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Not yet recruitingNCT07197333Updated Sep 29, 2025

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

An observational study in Platelet Distribution Width and Mean Platelet Volume, sponsored by Assiut University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-29.

Sponsored by Assiut University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
18 Years and older
Sex
All
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Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Platelet Distribution Width
  • Mean Platelet Volume

Keywords

  • platelet distribution width
  • mean platelet volume
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In context

Lead sponsor

Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

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

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

he population will consist of mechanically ventilated ICU patients, a group at particularly high risk of thrombotic events due to immobility, systemic inflammation, and sedation, which limit symptom reporting. Eligible participants must be adults (>18 years) who remain intubated for ≥48 hours. Patients with confounding conditions such as hematological malignancies, congenital platelet disorders, recent platelet transfusions, pre-existing DVT, anticoagulation therapy prior to ICU admission, or pregnancy will be excluded. This selection creates a homogeneous population highly vulnerable to DVT, ideal for assessing the predictive value of MPV and PDW.

Inclusion criteria

  • Adults ≥18 years

Admitted to ICU at Assiut University Hospital

Mechanically ventilated for ≥48 hours

Exclusion criteria

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

05

Study design

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

Groups and cohorts

  • Adult critically ill patients aged ≥18 years admitted to the ICU of Assiut University Hospital who r

    The population will consist of mechanically ventilated ICU patients, a group at particularly high risk of thrombotic events due to immobility, systemic inflammation, and sedation, which limit symptom reporting. Eligible participants must be adults (\>18 years) who remain intubated for ≥48 hours.

06

What researchers measure

Primary outcomes

  1. Incidence of DVT during ICU stay

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

    Time frame: one day

07

Study locations

No study locations are listed for this record.

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References and documents

Publications

  • Zhou Y, Xu Z, Li Z, et al. Mean platelet volume and platelet distribution width as prognostic markers in critically ill patients with sepsis. J Crit Care. 2019;50:213-219. doi:10.1016/j.jcrc.2018.12.003

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 29, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07197333
Lead sponsor
Assiut University
Responsible party
Roiea Abd El Reheem Aref (resident at the Critical Care Medicine department, Assiut University) — Principal investigator
First posted
Sep 29, 2025
Start date
Sep 1, 2026 (estimated)
Primary completion
Sep 30, 2027 (estimated)
Completion
Dec 30, 2027 (estimated)
Last update
Sep 29, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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

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