Acute Exacerbation of Chronic Obstructive Pulmonary DiseaseNCT07693127
Red Blood Cell and Platelet Indices for Predicting Outcomes in Acute Exacerbations of COPD
An observational study of Acute Exacerbation of Chronic Obstructive Pulmonary Disease and Chronic Obstructive Pulmonary Disease (COPD), run by Assiut University.
Trial summary
The purpose of this study is to evaluate if standard, easily accessible blood tests can help doctors predict the severity and outcomes of sudden flare-ups in patients with Chronic Obstructive Pulmonary Disease (COPD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Exacerbation of Chronic Obstructive Pulmonary Disease, Chronic Obstructive Pulmonary Disease (COPD), AECOPD
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Aug 2026to Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- Adult, Older adult
Study population: The study population consists of adult patients (over 18 years of age) diagnosed with Chronic Obstructive Pulmonary Disease (COPD) who are admitted to the Chest Diseases and Tuberculosis Department at Assiut University Hospital due to an acute exacerbation of their condition (AECOPD).
Who may be able to join
- Patients above 18 years admitted to the department with AECOPD defined as an event characterized by increased dyspnea and/or cough and sputum that worsens in ≤14 days.
Who cannot join
- Primary reason for admission other than AECOPD.
- The patient has a diagnosis of connective tissue disorder, inflammatory bowel disease, or hematological system diseases (such as malignancy, thalassemia, hemolytic anemia).
About this study
Official title: Assessment of Red Blood Cell and Platelet Indices in Predicting Outcome in Patients With Acute Exacerbation of Chronic Obstructive Pulmonary Disease
The purpose of this study is to evaluate if standard, easily accessible blood tests can help doctors predict the severity and outcomes of sudden flare-ups in patients with Chronic Obstructive Pulmonary Disease (COPD).
When a patient's COPD suddenly worsens, an event called an acute exacerbation, it can lead to serious health complications, breathing difficulties, and hospitalization. Currently, doctors need simple and cost-effective ways to figure out early on which patients are at the highest risk for severe complications.
Read more
This observational study will focus on specific components of a routine Complete Blood Count (CBC) test. Researchers will look at the size, volume, and variation of red blood cells (such as Red Cell Distribution Width, or RDW) and platelets. Both red blood cells and platelets are known to be affected by the body's systemic inflammatory response during a severe COPD flare-up.
Participants will include adults over 18 years old who are admitted to the hospital for an acute exacerbation of COPD. As part of the study, researchers will collect and analyze routine clinical data, including:
- Medical history and physical examination findings (including dyspnea severity).
- Standard laboratory blood tests (evaluating red blood cells, platelets, kidney and liver function, and inflammation markers).
- Arterial blood gas levels.
- Pulmonary function tests (breathing tests to measure lung capacity).
- High-resolution computed tomography (HRCT) chest scans.
By analyzing this information, the study aims to determine if red blood cell and platelet indices can accurately predict important clinical outcomes. These outcomes include the need for Intensive Care Unit (ICU) admission, the need for a mechanical ventilator (breathing machine), the total length of the hospital stay, and in-hospital mortality. Identifying reliable biomarkers could help healthcare providers make faster, more targeted treatment decisions for COPD patients.
Read the detailed description
Chronic Obstructive Pulmonary Disease (COPD) is a progressive respiratory disorder characterized by persistent airflow limitation and a heightened inflammatory response in the airways. While traditionally viewed strictly as a pulmonary condition, COPD is now widely understood to encompass systemic inflammation, oxidative stress, and immune dysregulation. The clinical trajectory of COPD is frequently punctuated by acute exacerbations (AECOPD), defined as a sudden and severe worsening of respiratory symptoms. These exacerbations accelerate lung function decline, increase the risk of acute respiratory failure (ARF), and are associated with recurrent hospitalizations and high mortality rates.
