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NCT Number: NCT07197333

Early Platelet Indices as Biomarkers of Deep Vein Thrombosis and Prognostic Markers in Mechanically Ventilated ICU Patients

This prospective observational study aims to evaluate the role of mean platelet volume (MPV) and platelet distribution width (PDW) as early indicators of deep vein thrombosis (DVT) and as prognostic markers in mechanically ventilated Intensive Care Unit (ICU) patients.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

The study will be conducted at the Critical Care Unit of Assiut University Hospital and will recruit 100 mechanically ventilated patients. Deep venous thrombosis (DVT) remains a major challenge in ICU patients due to the difficulty in clinical detection. Conventional tools such as Doppler ultrasound and D-dimer testing have significant limitations, creating a need for cost-efficient, accessible biomarkers. MPV and PDW are promising markers of platelet activation and variability, both of which play central roles in thrombus formation. These indices are routinely included in complete blood count (CBC) tests, making them widely accessible.

The study will explore whether elevated MPV and PDW values at ICU admission and during follow-up are associated with higher incidence of DVT and increased ICU mortality. Patients will undergo baseline investigations, followed by repeated platelet measurements every 48 hours until ICU discharge or death. Doppler ultrasound assessments will be done on Day 5-7 or earlier if symptoms suggest thrombosis.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults ≥18 years

Admitted to ICU at Assiut University Hospital

Mechanically ventilated for ≥48 hours

Exclusion criteria

  • Known hematological malignancy or platelet disorders

Recent platelet transfusion within 7 days

Known pre-existing deep vein thrombosis

Previous anticoagulation treatment prior to ICU admission

Pregnancy

Treatment and study plan

Primary outcomes

  1. Incidence of DVT during ICU stay

    Time frame: one day

    Percentage of patients developing DVT as confirmed by Doppler ultrasound during ICU admission

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Mean Platelet Volume and Platelet Distribution Width as Early Indicators of Deep Vein Thrombosis and Prognostic Markers in Mechanically Ventilated Intensive Care Unit Patients

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 29, 2025
Registry last updated
Sep 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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