Neurovascular Complications and White Matter Damage in Acquired Anemias

• Status: Not yet recruiting
• Trial end date: 2025-06-01
• Target enrollment: 130
• Participant gender: All

Summary

This is an observational trial, with an interventional arm, 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. We will perform baseline MRI monitoring for all subjects. Subjects with confirmed iron defiency will be offered intravenous iron therapy. Repeat MRI will be performed twice following iron replacement therapy. All eligible subjects will be asked to provide informed consent before participating in the study.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Children's Hospital Los Angeles
• Treatments: Ferric Compounds

Criteria

Inclusion criteria (observational component):

1. Age between 12 and 50 years of age.

2. Any ethnicity.

3. Either sex.

4. Anemic group: hemoglobin less than 11 g/dl on screening hemoglobin.

5. 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):

1. Diabetes requiring medication.

2. Hypertension requiring medication.

3. Sleep disordered breathing requiring intervention.

4. Body mass index >35 (morbid obesity)

5. Contraindications to MRI, including pacemaker, severe claustrophobia, pregnancy.

6. Known systemic inflammatory disease such as inflammatory bowel disease, systemic lupus erythematosus, or scleroderma.

7. Known HIV.

Inclusion criteria (interventional component):

1. Criteria for observational component, plus

2. Iron deficiency anemia based upon attending hematologist interpretation of transferrin saturation, ferritin, and other ancillary labs including hs-CRP, MMA.

Exclusion criteria (interventional component):

1. Criteria for observational component, plus

2. Prior reaction to intravenous iron.

3. History of multiple drug allergies.

4. History of severe asthma, eczema, or atopy.

5. Systemic mastocytosis.

6. Severe respiratory or cardiac disease.