Platelets in Cystic Fibrosis Lung Inflammation

Platelets: A Neglected Cell in Cystic Fibrosis Lung Inflammation

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.

Study Overview

• Status: Completed
• Conditions: Platelet Levels and Mean Platelet Volume in Patients With CF
• Intervention / Treatment: Other: platelet count and mean platelet volume are obtained from whole blood count

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: Observational
• Enrollment (Actual): 53

Contacts and Locations

Study Locations

• Turkey
  • Mersin, Turkey
    • Mersin City Research & Training Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 14 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Cystic fibrosis patients

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

Number of groups / cohorts

6

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.	Other: 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.
Group 2. Total cystic fibrosis patients with no pulmonary exacerbation; PC and MPV during no pulmonary exacerbation	Other: 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.
Group 3. Cystic fibrosis patients with chronic colonization in acute pulmonary exacerbation; PC and MPV during chronic colonization in acute pulmonary exacerbation	Other: 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.
Group 4. Cystic fibrosis patients with chronic colonization without pulmonary exacerbation; PC and MPV during chronic colonization without pulmonary exacerbation	Other: 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.
Group 5. Cystic fibrosis patients with chronic colonization without pulmonary exacerbation; PC and MPV during chronic colonization without pulmonary exacerbation	Other: 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.
Group 6. Cystic fibrosis patients with no chronic colonization without pulmonary exacerbation; PC and MPV during no chronic colonization without pulmonary exacerbation	Other: 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.

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	Elevated platelet level count (x103/uL) and increased mean platelet volume (fl) during acute pulmonary exacerbation in cystic fibrosis patients	2 weeks

Collaborators and Investigators

• Sponsor: Mersin Training and Research Hospital
• 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): April 8, 2022
• Primary Completion (Actual): April 30, 2022
• Study Completion (Actual): May 1, 2022

Study Registration Dates

• First Submitted: April 8, 2022
• First Submitted That Met QC Criteria: April 15, 2022
• First Posted (Actual): April 21, 2022

Study Record Updates

• Last Update Posted (Actual): May 20, 2022
• Last Update Submitted That Met QC Criteria: May 15, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: cystic fibrosis, platelet count, mean platelet volume
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Infant, Newborn, Diseases; Genetic Diseases, Inborn; Pancreatic Diseases; Fibrosis; Inflammation; Pneumonia; Pulmonary Fibrosis; Cystic Fibrosis
• Other Study ID Numbers: 2022/138

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No