CHLA Research Study on Neurovascular and Neurocognitive Consequences of Iron Deficiency Anemia
Objetivo
Anemia is a condition where the body is not making enough red blood cells to transport oxygen. The objective of this study is to learn about the impact of anemia on the oxygen delivery to the brain as measured by magnetic resonance imaging (MRI) and brain cognitive functions. We hope to better identify people who may benefit from correction of their anemia by exploring different effects of iron therapy.
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In order to be considered for this study, hemoglobin or hematocrit level needs to be measured. If you think you have anemia but do not have a recent record of your hemoglobin or hematocrit level, please request for a screening visit from us.
If you are between 18 and 60 years of age, and have a hemoglobin level of 10.5 or below, or hematocrit level below 32 if tested using finger prick or plethysmography, or hemoglobin <11 or hematocrit <33 if tested using a blood draw via venipuncture. You must have a record of recent test results, or be screened through us.
If you participate in this study, you will get thorough blood workup, brain MRI scan and neurocognitive test. If found eligible, you may receive iron therapy in either IV infusion or be referred to your doctor for oral iron. Participation in this study is voluntary.
Palabras clave: anemia, iron deficiency anemia, brain, low hemoglobin, mri, neurovascular, neurocognitive, low iron
Sitios de estudio
4650 sunset blvd 90027
- Women
¿Qué hay involucrado?
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Interventional arm: 13 months
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Observational arm: 1-3 visits if you need screening visit or 1-2 visits if you already have recent hemoglobin or hematocrit levels.
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Interventional arm (if applicable): 6 visits if you are receiving the intravenous iron infusion. 4 visits if you are receiving referral to your doctor
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ferric derisomaltose and novaferrum
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Brain MRI
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Blood draw
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Neurocognitive test
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Intravenous iron infusion (ferric derisomaltose)
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Novaferrum (iron pills)
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Compensation is available for completion of prescreening visit and study procedures.
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Study-related tests and procedures are covered; Routine health care tests and procedures are not covered; Research injury related costs are not covered. All study-related costs are covered by the research grant.
Elegibilidad
Criterios de inclusión
- Observational arm:
- • Must be between 18 and 60 years of age.
- • Female
- • Anemic group: hemoglobin ≤10.5 g/dl from plethysmography, or hematocrit of <32% from finger prick, or <11 g/dl from venipuncture (you must have a proof of recent test results, or be screened through us)
- • Control group: hemoglobin >13.2 g/dl or hematocrit >39.6%
- Interventional arm:
- • Having completed observational procedures
- • Criteria for observational component, plus
- • Iron deficiency anemia based upon attending hematologist interpretation of transferrin saturation, ferritin, and other ancillary labs including hs-CRP, MMA, hemoglobin electrophoresis
Criterios de exclusión
- Observational arm:
- • Diabetes requiring medication
- • Hypertension (systolic blood pressures persistently > 140 mmHg or diastolic blood pressures > 90 mmHg) requiring medication
- • Sleep disordered breathing requiring intervention
- • Contraindications to MRI, including pacemaker, severe claustrophobia or pregnancy or dental braces
- • Known systemic inflammatory disease such as inflammatory bowel disease, rheumatoid arthritis, systemic lupus erythematosus, or scleroderma
- • Known HIV
- • Body mass index >40 (morbid obesity)
- Interventional arm:
- • 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
- • Having no access to a physician who can manage the iron deficiency anemia.
Equipo del Programa
For questions about this study, contact:
- Research Specialist Silvie Suriany
- Children's Hospital Los Angeles
- 323-361-4783
- ssuriany@chla.usc.edu
Research study materials
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