- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05339724
Platelets in Cystic Fibrosis Lung Inflammation
Platelets: A Neglected Cell in Cystic Fibrosis Lung Inflammation
Study Overview
Status
Intervention / Treatment
Detailed Description
Airway inflammation in CF is predominantly neutrophilic in nature with increased concentrations of pro-inflammatory mediators include TNF-α, IL-1β, IL-6, IL-8, IL-17, IL-33, GM-CSF and G-CSF. In addition, other cell types including macrophages and T-lymphocytes are expressed by CFTR and contribute to the CF inflammatory response.
Researches have indicated that platelets may also have a significant contribution to the inflammation. Platelet depletion or antiplatelet therapies attenuate injury and mortality in animal models of acute lung injury. More importantly, CFTR expression has been shown on human platelets. Recent data suggests that CF patients have an increase in circulating activated platelets and platelet reactivity.
Taken together, these observations support a potentially important role of platelets in regulating lung inflammation in CF. However, there are few studies examine platelet and lung inflammation interraction in patients with CF. Therefore we aimed to investigate platelet count (PC) and mean platelet volume (MPV) levels in various conditions in our CF patients.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Mersin, Turkey
- Mersin City Research & Training Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- All regularly followed cystic fibrosis patients with clinical and laboratory results could be obtained from medical charts.
Exclusion Criteria:
- None
Study Plan
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Group 1. Total cystic fibrosis patients with pulmonary exacerbation
Platelet count (PC) and mean platelet volume (MPV) during pulmonary exacerbation.
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The records of cystic fibrosis patients will be retrospectively evaluated for acute pulmonary exacerbation, chronic airway colonization for bacteria, clinical stable status.
PC and MPV will be obtained and matched in 6 groups (described above).
Then, PC and MPV will be compared among the groups.
|
Group 2. Total cystic fibrosis patients with no pulmonary exacerbation
PC and MPV during no pulmonary exacerbation
|
The records of cystic fibrosis patients will be retrospectively evaluated for acute pulmonary exacerbation, chronic airway colonization for bacteria, clinical stable status.
PC and MPV will be obtained and matched in 6 groups (described above).
Then, PC and MPV will be compared among the groups.
|
Group 3. Cystic fibrosis patients with chronic colonization in acute pulmonary exacerbation
PC and MPV during chronic colonization in acute pulmonary exacerbation
|
The records of cystic fibrosis patients will be retrospectively evaluated for acute pulmonary exacerbation, chronic airway colonization for bacteria, clinical stable status.
PC and MPV will be obtained and matched in 6 groups (described above).
Then, PC and MPV will be compared among the groups.
|
Group 4. Cystic fibrosis patients with chronic colonization without pulmonary exacerbation
PC and MPV during chronic colonization without pulmonary exacerbation
|
The records of cystic fibrosis patients will be retrospectively evaluated for acute pulmonary exacerbation, chronic airway colonization for bacteria, clinical stable status.
PC and MPV will be obtained and matched in 6 groups (described above).
Then, PC and MPV will be compared among the groups.
|
Group 5. Cystic fibrosis patients with chronic colonization without pulmonary exacerbation
PC and MPV during chronic colonization without pulmonary exacerbation
|
The records of cystic fibrosis patients will be retrospectively evaluated for acute pulmonary exacerbation, chronic airway colonization for bacteria, clinical stable status.
PC and MPV will be obtained and matched in 6 groups (described above).
Then, PC and MPV will be compared among the groups.
|
Group 6. Cystic fibrosis patients with no chronic colonization without pulmonary exacerbation
PC and MPV during no chronic colonization without pulmonary exacerbation
|
The records of cystic fibrosis patients will be retrospectively evaluated for acute pulmonary exacerbation, chronic airway colonization for bacteria, clinical stable status.
PC and MPV will be obtained and matched in 6 groups (described above).
Then, PC and MPV will be compared among the groups.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Platelet levels and mean platelet volume in acute pulmonary infection in patients with cystic fibrosis
Time Frame: 2 weeks
|
Elevated platelet level count (x103/uL) and increased mean platelet volume (fl) during acute pulmonary exacerbation in cystic fibrosis patients
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2 weeks
|
Collaborators and Investigators
Investigators
- Principal Investigator: Ali Özdemir, MD, Assoc Prof, Mersin City Research & Training Hospital
- Study Chair: Murat Ersoy, MD, Clinical Pediatrician, Mersin City Research & Training Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2022/138
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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