During an AECOPD, patients experience high-grade systemic inflammation, which is typically reflected by elevated conventional markers such as C-reactive protein (CRP). However, there is a pressing clinical need for more accessible, rapid, and cost-effective biomarkers to aid in early risk stratification upon hospital admission.
Routine hematological analysis, specifically the complete blood count (CBC), offers several promising, non-invasive prognostic markers.
Red Cell Distribution Width (RDW) is a quantitative measure of anisocytosis (variability in red blood cell size). Evidence indicates that elevated RDW is not just a marker of anemia, but reflects underlying chronic inflammation, oxidative stress, and impaired erythropoiesis. In COPD, elevated RDW has been correlated with disease severity, hypercapnia, prolonged hospital stays, and increased risk of in-hospital and ICU mortality.
Furthermore, platelets are critical mediators in inflammatory processes and endothelial dysfunction. Platelet activation plays a role in the pathophysiology of COPD exacerbations. Inflammatory cytokines can interfere with megakaryopoiesis, altering platelet production and activation dynamics. Consequently, indices such as Mean Platelet Volume (MPV), Platelet Distribution Width (PDW), Plateletcrit (PCT%), and the Platelet Large Cell Ratio (P-LCR) undergo significant changes during an acute exacerbation.
Despite this evidence, the combined clinical utility of RDW and specific platelet indices in predicting distinct severity grades and clinical outcomes in real-world AECOPD management remains incompletely defined.
This prospective cohort study aims to evaluate the combined prognostic utility of these basic hematological indices. Patients admitted to the Chest Diseases and Tuberculosis Department with a primary diagnosis of AECOPD will be evaluated.
Upon enrollment, all participants will undergo a comprehensive clinical assessment, including a detailed medical history and physical examination. Dyspnea severity will be clinically graded.
The diagnostic and assessment workflow includes:
- Laboratory Investigations: A comprehensive metabolic and hematological panel will be drawn, focusing heavily on RBC indices (MCV, MCH, MCHC, RDW, Hct), Platelet Indices (PDW, PCT, MPV), and inflammatory ratios (Lymphocyte-to-Monocyte and Lymphocyte-to-Neutrophil ratios). Additional tests include kidney and liver function tests, coagulation profiles, ESR, and CRP.
- Arterial Blood Gases (ABG): To assess respiratory failure status and gas exchange parameters (PaO2, PaCO2, SaO2, HCO3).
- Pulmonary Function Tests (PFTs): To quantify airflow limitation (FEV1, FVC, and FEV1/FVC ratio) in accordance with the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines, as patient condition permits.
- Radiological Assessment: High-Resolution Computed Tomography (HRCT) of the chest will be utilized as a non-invasive tool to characterize anatomical changes and identify further COPD phenotypes or complications.
- Conditions
- Acute Exacerbation of Chronic Obstructive Pulmonary Disease, Chronic Obstructive Pulmonary Disease (COPD), AECOPD
- Keywords
- Red Blood Cell Indices, Platelet Indices, Red Cell Distribution Width (RDW), Mean Platelet Volume (MPV), Platelet Distribution Width (PDW), Biomarkers, Prognosis, Systemic Inflammation
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| AECOPD Patients | Adult patients (over 18 years of age) admitted to the Chest Diseases and Tuberculosis department with an Acute Exacerbation of Chronic Obstructive Pulmonary Disease (AECOPD). Participants will undergo routine clinical and laboratory assessments, including complete blood counts to evaluate red blood cell and platelet indices, arterial blood gases, pulmonary function tests (PFTs), and high-resolution computed tomography (HRCT) to predict disease severity and clinical outcomes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dyspnea Severity Score
Dyspnea severity will be quantified using the modified Medical Research Council (mMRC) dyspnea scale. This scale evaluates the degree of breathlessness on a grading system from 0 to 4, with higher grades indicating more severe symptoms.
Measured: Baseline
Secondary outcomes (1)
Length of Hospital Stay
The total number of days the patient remains hospitalized for the treatment of the acute exacerbation of COPD.
