Viewing Study NCT05375149



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Last Modification Date: 2024-10-26 @ 2:32 PM
Study NCT ID: NCT05375149
Status: RECRUITING
Last Update Posted: 2022-05-16
First Post: 2022-05-10

Brief Title: Exhaled Breath Particles in Lung Transplantation
Sponsor: Lund University Hospital
Organization: Lund University Hospital

Study Overview

Official Title: Exhaled Breath Particles as a Clinical Indicator for Acute and Chronic Rejection After Lung Transplantation
Status: RECRUITING
Status Verified Date: 2022-02
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None