Ignite Creation Date:
2025-12-24 @ 4:15 PM
Ignite Modification Date:
2025-12-24 @ 4:15 PM
Study NCT ID:
NCT04320966
Status:
WITHDRAWN
Last Update Posted:
2023-10-31
First Post:
2020-03-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Neurovascular Complications and White Matter Damage in Acquired Anemias
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000740', 'term': 'Anemia'}, {'id': 'D018798', 'term': 'Anemia, Iron-Deficiency'}], 'ancestors': [{'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D000747', 'term': 'Anemia, Hypochromic'}, {'id': 'D000090463', 'term': 'Iron Deficiencies'}, {'id': 'D019189', 'term': 'Iron Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Study was not funded.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2020-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2020-11-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-27', 'studyFirstSubmitDate': '2020-03-16', 'studyFirstSubmitQcDate': '2020-03-23', 'lastUpdatePostDateStruct': {'date': '2023-10-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Impact of acquired anemia on cerebrovascular oxygen delivery (ml O2/100g/min)', 'timeFrame': 'Day 0', 'description': 'Impact of acquired anemia on cerebrovascular oxygen delivery will be assessed by measuring cerebral blood flow and oxygen content through MRI.'}, {'measure': 'Impact of acquired anemia on cerebrovascular flow reactivity (%SI change/%ETCO2)', 'timeFrame': 'Day 0', 'description': 'baseline MRI with blood oxygenation level dependent (BOLD) acquisition will be assessed in response to carbon dioxide exposure to determine whether acquired anemia affects cerebrovascular reserve'}, {'measure': 'Impact of acquired anemia on blood brain barrier permeability surface area product (ml H20/100g/min)', 'timeFrame': 'Day 0', 'description': 'baseline PSA product using water-extraction-with-phase-contrast-arterial-spin-tagging (WEPCAST) MRI will be assessed to determine whether acquired anemia affects blood brain barrier permeability to water'}, {'measure': 'Impact of acquired anemia on cerebral metabolic rate of oxygen (ml O2/100g/min)', 'timeFrame': 'Day 0', 'description': 'T2 relaxation under spin tagging (TRUST) acquisition via MRI will be used to assess any impact of anemia on cerebral metabolic rate of oxygen.'}, {'measure': 'Impact of acquired anemia on total brain blood flow (ml blood/100g/min)', 'timeFrame': 'Day 0', 'description': 'Phase contrast MRI will be assessed to determine whether acquired anemia affects total brain blood flow'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Anemia', 'Iron-deficiency Anemia', 'Healthy Controls']}, 'descriptionModule': {'briefSummary': 'This is an observational trial, in patients with moderate to severe anemia and control subjects. The main purpose of this study is to understand whether normal brain blood flow, oxygen extraction reserve, white matter volumes, and brain functional connectivity are affected by acquired anemia. The investigators will perform baseline MRI monitoring for all subjects. All eligible subjects will be asked to provide informed consent before participating in the study.', 'detailedDescription': 'This is an observational trial, in patients with moderate to severe anemia and control subjects. The main purpose of this study is to understand whether normal brain blood flow, oxygen extraction reserve, white matter volumes, and brain functional connectivity are affected by acquired anemia. The investigators will perform baseline MRI monitoring for all subjects. All eligible subjects will be asked to provide informed consent before participating in the study. Comprehensive cerebrovascular MRI, baseline bloodwork, and neurocognitive testing will be collected from all subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '60 Years', 'minimumAge': '16 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Anemic subjects from Blood Donor Centers across Los Angeles will be recruited, the abnormal Menstrual Bleeding Clinic at Children's Hospital Los Angeles, and from the community if anemia can be documented.", 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria (observational component):\n\n* Age between 16 and 60 years of age.\n* Any ethnicity.\n* Either sex.\n* Anemic group: hemoglobin less than 10.5 g/dl on screening hemoglobin.\n* Control group: hemoglobin \\>13.2 g/dl for females, \\>14.6 g/dl for males, comparable age, sex and ethnicity to currently enrolled anemic subjects.\n\nExclusion criteria (observational component):\n\n* Diabetes requiring medication.\n* Hypertension requiring medication.\n* Sleep disordered breathing requiring intervention.\n* Body mass index \\>35 (morbid obesity)\n* Contraindications to MRI, including pacemaker, severe claustrophobia, pregnancy.\n* Known systemic inflammatory disease such as inflammatory bowel disease, systemic lupus erythematosus, or scleroderma.\n* Known HIV.\n\nInclusion criteria (interventional component):\n\n* Criteria for observational component, plus\n* ron deficiency anemia based upon attending hematologist interpretation of transferrin saturation, ferritin, and other ancillary labs including hs-CRP, MMA.\n\nExclusion criteria (interventional component):\n\n* Criteria for observational component, plus\n* Prior reaction to intravenous iron.\n* History of multiple drug allergies.\n* History of severe asthma, eczema, or atopy.\n* Systemic mastocytosis.\n* Severe respiratory or cardiac disease.'}, 'identificationModule': {'nctId': 'NCT04320966', 'briefTitle': 'Neurovascular Complications and White Matter Damage in Acquired Anemias', 'organization': {'class': 'OTHER', 'fullName': "Children's Hospital Los Angeles"}, 'officialTitle': 'Neurovascular Complications and White Matter Damage in Acquired Anemias', 'orgStudyIdInfo': {'id': 'CHLA-20-00037'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Acquired Anemia', 'description': 'Otherwise healthy individuals with hemoglobin below 10.5 g/dl or hematocrit below 32'}, {'label': 'Control', 'description': 'Age and sex matched individuals with hemoglobin in the upper quartile of normal'}]}, 'contactsLocationsModule': {'locations': [{'zip': '91010', 'city': 'Duarte', 'state': 'California', 'country': 'United States', 'facility': 'City of Hope Blood Donor Center', 'geoPoint': {'lat': 34.13945, 'lon': -117.97729}}, {'zip': '90027-6062', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Cedar Sinai Blood Bank', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90027', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': "Children's Hospital Los Angeles", 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of California, Los Angeles Blood Donor Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'overallOfficials': [{'name': 'John Wood, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Hospital Los Angeles"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Hospital Los Angeles", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'John C. Wood', 'investigatorAffiliation': "Children's Hospital Los Angeles"}}}}