Skip to main content
OpenTrials
Not yet recruiting

NCT Number: NCT07832903

Serial Platelet Count and Indices for Predicting In-Hospital Mortality in Sepsis

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.

Not yet recruiting

Trial opening soon.

Get Notified

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

  • 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.

Treatment and study plan

Serial Complete Blood Counts (CBC)

Diagnostic Test

Routine automated complete blood counts, including platelet count (PC) and mean platelet volume (MPV), collected serially during the first 7-14 days of admission. These are used to evaluate biological trajectories and calculate derived indices (MPV/PC, PLR, CRP/PLT, and PLT/Cr)

Primary outcomes

  1. In-hospital mortality

    Time frame: 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).

Interested in participating?

Not yet recruiting

Trial opening soon.

Get Notified

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Sep 22, 2026
Registry last updated
Sep 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.