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临床试验/NCT07832903
NCT07832903尚未招募不适用

Predictive Value of Serial Platelet Count, and Platelet Indices for In-Hospital Mortality in Patients With Sepsis: A Cohort Study

Assiut University0 个研究点目标入组 120 人开始时间: 2026年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
120
主要终点
In-hospital mortality

研究概览

简要总结

This observational study aims to determine if tracking changes in blood platelets over time can help predict the clinical outcomes of adult patients hospitalized with sepsis. While current medical scoring systems (like SOFA and APACHE) help doctors evaluate a patient's risk when they are first admitted, they are often static and may not capture how the body's response changes during the infection. Platelet count and the size of the platelets (mean platelet volume) change dynamically during sepsis.

Researchers will observe the routine daily blood test results of adult sepsis patients during their first 7 to 14 days in the hospital to track these changes. By calculating specific platelet ratios and analyzing their trajectories, the study hopes to find out if these simple, cost-effective markers can accurately predict a patient's risk of in-hospital mortality, and if they can improve the accuracy of current standard severity scores.

详细描述

During sepsis, platelet count (PC) and mean platelet volume (MPV) act as dynamic markers reflecting systemic inflammation, platelet consumption, marrow response, and platelet activation. Current prognostic tools, such as the SOFA and APACHE II/IV scores, provide important baseline risk stratification but are relatively static and may not fully capture the evolving host response to infection.

Emerging evidence indicates that serial platelet indices yield greater prognostic information than single, baseline measurements. Furthermore, composite platelet-derived metrics-such as the MPV/PC ratio, platelet-to-lymphocyte ratio (PLR), CRP-to-platelet ratio (CRP/PLT), and platelet-to-creatinine ratio (PLT/Cr)-integrate signals of inflammation, haemostasis, and organ dysfunction, which may enhance clinical risk prediction. Despite these signals, few prospective studies have simultaneously examined the serial trajectories of PC and MPV, their derived ratios, and their incremental value beyond conventional severity scores.

This prospective cohort study hypothesizes that serial PC and MPV dynamics, along with derived platelet ratios, independently predict in-hospital mortality in adults with sepsis after adjusting for clinical confounders. Demonstrating independent prognostic value and improved reclassification when these trajectory-based markers are combined with SOFA or APACHE scores would support incorporating routine, time-updated platelet indices into sepsis prognostication and risk-stratified management.

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
否

入选标准

  • •Adults (>18 years).
  • •Admitted to the hospital/ICU with sepsis as defined by Sepsis-3 criteria (suspected/proven infection plus an acute increase in SOFA score >= 2).

排除标准

  • •Age <18 years.
  • •Known hematologic malignancy with active chemotherapy affecting platelets.
  • •Platelet transfusion within 24 hours before the first platelet measurement.
  • •Chronic thrombocytopenia from non-sepsis causes (e.g., immune thrombocytopenia).
  • •Missing core baseline data (e.g., date of admission, vital status).
  • •Declined consent.

研究组 & 干预措施

Adult Sepsis Cohort

Adult patients (older than 18 years) admitted to the hospital or Intensive Care Unit (ICU) who are diagnosed with sepsis according to Sepsis-3 criteria (suspected or proven infection plus an acute increase in SOFA score of 2 or more)

干预措施: Serial Complete Blood Counts (CBC) (Diagnostic Test)

结局指标

主要结局

In-hospital mortality

时间窗: From hospital admission until hospital discharge, assessed up to 28 days.

Death of the patient from any cause prior to hospital discharge, evaluated as a binary outcome (survivor vs. non-survivor).

次要结局

未报告次要终点

研究者

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

Ahmed Abdelwahed Abdeljaber Abdelmawjood

Resident Doctor

Assiut University

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