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临床试验/NCT07693127
NCT07693127尚未招募不适用

Assessment of Red Blood Cell and Platelet Indices in Predicting Outcome in Patients With Acute Exacerbation of Chronic Obstructive Pulmonary Disease

Assiut University0 个研究点目标入组 50 人开始时间: 2026年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
50
主要终点
Dyspnea Severity Score

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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).

结局指标

主要结局

Dyspnea Severity Score

时间窗: 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.

次要结局

  • Length of Hospital Stay(From the date of hospital admission until the date of hospital discharge, assessed up to 30 days.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Maha Elsayed Allam

Resident at Chest Diseases Department

Assiut University

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