Platelets in Cystic Fibrosis Lung Inflammation

NCT ID: NCT05339724

Last Updated: 2022-05-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

53 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-04-08

Study Completion Date

2022-05-01

Brief Summary

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Cystic fibrosis (CF) is a chronic multiorgan disorder caused by mutations in the CFTR (cystic fibrosis transmembrane conductance regulator) gene. Chronic airway infection by bacterial pathogens accounts for the progressive, suppurative pulmonary disease that leads to significant morbidity and mortality in patients with CF. Neutrophil recruitment to the lungs accounts the most important contributor to pulmonary destruction. However, there is evidence that platelets may also have an important role in the pathogenesis of inflammation. To our knowledge, there is few information in platelet levels in patients with cystic fibrosis during pulmonary exacerbation, chronic airway colonization and when stable.

Detailed Description

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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.

Conditions

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Platelet Levels and Mean Platelet Volume in Patients With CF

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Study Groups

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Group 1. Total cystic fibrosis patients with pulmonary exacerbation

Platelet count (PC) and mean platelet volume (MPV) during pulmonary exacerbation.

platelet count and mean platelet volume are obtained from whole blood count

Intervention Type OTHER

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

platelet count and mean platelet volume are obtained from whole blood count

Intervention Type OTHER

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

platelet count and mean platelet volume are obtained from whole blood count

Intervention Type OTHER

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

platelet count and mean platelet volume are obtained from whole blood count

Intervention Type OTHER

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

platelet count and mean platelet volume are obtained from whole blood count

Intervention Type OTHER

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

platelet count and mean platelet volume are obtained from whole blood count

Intervention Type OTHER

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.

Interventions

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platelet count and mean platelet volume are obtained from whole blood count

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* All regularly followed cystic fibrosis patients with clinical and laboratory results could be obtained from medical charts.

Exclusion Criteria

* None
Minimum Eligible Age

12 Months

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mersin Training and Research Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Ali Özdemir

Assoc Prof

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ali Özdemir, MD

Role: PRINCIPAL_INVESTIGATOR

Assoc Prof, Mersin City Research & Training Hospital

Murat Ersoy, MD

Role: STUDY_CHAIR

Clinical Pediatrician, Mersin City Research & Training Hospital

Locations

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Mersin City Research & Training Hospital

Mersin, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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2022/138

Identifier Type: -

Identifier Source: org_study_id

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