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

NCT ID: NCT07197333

Last Updated: 2025-09-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2026-09-01

Study Completion Date

2027-12-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Platelet Distribution Width Mean Platelet Volume

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Roiea Abd El Reheem Aref

resident at the Critical Care Medicine department

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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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

Reference Type BACKGROUND

Other Identifiers

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Predictors of DVT

Identifier Type: -

Identifier Source: org_study_id

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