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

NCT06993623 | Not Yet Recruiting

• 1 other identifier: 1489/03/2025
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ventilator Associated Pneumonia (VAP)

Outcome Measures

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.

  within 30 days after VAP diagnosis

Interventions

heparin binding protien DIAGNOSTIC_TEST

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

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• \. 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)

You may not qualify if:

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

Sponsors & Collaborators

• Esraa Hamdy Thabit Riad: lead

Study Sites (1)

Minia university Hospitals

Minya, Egypt

Location

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated

Condition Hierarchy (Ancestors)

Healthcare-Associated Pneumonia; Cross Infection; Infections; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Esraa Hamdy Thabit

CONTACT

00201092750558; dr.esohamdy@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant lecturer of anesthesiology and ICU

Study Record Dates

• First Submitted: May 1, 2025
• First Posted: May 29, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 23, 2025

Record last verified: 2025-03

Locations

EG (1)