Ignite Creation Date:
2025-12-24 @ 4:25 PM
Ignite Modification Date:
2025-12-29 @ 6:02 AM
Study NCT ID:
NCT05654766
Status:
UNKNOWN
Last Update Posted:
2022-12-16
First Post:
2022-12-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assesment of the Functional Activity of Platelets for the Differential Diagnosis of Thrombocytopathies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016553', 'term': 'Purpura, Thrombocytopenic, Idiopathic'}, {'id': 'D001791', 'term': 'Blood Platelet Disorders'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}], 'ancestors': [{'id': 'D011696', 'term': 'Purpura, Thrombocytopenic'}, {'id': 'D011693', 'term': 'Purpura'}, {'id': 'D001778', 'term': 'Blood Coagulation Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D057049', 'term': 'Thrombotic Microangiopathies'}, {'id': 'D013921', 'term': 'Thrombocytopenia'}, {'id': 'D000095542', 'term': 'Cytopenia'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012877', 'term': 'Skin Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005434', 'term': 'Flow Cytometry'}, {'id': 'D010974', 'term': 'Platelet Aggregation'}], 'ancestors': [{'id': 'D002469', 'term': 'Cell Separation'}, {'id': 'D003584', 'term': 'Cytological Techniques'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D003592', 'term': 'Cytophotometry'}, {'id': 'D005470', 'term': 'Fluorometry'}, {'id': 'D008163', 'term': 'Luminescent Measurements'}, {'id': 'D010783', 'term': 'Photometry'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D018056', 'term': 'Hemorheology'}, {'id': 'D001790', 'term': 'Blood Physiological Phenomena'}, {'id': 'D002943', 'term': 'Circulatory and Respiratory Physiological Phenomena'}, {'id': 'D015539', 'term': 'Platelet Activation'}, {'id': 'D006487', 'term': 'Hemostasis'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Whole blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-01-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-12-08', 'studyFirstSubmitDate': '2022-12-08', 'studyFirstSubmitQcDate': '2022-12-08', 'lastUpdatePostDateStruct': {'date': '2022-12-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Expression of CD42b by platelets', 'timeFrame': 'baseline', 'description': 'Assessment of platelet functional activity by the detection of CD42b'}, {'measure': 'Expression of CD41 by platelets', 'timeFrame': 'baseline', 'description': 'Assessment of platelet functional activity by the detection of CD41'}, {'measure': 'Expression of PAC-1 by platelets', 'timeFrame': 'baseline', 'description': 'Assessment of platelet functional activity by the detection of PAC-1'}, {'measure': 'Expression of CD63 by platelets', 'timeFrame': 'baseline', 'description': 'Assessment of platelet functional activity by the detection of CD63'}, {'measure': 'Expression of CD62p by platelets', 'timeFrame': 'baseline', 'description': 'Assessment of platelet functional activity by the detection of CD62p'}, {'measure': 'Expression of Annexin V by platelets', 'timeFrame': 'baseline', 'description': 'Assessment of platelet functional activity by the detection of Annexin V'}, {'measure': 'Level of platelet aggregation', 'timeFrame': 'baseline', 'description': 'Assessment of platelet functional activity by turbidimetric aggregometry'}, {'measure': 'Impedance of platelet aggregates', 'timeFrame': 'baseline', 'description': 'Assessment of platelet functional activity by impedance aggregometry'}, {'measure': 'Fibrinogen level', 'timeFrame': 'baseline', 'description': 'Assessment of blood coagulation using Fibrinogen level test'}, {'measure': 'Prothrombin test', 'timeFrame': 'baseline', 'description': 'Assessment of blood coagulation using Prothrombin test'}, {'measure': 'Thrombin time', 'timeFrame': 'baseline', 'description': 'Assessment of blood coagulation using Thrombin time test'}, {'measure': 'aPTT', 'timeFrame': 'baseline', 'description': 'Assessment of blood coagulation using aPTT'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Immune Thrombocytopenia', 'Thrombocytopathy', 'Acute Leukemia', 'Hemorrhagic Disorders']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to develop a highly sensitive method for assessing the functional activity of platelets for use in the differential diagnosis of thrombocytopenia and platelet defects.', 'detailedDescription': 'The purpose of this study is to develop a highly sensitive method for assessing the functional activity of platelets using flow cytometry and turbidimetric and impedance aggregometry for use in the differential diagnosis of thrombocytopenia and platelet defects'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '1 Year', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy pediatric volunteers aged 1 to 17. Pediatric volunteers aged 1 to 17 with any manifestation of hemorrhagic syndrome.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pediatric participants with hemorrhagic syndrome (hemorrhagic rash, bruising, bleeding, increased bleeding of the skin and mucous membranes, spontaneous hemorrhages in soft tissues and joints)\n* Pediatric participants with acute leukemia\n* Parameters of the plasma level of blood coagulation correspond to the age normal levels\n\nExclusion Criteria:\n\n* Anticoagulation drug therapy\n* Antiaggregation drug therapy\n* Biologically active additives'}, 'identificationModule': {'nctId': 'NCT05654766', 'briefTitle': 'Assesment of the Functional Activity of Platelets for the Differential Diagnosis of Thrombocytopathies', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus'}, 'officialTitle': 'Development of a Method for Assessing the Functional Activity of Platelets for the Differential Diagnosis of Thrombocytopathies Using Flow Cytometry', 'orgStudyIdInfo': {'id': 'IBCE_PL1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Control group', 'description': 'Group of healthy adult and pediatric participants, whose blood platelets will be used to evaluate normal ranges of parameters in the flow cytometry PFT.', 'interventionNames': ['Diagnostic Test: Flow cytometry', 'Diagnostic Test: Platelet aggregation and plasma coagulation']}, {'label': 'Hemorrhagic syndrome and Acute Leukemia', 'description': 'Group of pediatric participants with any manifestations of hemorrhagic syndrome and/or acute leukemia', 'interventionNames': ['Diagnostic Test: Flow cytometry', 'Diagnostic Test: Platelet aggregation and plasma coagulation']}], 'interventions': [{'name': 'Flow cytometry', 'type': 'DIAGNOSTIC_TEST', 'description': 'Parameters such as FSC, SSC, median fluorescence of anti CD42b, PAC-1, CD41, CD63, CD62P, as well as Annexin V fluorescence will be assessed.', 'armGroupLabels': ['Control group', 'Hemorrhagic syndrome and Acute Leukemia']}, {'name': 'Platelet aggregation and plasma coagulation', 'type': 'DIAGNOSTIC_TEST', 'description': 'Turbodimetric platelet aggregation test, impedance platelet aggregation test. Standard plasma coagulation test (fibrinogen level, prothrombin test, thrombin time, activated partial thromboplastin time (aPTT)).', 'armGroupLabels': ['Control group', 'Hemorrhagic syndrome and Acute Leukemia']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Ekaterina Shamova, Dr', 'role': 'CONTACT', 'email': 'lubakova@gmail.com', 'phone': '+375297520785'}, {'name': 'Viacheslav Dmitriev, Dr', 'role': 'CONTACT', 'email': 'rrchypp@gmail.com', 'phone': '+375296592670'}], 'overallOfficials': [{'name': 'rrchypp@gmail.com Shamova, Dr', 'role': 'STUDY_DIRECTOR', 'affiliation': 'the Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus'}, {'name': 'Viacheslav Dmitriev, Dr', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Belarussian Research Center for Pediatric Oncology, Hematology and Immunology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Belarusian Research Center for Pediatric Oncology, Hematology and Immunology', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}