- ICH GCP
- USA klinikai vizsgálatok nyilvántartása
- Klinikai vizsgálat NCT07693127
Red Blood Cell and Platelet Indices for Predicting Outcomes in Acute Exacerbations of COPD
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.
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.
A tanulmány áttekintése
Állapot
Részletes leírás
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.
Tanulmány típusa
Beiratkozás (Becsült)
Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
- Felnőtt
- Idősebb felnőtt
Egészséges önkénteseket fogad
Mintavételi módszer
Tanulmányi populáció
Leírás
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).
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
Kohorszok és beavatkozások
Csoport / Kohorsz |
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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.
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Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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Dyspnea Severity Score
Időkeret: Baseline
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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.
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Baseline
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Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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Length of Hospital Stay
Időkeret: From the date of hospital admission until the date of hospital discharge, assessed up to 30 days.
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The total number of days the patient remains hospitalized for the treatment of the acute exacerbation of COPD.
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From the date of hospital admission until the date of hospital discharge, assessed up to 30 days.
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Együttműködők és nyomozók
Szponzor
Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete (Becsült)
Elsődleges befejezés (Becsült)
A tanulmány befejezése (Becsült)
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Tényleges)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
Kulcsszavak
További vonatkozó MeSH feltételek
Egyéb vizsgálati azonosító számok
- RBC & Platelet Indices in COPD
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