Red Blood Cell and Platelet Indices for Predicting Outcomes in Acute Exacerbations of COPD
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Acute Exacerbation of Chronic Obstructive Pulmonary Disease, Chronic Obstructive Pulmonary Disease (COPD), AECOPD. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Assessment of Red Blood Cell and Platelet Indices in Predicting Outcome in Patients With Acute Exacerbation of Chronic Obstructive Pulmonary Disease
Overview
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.
Primary outcome measures
- Dyspnea Severity Score [Time frame: Baseline]
Secondary outcome measures (1)
- Length of Hospital Stay [Time frame: From the date of hospital admission until the date of hospital discharge, assessed up to 30 days.]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07693127 · RBC & Platelet Indices in COPD