Ignite Creation Date:
2025-12-26 @ 12:18 PM
Ignite Modification Date:
2026-01-01 @ 2:10 AM
Study NCT ID:
NCT05053100
Status:
COMPLETED
Last Update Posted:
2025-05-02
First Post:
2021-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Understanding the Risk of Blood Clots and Bleeding in Patients With Hematological Malignancies, HAT Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020246', 'term': 'Venous Thrombosis'}, {'id': 'D019337', 'term': 'Hematologic Neoplasms'}, {'id': 'D006689', 'term': 'Hodgkin Disease'}, {'id': 'D009196', 'term': 'Myeloproliferative Disorders'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D009101', 'term': 'Multiple Myeloma'}, {'id': 'D013921', 'term': 'Thrombocytopenia'}], 'ancestors': [{'id': 'D013927', 'term': 'Thrombosis'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D001855', 'term': 'Bone Marrow Diseases'}, {'id': 'D054219', 'term': 'Neoplasms, Plasma Cell'}, {'id': 'D020141', 'term': 'Hemostatic Disorders'}, {'id': 'D010265', 'term': 'Paraproteinemias'}, {'id': 'D001796', 'term': 'Blood Protein Disorders'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D001791', 'term': 'Blood Platelet Disorders'}, {'id': 'D000095542', 'term': 'Cytopenia'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-08-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2024-07-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-29', 'studyFirstSubmitDate': '2021-09-13', 'studyFirstSubmitQcDate': '2021-09-13', 'lastUpdatePostDateStruct': {'date': '2025-05-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Thrombosis incidence', 'timeFrame': 'Up to 1 year', 'description': 'Assessed by incidence of hemorrhage following deep vein thrombosis diagnosis, based on anticoagulant use and presence of thrombocytopenia'}, {'measure': 'Rate of venous thromboembolism (VTE) recurrence', 'timeFrame': 'Up to 1 year', 'description': 'Assessed as the time from admission to the hospital and Venous thrombotic event'}], 'secondaryOutcomes': [{'measure': 'Hemorrhage incidence, without prior thrombosis', 'timeFrame': 'Up to 1 year', 'description': 'Assessed as the time from admission to the hospital until hemorrhage incidence (without prior thrombosis)'}, {'measure': 'Hemorrhage incidence, with prior thrombosis < 12 months', 'timeFrame': 'Within 3 months following deep vein thrombosis diagnosis', 'description': 'Assessed as the time from admission to the hospital until Hemorrhage incidence (with prior thrombosis) \\< 12 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Leukemia', 'Deep Vein Thrombosis', 'Hematopoietic and Lymphoid Cell Neoplasm', 'Hodgkin Lymphoma', 'Myeloproliferative Neoplasm', 'Non-Hodgkin Lymphoma', 'Plasma Cell Myeloma', 'Thrombocytopenia']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.mayo.edu/research/clinical-trials', 'label': 'Mayo Clinic Clinical Trials'}]}, 'descriptionModule': {'briefSummary': 'This study evaluates the risks and experience of blood clots and bleeding in patients with blood cancers. While it is standard of care to use medications to reduce the risk of blood clots in hospitalized individuals, some patients with blood cancers have low platelet counts that can increase the concern for bleeding complications associated with these medications. At this time, the optimal management strategies for blood clots are not well known for patients with blood cancers. This pilot study evaluates additional information that could help doctors know which patients are at highest risk for blood clots.', 'detailedDescription': "PRIMARY OBJECTIVES:\n\nI. Determine the incidence of hemorrhage in the 3 months following deep vein thrombosis diagnosis in hospitalized malignant hematology patients, based on anticoagulant use and presence of thrombocytopenia.\n\nII. Determine recurrent or progressive venous thromboembolism in the 3 months following deep vein thrombosis diagnosis in hospitalized malignant hematology patients, based on anticoagulant use and presence of thrombocytopenia.\n\nSECONDARY OBJECTIVES:\n\nI. Assess feasibility of database creation of patient and clinical characteristics regarding thrombosis and hemorrhage in hospitalized malignant hematology patients.\n\nII. Assess feasibility of patient enrollment and hemostatic laboratory collection pre, during and post treatment.\n\nIII. Describe the impact of thrombocytopenia on resource utilization following thrombosis diagnosis (blood product administration, imaging studies performed, number of days hospitalized).\n\nIV. Describe the impact of therapeutic anticoagulation vs prophylactic anticoagulation on resource utilization following thrombosis diagnosis (blood product administration, imaging studies performed, number of days hospitalized).\n\nV. Define baseline hemostatic characteristics in hospitalized malignant hematology patients prior to chemotherapy and the association with thrombosis or hemorrhage.\n\nVI. Describe changes in laboratory hemostatic characteristics pre-treatment, during treatment and post treatment.\n\nOUTLINE:\n\nPatients' electronic health record are reviewed for 12 months and/or undergo collection of blood at pretreatment and on days 7, 28, 90, and 180."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients admitted to Mayo Clinic Arizona Hematology.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All unique patients, age \\> 18 years old, admitted to the Mayo Clinic Arizona Hematology A and B Service for initiation of 1.) new (or next line) chemotherapy, 2.) autologous stem cell transplant, or 3.) allogeneic stem cell transplant for a hematologic malignancy\n\nExclusion Criteria:\n\n* Solid tumor malignancy patients\n* Age \\< 18'}, 'identificationModule': {'nctId': 'NCT05053100', 'briefTitle': 'Understanding the Risk of Blood Clots and Bleeding in Patients With Hematological Malignancies, HAT Study', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Hemorrhage and Thrombosis in Hematology Malignancies: Understanding the Risks of Thrombosis and Anticoagulation in Patients With Hematologic Malignancies (HAT Trial)', 'orgStudyIdInfo': {'id': 'MC210804'}, 'secondaryIdInfos': [{'id': 'NCI-2021-09154', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': '20-006940', 'type': 'OTHER', 'domain': 'Mayo Clinic Institutional Review Board'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Observational (record review, blood collection)', 'description': "Patients' electronic health record are reviewed for 12 months and/or undergo collection of blood at pretreatment and on days 7, 28, 90, and 180.", 'interventionNames': ['Procedure: Biospecimen Collection', 'Other: Electronic Health Record Review']}], 'interventions': [{'name': 'Biospecimen Collection', 'type': 'PROCEDURE', 'otherNames': ['Biological Sample Collection'], 'description': 'Undergo collection of blood', 'armGroupLabels': ['Observational (record review, blood collection)']}, {'name': 'Electronic Health Record Review', 'type': 'OTHER', 'description': 'Undergo electronic health record review', 'armGroupLabels': ['Observational (record review, blood collection)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85259', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Mayo Clinic in Arizona', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}], 'overallOfficials': [{'name': 'Leslie J. Padrnos, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}