Platelet Distribution WidthNCT07197333
Early Platelet Indices as Biomarkers of Deep Vein Thrombosis and Prognostic Markers in Mechanically Ventilated ICU Patients
An observational study of Platelet Distribution Width and Mean Platelet Volume, run by Assiut University.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Platelet Distribution Width, Mean Platelet Volume
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to 30 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Adults ≥18 years
- Admitted to ICU at Assiut University Hospital
- Mechanically ventilated for ≥48 hours
Who cannot join
- 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
About this study
Official 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
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.
- Conditions
- Platelet Distribution Width, Mean Platelet Volume
- Keywords
- platelet distribution width, mean platelet volume
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of DVT during ICU stay
Percentage of patients developing DVT as confirmed by Doppler ultrasound during ICU admission
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2025
- Study start1 Sep 2026 (estimated)
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Platelet Distribution WidthStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roiea Abd El Reheem Aref, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07197333
- Sponsor's protocol ID
- Predictors of DVT
- Status last verified
- Sep 2025
- First submitted
- 20 Sep 2025
- Last updated
- 29 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07197333
- Acronym / sponsor ID
- Predictors of DVT
- Conditions
- Platelet Distribution Width, Mean Platelet Volume
- Keywords
- platelet distribution width, mean platelet volume
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 29 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Adults ≥18 years
- Admitted to ICU at Assiut University Hospital
- Mechanically ventilated for ≥48 hours
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of DVT during ICU stay
Time frame: one day
Percentage of patients developing DVT as confirmed by Doppler ultrasound during ICU admission
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2025.
- BackgroundZhou 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 dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Platelet Distribution Width and Mean Platelet Volume, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of DVT during ICU stay (time frame: one day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07197333, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2025.