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Red Blood Cell and Platelet Indices for Predicting Outcomes in Acute Exacerbations of COPD

2026年7月3日 更新者:Maha Elsayed Allam、Assiut University

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.

研究概览

详细说明

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.

研究类型

观察性的

注册 (估计的)

50

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不适用

取样方法

非概率样本

研究人群

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).

描述

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).

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
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.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Dyspnea Severity Score
大体时间: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.
Baseline

次要结果测量

结果测量
措施说明
大体时间
Length of Hospital Stay
大体时间:From the date of hospital admission until the date of hospital discharge, assessed up to 30 days.
The total number of days the patient remains hospitalized for the treatment of the acute exacerbation of COPD.
From the date of hospital admission until the date of hospital discharge, assessed up to 30 days.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年8月1日

初级完成 (估计的)

2027年8月1日

研究完成 (估计的)

2027年9月1日

研究注册日期

首次提交

2026年6月28日

首先提交符合 QC 标准的

2026年7月3日

首次发布 (实际的)

2026年7月9日

研究记录更新

最后更新发布 (实际的)

2026年7月9日

上次提交的符合 QC 标准的更新

2026年7月3日

最后验证

2026年7月1日

更多信息

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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