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

NCT07197333 | Not Yet Recruiting

• 1 other identifier: Predictors of DVT
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Platelet Distribution Width; Mean Platelet Volume

Keywords

platelet distribution width; mean platelet volume

Outcome Measures

Primary Outcomes (1)

• Incidence of DVT during ICU stay

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

  one day

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Adults ≥18 years
• Admitted to ICU at Assiut University Hospital
• Mechanically ventilated for ≥48 hours

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

Related Publications (1)

• 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

  BACKGROUND

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: resident at the Critical Care Medicine department

Study Record Dates

• First Submitted: September 20, 2025
• First Posted: September 29, 2025
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: September 29, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share