually up to 4 years

Trial Site Locations

Total: 1 location

1

Skåne University Hospital

Lund, Skåne County, Sweden, 224 60

Actively Recruiting

Loading map...

Research Team

S

Sandra Lindstedt, MD, PhD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

Similar Trials

The Use of Extracorporeal Photopheresis as Immunomodulatory ...

Antibody-mediated Rejection

Actively Recruiting

7 locations

A Randomized, Double-blind, Placebo-controlled Study to Eval...

Lung Transplant Rejection

Actively Recruiting

80 locations

A Prospective, Randomized Clinical Trial to Evaluate the Fea...

Lung Transplant Rejection

Actively Recruiting

1 location

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Published Research Related To This Trial

Increased particle flow rate from airways precedes clinical signs of ARDS in a porcine model of LPS-induced acute lung injury.

Martin Stenlo, Snejana Hyllén, Iran A N Silva...

https://pubmed.ncbi.nlm.nih.gov/31994907

Particle Flow Profiles From the Airways Measured by PExA Differ in Lung Transplant Recipients Who Develop Primary Graft Dysfunction.

Ellen Broberg, Snejana Hyllén, Lars Algotsson...

https://pubmed.ncbi.nlm.nih.gov/31615381

Surfactant Protein A in particles in exhaled air (PExA), bronchial lavage and bronchial wash - a methodological comparison.

Annelie F Behndig, Ekaterina Mirgorodskaya, Anders Blomberg...

https://pubmed.ncbi.nlm.nih.gov/31558154