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

September 16, 2026 updated by: Ahmed Abdelwahed Abdeljaber Abdelmawjood, Assiut University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult patients admitted to the hospital or Intensive Care Unit (ICU) at Assiut University Hospitals who are diagnosed with sepsis.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: COHORT
  • Time Perspectives: PROSPECTIVE

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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)
Diagnostic test: Serial Complete Blood Counts (CBC)

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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
From hospital admission until hospital discharge, assessed up to 28 days.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 1, 2026

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

September 16, 2026

First Submitted That Met QC Criteria

September 16, 2026

First Posted (Actual)

September 22, 2026

Study Record Updates

Last Update Posted (Actual)

September 22, 2026

Last Update Submitted That Met QC Criteria

September 16, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Serial platelets in sepsis

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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