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Not yet recruitingNCT06993623Updated Sep 23, 2025

Heparin Binding Protein Versus Platelet Count and Mean Platelet Volume Kinetics in the Diagnosis and Prognosis of VAP

An observational study in Ventilator Associated Pneumonia (VAP), sponsored by Esraa Hamdy Thabit Riad. Not yet recruiting at 1 site in Egypt. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-09-23.

Sponsored by Esraa Hamdy Thabit Riad · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
80
Ages
18 Years to 70 Years
Sex
All
01

Study summary

mechanically ventilated for 48 hours or more and subsequently develop ventilator-associated pneumonia (VAP). After obtaining approval from the local ethical committee at the Faculty of Medicine, El-Minia University, and informed consent from first-degree relatives, patients will be enrolled and classified into two groups based on clinical outcomes: Group A (survivors with successful extubation) and Group B (non-survivors with prolonged mechanical ventilation and/or 30-day mortality). Prolonged mechanical ventilation (PMV) is defined as ≥21 days of ventilation. Blood samples will be collected from participants to measure heparin-binding protein (HBP), mean platelet volume (MPV), and the MPV-to-platelet count (PC) ratio. Laboratory analysis will be blinded to the clinical outcome group to ensure objectivity. The study aims to investigate the potential of these biomarkers in predicting prognosis and guiding clinical decisions in patients with VAP.

Read the detailed description

This prospective, single-blinded observational study aims to investigate the prognostic value of heparin-binding protein (HBP), mean platelet volume (MPV) kinetics, and the MPV-to-platelet count (PC) ratio in adult patients with ventilator-associated pneumonia (VAP). The study will be conducted on 80 adult patients (aged >18 and \<70 years) admitted to the intensive care unit (ICU) at El-Minia University Hospitals. Eligible patients must have been mechanically ventilated for more than 48 hours and meet the diagnostic criteria for VAP based on clinical and radiological data, including a Modified Clinical Pulmonary Infection Score (CPIS) >6. The CPIS will be calculated without including microbiological culture results.

After obtaining ethical approval and informed consent from first-degree relatives, patients will be enrolled and classified retrospectively into two groups based on clinical outcomes:

Group A: Survivors (patients who undergo successful extubation).

Group B: Non-survivors (patients requiring prolonged mechanical ventilation-defined as ≥21 days-and/or those who die within 30 days of diagnosis).

Blood samples will be collected and tested for HBP, MPV kinetics, and the MPV/PC ratio. All laboratory analyses will be performed in a blinded manner to eliminate bias, as the clinical pathologist will not be informed of the patient group classification.

The primary objective of this study is to evaluate whether these biomarkers can predict clinical outcomes and assist in the risk stratification of patients with VAP.

Exclusion criteria include patients with:

Pre-existing infections or sepsis at the time of ICU admission.

Underlying conditions that may affect platelet function or morphology (e.g., cancer, chronic liver disease, end-stage renal disease).

Primary hematologic disorders, including disseminated intravascular coagulation.

Severe thrombocytopenia (platelet count ≤20×10⁹/L) or those receiving platelet transfusions.

The study aims to generate insights that may guide future prognostic and therapeutic strategies in managing critically ill patients with VAP.

02

Conditions studied

  • Ventilator Associated Pneumonia (VAP)
03

In context

Pneumonia, Ventilator-Associated

392 studies on the registry are indexed under Pneumonia, Ventilator-Associated; 81 are open to participants now.

This study's planned enrollment of 80 is below the median of 140 across 127 observational studies indexed under Pneumonia, Ventilator-Associated.

Browse Pneumonia, Ventilator-Associated studies →

Lead sponsor

This is the only study on the registry with Esraa Hamdy Thabit Riad as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Adult patients (aged 18-70 years) admitted to the intensive care unit (ICU) at El-Minia University Hospitals, who are mechanically ventilated for more than 48 hours and subsequently develop ventilator-associated pneumonia (VAP). All participants must fulfill the clinical and radiological criteria for VAP with a Modified Clinical Pulmonary Infection Score (CPIS) >6.

Inclusion criteria

  • 1. Patients \< 18 years old\<70years 2. MV for more than 48 h. 3 . Signs of VAP according to clinical and radiological data , Modified Clinical Pulmonary Infection Score (CPIS) will be calculated for the patients and will be included when CPIS > 6 . Modified CPIS will be calculated without considering culture results.(12)

Exclusion criteria

Exclusion Criteria:

- . Patients with pre-existing infections or sepsis at ICU admission. 2. Patients with underlying conditions such cancer, chronic liver illnesses, end-stage renal disease, etc. that may impact platelet function or morphology.

3. primary hematological disorders, disseminated intravascular coagulation. 4.severe thrombocytopenia (platelet count ≤ 20x109 L-1) and receiving platelet transfusion.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
80 participants (estimated)
Patient registry
No

Interventions

  • Diagnostic testheparin binding protien

    compare between Heparin binding protien and platelet count and mean platelet volume kinetics in diagnosis and prognosis of VAP

06

What researchers measure

Primary outcomes

  1. HBP levels in survivors and non survivors patients of VAP measured by ng\ ml using ElISAImmunoassay

    To determine whether elevated HBP levels , change in platelet count and mean platelet volume kinetics are associated with mortality and prolonged mechanical ventilation in patients with VAP.

    Time frame: within 30 days after VAP diagnosis

07

Study locations

1 site
  • Minia university Hospitals
    Minya, Egypt
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 23, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06993623
Lead sponsor
Esraa Hamdy Thabit Riad
Responsible party
Esraa Hamdy Thabit Riad (Assistant lecturer of anesthesiology and ICU, Minia University) — Sponsor-investigator
First posted
May 29, 2025
Start date
Sep 2025 (estimated)
Primary completion
Oct 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
Sep 23, 2025

Study contacts

Esraa Hamdy Thabit
Contact
dr.esohamdy@gmail.com
00201092750558
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

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