Low Levels of Exhaled Surfactant Protein A Associated With BOS After Lung Transplantation.
Petrea A Ericson, Ekaterina Mirgorodskaya, Oscar S Hammar...
https://pubmed.ncbi.nlm.nih.gov/27795995Actively Recruiting
Led by Lund University Hospital · Updated on 2022-05-16
150
Participants Needed
1
Research Sites
104 weeks
Total Duration
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
Exhaled Breath Particles in Lung Transplantation
You may qualify if you...
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
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
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
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
Total: 1 location
1
Skåne University Hospital
Lund, Skåne County, Sweden, 224 60
Actively Recruiting
S
Sandra Lindstedt, MD, PhD
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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Petrea A Ericson, Ekaterina Mirgorodskaya, Oscar S Hammar...
https://pubmed.ncbi.nlm.nih.gov/27795995Martin Stenlo, Snejana Hyllén, Iran A N Silva...
https://pubmed.ncbi.nlm.nih.gov/31994907Ellen Broberg, Snejana Hyllén, Lars Algotsson...
https://pubmed.ncbi.nlm.nih.gov/31615381Annelie F Behndig, Ekaterina Mirgorodskaya, Anders Blomberg...
https://pubmed.ncbi.nlm.nih.gov/31558154