Ventilator Associated Pneumonia (VAP)NCT06993623
Heparin Binding Protein Versus Platelet Count and Mean Platelet Volume Kinetics in the Diagnosis and Prognosis of VAP
An observational study of Ventilator Associated Pneumonia (VAP), run by Esraa Hamdy Thabit Riad at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Ventilator Associated Pneumonia (VAP)
- What is being tested?
- heparin binding protien
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- Sep 2025to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- . 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Heparin Binding Protein Versus Platelet Count and Mean Platelet Volume Kinetics as Indicators for Diagnosis and Prognosis of Ventilator Associated Pneumonia
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.
- Conditions
- Ventilator Associated Pneumonia (VAP)
- Being tested
- heparin binding protien
- Medical subject headings
- Pneumonia, Ventilator-Associated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
heparin binding protienDiagnostic test
compare between Heparin binding protien and platelet count and mean platelet volume kinetics in diagnosis and prognosis of VAP
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: within 30 days after VAP diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2025
- Study startSep 2025 (estimated)
- Primary completionOct 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventilator Associated Pneumonia (VAP)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Esraa Hamdy Thabit Riad
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Esraa Hamdy Thabit Riad, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06993623
- Sponsor's protocol ID
- 1489/03/2025
- Status last verified
- Mar 2025
- First submitted
- 1 May 2025
- Last updated
- 23 Sep 2025
- Results posted
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heparin Binding Protein Versus Platelet Count and Mean Platelet Volume Kinetics as Indicators for Diagnosis and Prognosis of Ventilator Associated Pneumonia
- ClinicalTrials.gov ID
- NCT06993623
- Acronym / sponsor ID
- 1489/03/2025
- Conditions
- Ventilator Associated Pneumonia (VAP)
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Esraa Hamdy Thabit RiadUniversity, hospital or other
- Study start
- Sep 2025 (estimated)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 29 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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)
Key exclusion criteria (2 listed)
- . 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| heparin binding protiencompare between Heparin binding protien and platelet count and mean platelet volume kinetics in diagnosis and prognosis of VAP | Diagnostic test | – |
Primary outcome
HBP levels in survivors and non survivors patients of VAP measured by ng\ ml using ElISAImmunoassay
Time frame: within 30 days after VAP diagnosis
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Ventilator Associated Pneumonia (VAP)
Not yet recruitingObservational study
Early Identification of Pathogens in Children With Respiratory Tract Infection by Mechanical Ventilation Using mNGS
VAP - Ventilator Associated Pneumonia
Recruiting
Immediate Versus Substantiated Antibiotic Therapy in Suspected Non-Severe Ventilator-Associated Pneumonia
Ventilator-Associated Pneumonia (VAP)
Recruiting
Effect of Ventilator Hyperinflation Combined With Body Positioning on ABG in VAP
Ventilator Associated Bacterial Pneumonia (VABP), Critical Illness
Active, not recruiting
HAP/VAP Diagnosis in Critically Ill Septic Patients Using a Multiplex PCR Array
HAP - Hospital Acquired Pneumonia, VAP - Ventilator Associated Pneumonia
RecruitingPhase 4
Combined Use of a Respiratory Multiplex PCR and Algorithm-based Therapy to Improve Early Optimization of Antibiotic Therapy in Critically Ill Patients With Ventilator-associated Pneumonia
Ventilator Associated Pneumonia ( VAP)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ventilator Associated Pneumonia (VAP), run by Esraa Hamdy Thabit Riad at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Esraa Hamdy Thabit (00201092750558, dr.esohamdy@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HBP levels in survivors and non survivors patients of VAP measured by ng\ ml using ElISAImmunoassay (time frame: within 30 days after VAP diagnosis). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2025.