Ignite Creation Date:
2025-12-24 @ 10:07 PM
Ignite Modification Date:
2025-12-31 @ 1:24 PM
Study NCT ID:
NCT01933035
Status:
COMPLETED
Last Update Posted:
2016-05-17
First Post:
2013-08-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Extended Platelet Parameters as a Means to Differentiate Immune Thrombocytopenia From Hypo-proliferative Thrombocytopenias.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016553', 'term': 'Purpura, Thrombocytopenic, Idiopathic'}, {'id': 'D000754', 'term': 'Anemia, Refractory, with Excess of Blasts'}, {'id': 'D000741', 'term': 'Anemia, Aplastic'}, {'id': 'D013921', 'term': 'Thrombocytopenia'}], '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': 'D001791', 'term': 'Blood Platelet Disorders'}, {'id': 'D000095542', 'term': 'Cytopenia'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'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'}, {'id': 'D000753', 'term': 'Anemia, Refractory'}, {'id': 'D000740', 'term': 'Anemia'}, {'id': 'D009190', 'term': 'Myelodysplastic Syndromes'}, {'id': 'D001855', 'term': 'Bone Marrow Diseases'}, {'id': 'D000080983', 'term': 'Bone Marrow Failure Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C083299', 'term': '1-methyl-1-piperidinomethane sulfonate'}, {'id': 'D011155', 'term': 'Population Control'}], 'ancestors': [{'id': 'D011157', 'term': 'Population Dynamics'}, {'id': 'D003710', 'term': 'Demography'}, {'id': 'D011154', 'term': 'Population Characteristics'}, {'id': 'D015991', 'term': 'Epidemiologic Measurements'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': "Study subjects will have the following collected: Lavender tri-potassium EDTA tubes filled according to the manufacturer's specifications \\[approximately 4ML of venous blood\\], labeled, and promptly dispatched to the laboratory.The sample will be gently inverted several times prior to analysis on the ADVIA 120 taking care not to overly agitate the sample. Moreover, the specimen shall be inspected for clot formation prior to being assayed. The full blood count shall be obtained and in the configuration sub-menu the extended platelet parameter option shall be selected and thus actuated. A print out will be generated including the MPC, MPM, platelet component distribution width, platelet mass distribution width, and large platelet count in addition to the standard platelet count and mean platelet volume \\[MPV\\]."}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}, 'targetDuration': '12 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-05-16', 'studyFirstSubmitDate': '2013-08-28', 'studyFirstSubmitQcDate': '2013-08-28', 'lastUpdatePostDateStruct': {'date': '2016-05-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-08-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Platelet mass distribution width', 'timeFrame': '12 Months'}], 'primaryOutcomes': [{'measure': 'Increased platelet density', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'mean platelet mass', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['ITP', 'Thrombocytopenia', 'mean platelet mass', 'mean platelet component'], 'conditions': ['Immune Thrombocytopenia', 'Chemotherapy Induced Thrombocytopenia', 'Myelodysplasia', 'Aplastic Anaemia']}, 'descriptionModule': {'briefSummary': 'To utilise extended platelet parameters in order to individuate Immune Thrombocytopenia (ITP) from hypo-proliferative causes of thrombocytopenia.\n\nTo develop the clinical potential of the extended platelet parameters as they pertain to distinguishing different causes of thrombocytopenia from one another.\n\nTo test the hypothesis that mean platelet component (MPC) and mean platelet mass (MPM) might distinguish between thrombocytopenia related to bone marrow dysfunction and immune mediated destruction of platelets.', 'detailedDescription': 'Patient to be registered at the Haematology-Oncology department Mount Sinai Roosevelt Hospital.\n\nInclusion criteria are as follows:\n\nAll individuals age 18yrs and above capable of rendering consent Known ITP confirmed by response to IVIG, glucocorticoids, or WinRho and exclusion of all other possible causes of thrombocytopenia Confirmed aplastic anemia \\[as assessed through bone marrow trephine biopsy\\]. Chemotherapy-induced thrombocytopenia assessed at time of predicted nadir.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population would consist of adult female and male subjects of all ethnic persuasions in good general health apart from thrombocytopenia, bone marrow aplasia, myelodysplasia, or active malignancy requiring therapy. Vulnerable strata of the hospital population will not be recruited into the study.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All individuals age 18yrs and above capable of rendering consent\n* Known ITP confirmed by response to intravenous immune globulin (IVIG), glucocorticoids, or winRho and exclusion of all other possible causes of thrombocytopenia\n* Confirmed aplastic anemia \\[as assessed through bone marrow trephine biopsy\\]\n* Chemotherapy induced thrombocytopenia assessed at time of predicted nadir.\n\nExclusion Criteria:\n\n* Suspected multifactorial thrombocytopenias and thrombocytopenia due to hypersplenism\n* Chronic active hepatitis\n* Those infected with HIV\n* Patients receiving concomitant radiotherapy\n* Gravid females\n* Congenital thrombocytopenias'}, 'identificationModule': {'nctId': 'NCT01933035', 'briefTitle': 'Extended Platelet Parameters as a Means to Differentiate Immune Thrombocytopenia From Hypo-proliferative Thrombocytopenias.', 'organization': {'class': 'OTHER', 'fullName': 'Beth Israel Medical Center'}, 'officialTitle': 'Extended Platelet Parameters as a Means to Differentiate Immune Thrombocytopenia From Hypo-proliferative Thrombocytopenias.', 'orgStudyIdInfo': {'id': '13-0134'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Immune Thrombocytopenics', 'description': 'The study shall be a single institution prospective cohort study. Comparison will be made among individuals with known ITP . Those with known hypo-proliferative forms of thrombocytopenia \\[aplastic anaemia, chemotherapy induced thrombocytopenia, and myelodysplastic thrombocytopenia, and a control population.', 'interventionNames': ['Other: Immune Thrombocytopenics']}, {'label': 'Hypo-proliferative thrombocytopenics', 'description': 'The study shall be a single institution prospective cohort study. Comparison will be made between individuals with known ITP versus those with known hypo-proliferative forms of thrombocytopenia \\[aplastic anaemia, chemotherapy--induced thrombocytopenia, and myelodysplastic thrombocytopenia\\], and a control population.', 'interventionNames': ['Other: Hypo-proliferative thrombocytopenics']}, {'label': 'Control Pupulation', 'description': 'comprised of healthy individuals with normal platelet counts, to confirm normal values for MPC and MPM', 'interventionNames': ['Other: Control Population']}], 'interventions': [{'name': 'Immune Thrombocytopenics', 'type': 'OTHER', 'otherNames': ['MPC (g/dl)', 'MPM (pg)'], 'description': 'Full blood count with extended platelet parameters', 'armGroupLabels': ['Immune Thrombocytopenics']}, {'name': 'Hypo-proliferative thrombocytopenics', 'type': 'OTHER', 'otherNames': ['MPC (g/dl)', 'MPM (pg)'], 'description': 'Full blood count with extended platelet parameters', 'armGroupLabels': ['Hypo-proliferative thrombocytopenics']}, {'name': 'Control Population', 'type': 'OTHER', 'otherNames': ['MPC (g/dl)', 'MPM (pg)'], 'description': 'Full blood count with extended platelet parameters', 'armGroupLabels': ['Control Pupulation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10019', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Roosevelt Hospital', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Mala Varma, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beth Israel Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beth Israel Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}