Status:
WITHDRAWN
Neurovascular Complications and White Matter Damage in Acquired Anemias
Lead Sponsor:
Children's Hospital Los Angeles
Conditions:
Anemia
Iron-deficiency Anemia
Eligibility:
All Genders
16-60 years
Brief Summary
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 rese...
Detailed Description
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 rese...
Eligibility Criteria
Inclusion
- Inclusion criteria (observational component):
- Age between 16 and 60 years of age.
- Any ethnicity.
- Either sex.
- Anemic group: hemoglobin less than 10.5 g/dl on screening hemoglobin.
- 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.
- Exclusion criteria (observational component):
- Diabetes requiring medication.
- Hypertension requiring medication.
- Sleep disordered breathing requiring intervention.
- Body mass index \>35 (morbid obesity)
- Contraindications to MRI, including pacemaker, severe claustrophobia, pregnancy.
- Known systemic inflammatory disease such as inflammatory bowel disease, systemic lupus erythematosus, or scleroderma.
- Known HIV.
- Inclusion criteria (interventional component):
- Criteria for observational component, plus
- ron deficiency anemia based upon attending hematologist interpretation of transferrin saturation, ferritin, and other ancillary labs including hs-CRP, MMA.
- Exclusion criteria (interventional component):
- Criteria for observational component, plus
- Prior reaction to intravenous iron.
- History of multiple drug allergies.
- History of severe asthma, eczema, or atopy.
- Systemic mastocytosis.
- Severe respiratory or cardiac disease.
Exclusion
Key Trial Info
Start Date :
November 1 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 1 2020
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04320966
Start Date
November 1 2020
End Date
November 1 2020
Last Update
October 31 2023
Active Locations (4)
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1
City of Hope Blood Donor Center
Duarte, California, United States, 91010
2
Cedar Sinai Blood Bank
Los Angeles, California, United States, 90027-6062
3
Children's Hospital Los Angeles
Los Angeles, California, United States, 90027
4
University of California, Los Angeles Blood Donor Center
Los Angeles, California, United States, 90095