Platelets in Cystic Fibrosis Lung Inflammation

Completed

• Conditions: Platelet Levels and Mean Platelet Volume in Patients With CF
• Interventions: Other: platelet count and mean platelet volume are obtained from whole blood count

• Registration Number: NCT05339724
• Lead Sponsor: Mersin Training and Research Hospital

Brief Summary

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

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 Timeline

• Study Start: 2022-04-08
• Study First Submitted: 2022-04-08
• Study First Submitted QC: 2022-04-15
• Study First Posted: 2022-04-21
• Primary Completion: 2022-04-30
• Status Verified: 2022-05
• Study Completion: 2022-05-01
• Last Update Submitted: 2022-05-15
• Last Update Posted: 2022-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 53

Inclusion Criteria

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

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 2. Total cystic fibrosis patients with no pulmonary exacerbation	platelet count and mean platelet volume are obtained from whole blood count	PC and MPV during no pulmonary exacerbation
Group 5. Cystic fibrosis patients with chronic colonization without pulmonary exacerbation	platelet count and mean platelet volume are obtained from whole blood count	PC and MPV during chronic colonization without pulmonary exacerbation
Group 1. Total cystic fibrosis patients with pulmonary exacerbation	platelet count and mean platelet volume are obtained from whole blood count	Platelet count (PC) and mean platelet volume (MPV) during pulmonary exacerbation.
Group 3. Cystic fibrosis patients with chronic colonization in acute pulmonary exacerbation	platelet count and mean platelet volume are obtained from whole blood count	PC and MPV during chronic colonization in acute pulmonary exacerbation
Group 6. Cystic fibrosis patients with no chronic colonization without pulmonary exacerbation	platelet count and mean platelet volume are obtained from whole blood count	PC and MPV during no chronic colonization without pulmonary exacerbation
Group 4. Cystic fibrosis patients with chronic colonization without pulmonary exacerbation	platelet count and mean platelet volume are obtained from whole blood count	PC and MPV during chronic colonization without pulmonary exacerbation

Primary Outcome Measures

Name	Time	Method
Platelet levels and mean platelet volume in acute pulmonary infection in patients with cystic fibrosis	2 weeks	Elevated platelet level count (x103/uL) and increased mean platelet volume (fl) during acute pulmonary exacerbation in cystic fibrosis patients

Trial Locations

Locations (1)

Mersin City Research & Training Hospital; 🇹🇷 Mersin, Turkey