Platelets in Cystic Fibrosis Lung Inflammation

NCT05339724 | Completed

• 1 other identifier: 2022/138
• Study Type: observational
• Target: 53
• Locations: 1 country
• Sites: 1

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.

Conditions

Platelet Levels and Mean Platelet Volume in Patients With CF

Keywords

cystic fibrosis, platelet count, mean platelet volume

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (6)

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

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

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

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

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

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

Interventions

platelet count and mean platelet volume are obtained from whole blood count 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 1. Total cystic fibrosis patients with pulmonary exacerbation; Group 2. Total cystic fibrosis patients with no pulmonary exacerbation; Group 3. Cystic fibrosis patients with chronic colonization in acute pulmonary exacerbation; Group 4. Cystic fibrosis patients with chronic colonization without pulmonary exacerbation; Group 5. Cystic fibrosis patients with chronic colonization without pulmonary exacerbation; Group 6. Cystic fibrosis patients with no chronic colonization without pulmonary exacerbation

Eligibility Criteria

• Age: 12 Months - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Cystic fibrosis patients

You may qualify if:

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

You may not qualify if:

• None

Sponsors & Collaborators

• Mersin Training and Research Hospital: lead

Study Sites (1)

Mersin City Research & Training Hospital

Mersin, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

Platelet Count

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Intervention Hierarchy (Ancestors)

Blood Cell Count; Cell Count; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Hematologic Tests; Platelet Function Tests; Investigative Techniques; Cell Physiological Phenomena; Blood Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Officials

• Ali Özdemir, MD

  Assoc Prof, Mersin City Research & Training Hospital

  PRINCIPAL INVESTIGATOR

• Murat Ersoy, MD

  Clinical Pediatrician, Mersin City Research & Training Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc Prof

Study Record Dates

• First Submitted: April 8, 2022
• First Posted: April 21, 2022
• Study Start: April 8, 2022
• Primary Completion: April 30, 2022
• Study Completion: May 1, 2022
• Last Updated: May 20, 2022

Record last verified: 2022-05

Locations

TU (1)