Ignite Creation Date:
2025-12-25 @ 2:44 AM
Ignite Modification Date:
2025-12-26 @ 1:23 AM
Study NCT ID:
NCT07197333
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-29
First Post:
2025-09-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Early Platelet Indices as Biomarkers of Deep Vein Thrombosis and Prognostic Markers in Mechanically Ventilated ICU Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2027-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-20', 'studyFirstSubmitDate': '2025-09-20', 'studyFirstSubmitQcDate': '2025-09-20', 'lastUpdatePostDateStruct': {'date': '2025-09-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of DVT during ICU stay', 'timeFrame': 'one day', 'description': 'Percentage of patients developing DVT as confirmed by Doppler ultrasound during ICU admission'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['platelet distribution width', 'mean platelet volume'], 'conditions': ['Platelet Distribution Width', 'Mean Platelet Volume']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': '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'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults ≥18 years\n\nAdmitted to ICU at Assiut University Hospital\n\nMechanically ventilated for ≥48 hours\n\nExclusion Criteria:\n\n* Known hematological malignancy or platelet disorders\n\nRecent platelet transfusion within 7 days\n\nKnown pre-existing deep vein thrombosis\n\nPrevious anticoagulation treatment prior to ICU admission\n\nPregnancy'}, 'identificationModule': {'nctId': 'NCT07197333', 'briefTitle': 'Early Platelet Indices as Biomarkers of Deep Vein Thrombosis and Prognostic Markers in Mechanically Ventilated ICU Patients', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Mean Platelet Volume and Platelet Distribution Width as Early Indicators of Deep Vein Thrombosis and Prognostic Markers in Mechanically Ventilated Intensive Care Unit Patients', 'orgStudyIdInfo': {'id': 'Predictors of DVT'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Adult critically ill patients aged ≥18 years admitted to the ICU of Assiut University Hospital who r', 'description': '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.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'resident at the Critical Care Medicine department', 'investigatorFullName': 'Roiea Abd El Reheem Aref', 'investigatorAffiliation': 'Assiut University'}}}}