Measured: From the date of hospital admission until the date of hospital discharge, assessed up to 30 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2026
- Study startAug 2026 (estimated)
- Primary completionAug 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Exacerbation of Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maha Elsayed Allam, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07693127
- Sponsor's protocol ID
- RBC & Platelet Indices in COPD
- Status last verified
- Jul 2026
- First submitted
- 28 Jun 2026
- Last updated
- 9 Jul 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Red Blood Cell and Platelet Indices in Predicting Outcome in Patients With Acute Exacerbation of Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT07693127
- Acronym / sponsor ID
- RBC & Platelet Indices in COPD
- Conditions
- Acute Exacerbation of Chronic Obstructive Pulmonary Disease, Chronic Obstructive Pulmonary Disease (COPD), AECOPD
- Keywords
- Red Blood Cell Indices, Platelet Indices, Red Cell Distribution Width (RDW), Mean Platelet Volume (MPV), Platelet Distribution Width (PDW), Biomarkers, Prognosis, Systemic Inflammation
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Aug 2026 (estimated)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 9 Jul 2026 (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.
The purpose of this study is to evaluate if standard, easily accessible blood tests can help doctors predict the severity and outcomes of sudden flare-ups in patients with Chronic Obstructive Pulmonary Disease (COPD).
When a patient's COPD suddenly worsens, an event called an acute exacerbation, it can lead to serious health complications, breathing difficulties, and hospitalization. Currently, doctors need simple and cost-effective ways to figure out early on which patients are at the highest risk for severe complications.
This observational study will focus on specific components of a routine Complete Blood Count (CBC) test. Researchers will look at the size, volume, and variation of red blood cells (such as Red Cell Distribution Width, or RDW) and platelets. Both red blood cells and platelets are known to be affected by the body's systemic inflammatory response during a severe COPD flare-up.
Participants will include adults over 18 years old who are admitted to the hospital for an acute exacerbation of COPD. As part of the study, researchers will collect and analyze routine clinical data, including:
- Medical history and physical examination findings (including dyspnea severity).
- Standard laboratory blood tests (evaluating red blood cells, platelets, kidney and liver function, and inflammation markers).
- Arterial blood gas levels.
- Pulmonary function tests (breathing tests to measure lung capacity).
- High-resolution computed tomography (HRCT) chest scans.
By analyzing this information, the study aims to determine if red blood cell and platelet indices can accurately predict important clinical outcomes. These outcomes include the need for Intensive Care Unit (ICU) admission, the need for a mechanical ventilator (breathing machine), the total length of the hospital stay, and in-hospital mortality. Identifying reliable biomarkers could help healthcare providers make faster, more targeted treatment decisions for COPD patients.
Detailed description
Chronic Obstructive Pulmonary Disease (COPD) is a progressive respiratory disorder characterized by persistent airflow limitation and a heightened inflammatory response in the airways. While traditionally viewed strictly as a pulmonary condition, COPD is now widely understood to encompass systemic inflammation, oxidative stress, and immune dysregulation. The clinical trajectory of COPD is frequently punctuated by acute exacerbations (AECOPD), defined as a sudden and severe worsening of respiratory symptoms. These exacerbations accelerate lung function decline, increase the risk of acute respiratory failure (ARF), and are associated with recurrent hospitalizations and high mortality rates.
During an AECOPD, patients experience high-grade systemic inflammation, which is typically reflected by elevated conventional markers such as C-reactive protein (CRP). However, there is a pressing clinical need for more accessible, rapid, and cost-effective biomarkers to aid in early risk stratification upon hospital admission.
Routine hematological analysis, specifically the complete blood count (CBC), offers several promising, non-invasive prognostic markers.
Red Cell Distribution Width (RDW) is a quantitative measure of anisocytosis (variability in red blood cell size). Evidence indicates that elevated RDW is not just a marker of anemia, but reflects underlying chronic inflammation, oxidative stress, and impaired erythropoiesis. In COPD, elevated RDW has been correlated with disease severity, hypercapnia, prolonged hospital stays, and increased risk of in-hospital and ICU mortality.
