Platelet Levels and Mean Platelet Volume in Patients With CFNCT05339724
Platelets in Cystic Fibrosis Lung Inflammation
An observational study of Platelet Levels and Mean Platelet Volume in Patients With CF, run by Mersin Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 12 months to 18 years
- Conditions the study is for
- Platelet Levels and Mean Platelet Volume in Patients With CF
- What is being tested?
- platelet count and mean platelet volume are obtained from whole blood count
- How many people
- 53 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 Apr 2022to 1 May 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 months to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Cystic fibrosis patients
Who may be able to join
- All regularly followed cystic fibrosis patients with clinical and laboratory results could be obtained from medical charts.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Mersin City Research & Training Hospital
Mersin
About this study
Official title: 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.
Read the 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.
- Being tested
- platelet count and mean platelet volume are obtained from whole blood count
- Keywords
- cystic fibrosis, platelet count, mean platelet volume
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
platelet count and mean platelet volume are obtained from whole blood countOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1. Total cystic fibrosis patients with pulmonary exacerbation | Platelet count (PC) and mean platelet volume (MPV) during pulmonary exacerbation. Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: Other: platelet count and mean platelet volume are obtained from whole blood count |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2022
- Study start8 Apr 2022
- Primary completion30 Apr 2022
- Study completion1 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Platelet Levels and Mean Platelet Volume in Patients With CFStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mersin Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ali Özdemir, Mersin Training and Research Hospital
- Investigators
- Ali Özdemir, MD, Principal investigator, Assoc Prof, Mersin City Research & Training HospitalMurat Ersoy, MD, Study chair, Clinical Pediatrician, Mersin City Research & Training Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05339724
- Sponsor's protocol ID
- 2022/138
- Status last verified
- May 2022
- First submitted
- 8 Apr 2022
- Last updated
- 20 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Platelets: A Neglected Cell in Cystic Fibrosis Lung Inflammation
- ClinicalTrials.gov ID
- NCT05339724
- Acronym / sponsor ID
- 2022/138
- Keywords
- cystic fibrosis, platelet count, mean platelet volume
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Mersin Training and Research HospitalOther government
- Study start
- 8 Apr 2022 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 1 May 2022 (actual)
- First posted
- 21 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Group 1. Total cystic fibrosis patients with pulmonary exacerbation | – | Other: platelet count and mean platelet volume are obtained from whole blood countPlatelet count (PC) and mean platelet volume (MPV) during pulmonary exacerbation. |
| Group 2. Total cystic fibrosis patients with no pulmonary exacerbation | – | Other: platelet count and mean platelet volume are obtained from whole blood countPC and MPV during no pulmonary exacerbation |
| Group 3. Cystic fibrosis patients with chronic colonization in acute pulmonary exacerbation | – | Other: platelet count and mean platelet volume are obtained from whole blood countPC and MPV during chronic colonization in acute pulmonary exacerbation |
| Group 4. Cystic fibrosis patients with chronic colonization without pulmonary exacerbation | – | Other: platelet count and mean platelet volume are obtained from whole blood countPC and MPV during chronic colonization without pulmonary exacerbation |
| Group 5. Cystic fibrosis patients with chronic colonization without pulmonary exacerbation | – | Other: platelet count and mean platelet volume are obtained from whole blood countPC and MPV during chronic colonization without pulmonary exacerbation |
| Group 6. Cystic fibrosis patients with no chronic colonization without pulmonary exacerbation | – | Other: platelet count and mean platelet volume are obtained from whole blood countPC and MPV during no chronic colonization without pulmonary exacerbation |
Who may qualify
- Ages
- 12 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Cystic fibrosis patients
Key inclusion criteria (1 listed)
- All regularly followed cystic fibrosis patients with clinical and laboratory results could be obtained from medical charts.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| platelet count and mean platelet volume are obtained from whole blood countThe 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. | Other | 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 |
Primary outcome
Platelet levels and mean platelet volume in acute pulmonary infection in patients with cystic fibrosis
Time frame: 2 weeks
Elevated platelet level count (x103/uL) and increased mean platelet volume (fl) during acute pulmonary exacerbation in cystic fibrosis patients
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2022.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ali Özdemir, MD principal investigator
Assoc Prof, Mersin City Research & Training Hospital
Murat Ersoy, MD study chair
Clinical Pediatrician, Mersin City Research & Training Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Platelet Levels and Mean Platelet Volume in Patients With CF, run by Mersin Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Platelet levels and mean platelet volume in acute pulmonary infection in patients with cystic fibrosis (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2022.