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Diagnostic and Prognostic Value of Reticulated Platelet Fraction in Ventilator-Associated Pneumonia (REPLAY-VAP)

Diagnostic and Prognostic Value of Reticulated Platelet Fraction in Patients With Ventilator-Associated Pneumonia: A Prospective Observational Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07013032
Acronym
REPLAY-VAP
Enrollment
41
Registered
2025-06-10
Start date
2025-07-01
Completion date
2026-05-12
Last updated
2026-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ventilator-Associated Pneumonia

Brief summary

Ventilator-associated pneumonia (VAP) is a serious infection that occurs in patients who have been on mechanical ventilation for more than 48 hours in the intensive care unit (ICU). Early and accurate diagnosis is critical to reduce complications and improve outcomes. This prospective observational study aims to evaluate the diagnostic and prognostic value of reticulated platelet fraction (RP%) in patients diagnosed with VAP. Blood samples will be taken as part of routine care, and RP% levels will be analyzed using a standard hematology analyzer. The study will investigate whether RP% can help identify VAP earlier and predict outcomes such as mortality and response to antibiotics.

Interventions

None listed

Sponsors

Konya City Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Age 18 years or older * Receiving mechanical ventilation for more than 48 hours * Diagnosed with ventilator-associated pneumonia (VAP) according to clinical, radiologic, and laboratory criteria

Exclusion criteria

* Diagnosis of pneumonia upon ICU admission * Pneumonia as the primary reason for initiation of mechanical ventilation * Mechanical ventilation duration less than 48 hours * Pregnant or breastfeeding patients * Presence of chronic inflammatory conditions, hematologic disorders, malignancy, autoimmune disease, or immunosuppressive/chemotherapy/radiotherapy treatment within the past 4 weeks

Design outcomes

Primary

MeasureTime frameDescription
Diagnostic accuracy of reticulated platelet fraction (RP%) in diagnosing ventilator-associated pneumonia (VAP)Within 48 hours of VAP diagnosisDiagnostic performance of reticulated platelet fraction (RP%) measured as percentage (%) using the Sysmex XN-1000 hematology analyzer (from EDTA-anticoagulated whole blood). The outcome will be evaluated based on sensitivity, specificity, and area under the receiver operating characteristic curve (AUC) for VAP diagnosis, using established clinical and microbiological criteria as the reference standard.

Secondary

MeasureTime frameDescription
Correlation between baseline RP% and 28-day all-cause mortality28 days from VAP diagnosisCorrelation between reticulated platelet fraction (RP%) measured by Sysmex XN-1000 hematology analyzer and 28-day all-cause mortality. Mortality will be recorded as a binary outcome (alive or dead at day 28), and correlation will be assessed using Spearman or point-biserial correlation coefficients, as appropriate.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 14, 2026