Furthermore, platelets are critical mediators in inflammatory processes and endothelial dysfunction. Platelet activation plays a role in the pathophysiology of COPD exacerbations. Inflammatory cytokines can interfere with megakaryopoiesis, altering platelet production and activation dynamics. Consequently, indices such as Mean Platelet Volume (MPV), Platelet Distribution Width (PDW), Plateletcrit (PCT%), and the Platelet Large Cell Ratio (P-LCR) undergo significant changes during an acute exacerbation.
Despite this evidence, the combined clinical utility of RDW and specific platelet indices in predicting distinct severity grades and clinical outcomes in real-world AECOPD management remains incompletely defined.
This prospective cohort study aims to evaluate the combined prognostic utility of these basic hematological indices. Patients admitted to the Chest Diseases and Tuberculosis Department with a primary diagnosis of AECOPD will be evaluated.
Upon enrollment, all participants will undergo a comprehensive clinical assessment, including a detailed medical history and physical examination. Dyspnea severity will be clinically graded.
The diagnostic and assessment workflow includes:
- Laboratory Investigations: A comprehensive metabolic and hematological panel will be drawn, focusing heavily on RBC indices (MCV, MCH, MCHC, RDW, Hct), Platelet Indices (PDW, PCT, MPV), and inflammatory ratios (Lymphocyte-to-Monocyte and Lymphocyte-to-Neutrophil ratios). Additional tests include kidney and liver function tests, coagulation profiles, ESR, and CRP.
- Arterial Blood Gases (ABG): To assess respiratory failure status and gas exchange parameters (PaO2, PaCO2, SaO2, HCO3).
- Pulmonary Function Tests (PFTs): To quantify airflow limitation (FEV1, FVC, and FEV1/FVC ratio) in accordance with the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines, as patient condition permits.
- Radiological Assessment: High-Resolution Computed Tomography (HRCT) of the chest will be utilized as a non-invasive tool to characterize anatomical changes and identify further COPD phenotypes or complications.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AECOPD Patients | – | –Adult patients (over 18 years of age) admitted to the Chest Diseases and Tuberculosis department with an Acute Exacerbation of Chronic Obstructive Pulmonary Disease (AECOPD). Participants will undergo routine clinical and laboratory assessments, including complete blood counts to evaluate red blood cell and platelet indices, arterial blood gases, pulmonary function tests (PFTs), and high-resolution computed tomography (HRCT) to predict disease severity and clinical outcomes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The study population consists of adult patients (over 18 years of age) diagnosed with Chronic Obstructive Pulmonary Disease (COPD) who are admitted to the Chest Diseases and Tuberculosis Department at Assiut University Hospital due to an acute exacerbation of their condition (AECOPD).
Key inclusion criteria (1 listed)
- Patients above 18 years admitted to the department with AECOPD defined as an event characterized by increased dyspnea and/or cough and sputum that worsens in ≤14 days.
Key exclusion criteria (2 listed)
- Primary reason for admission other than AECOPD.
- The patient has a diagnosis of connective tissue disorder, inflammatory bowel disease, or hematological system diseases (such as malignancy, thalassemia, hemolytic anemia).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Dyspnea Severity Score
Time frame: Baseline
Dyspnea severity will be quantified using the modified Medical Research Council (mMRC) dyspnea scale. This scale evaluates the degree of breathlessness on a grading system from 0 to 4, with higher grades indicating more severe symptoms.
1 secondary outcome
Length of Hospital Stay
Time frame: From the date of hospital admission until the date of hospital discharge, assessed up to 30 days.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Exacerbation of Chronic Obstructive Pulmonary Disease and Chronic Obstructive Pulmonary Disease (COPD), run by Assiut University.
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 2 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: opening soon, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
Dyspnea Severity Score (time frame: Baseline). 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 9 Jul 2026.