Platelets in Cystic Fibrosis Lung Inflammation

• Sponsor: Mersin Training and Research Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT05339724
• Collaborator: (none)
• Enrollment: 53
• Location: 1
• Actual Duration (Days): 23
• Patients Per Site Per Month: 70.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Platelet Levels and Mean Platelet Volume in Patients With CF	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 Design

• Study Type: Observational
• Actual Enrollment: 53 participants
• Observational Model: Other
• Time Perspective: Retrospective
• Official Title: Platelets: A Neglected Cell in Cystic Fibrosis Lung Inflammation
• Actual Study Start Date: Apr 8, 2022
• Actual Primary Completion Date: Apr 30, 2022
• Actual Study Completion Date: May 1, 2022

Arms and Interventions

Arm	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.

Outcome Measures

Primary Outcome Measures

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Months to 18 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

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

Exclusion Criteria:

• None

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mersin City Research & Training Hospital	Mersin		Turkey

Sponsors and Collaborators

• 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ali Özdemir, Assoc Prof, Mersin Training and Research Hospital
• ClinicalTrials.gov Identifier: NCT05339724
• Other Study ID Numbers: 2022/138
• First Posted: Apr 21, 2022
• Last Update Posted: May 20, 2022
• Last Verified: May 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Ali Özdemir, Assoc Prof, Mersin Training and Research Hospital: cystic fibrosis, platelet count, mean platelet volume
• Additional relevant MeSH terms: Pneumonia; Cystic Fibrosis; Pulmonary Fibrosis; Fibrosis; Inflammation

Study Results

No Results Posted as of May 20, 2022