Neurovascular Complications and White Matter Damage in Acquired Anemias

Last updated: October 27, 2023
Sponsor: Children's Hospital Los Angeles
Overall Status: Trial Not Available

Phase

N/A

Condition

Anemia

Healthy Volunteers

Treatment

N/A

Clinical Study ID

NCT04320966
CHLA-20-00037
  • Ages 16-60
  • All Genders
  • Accepts Healthy Volunteers

Study 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 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.

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.

Study Design

Study Start date:
November 01, 2020
Estimated Completion Date:
November 01, 2020

Study 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 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.

Connect with a study center

  • City of Hope Blood Donor Center

    Duarte, California 91010
    United States

    Site Not Available

  • Cedar Sinai Blood Bank

    Los Angeles, California 90027-6062
    United States

    Site Not Available

  • Children's Hospital Los Angeles

    Los Angeles, California 90027
    United States

    Site Not Available

  • University of California, Los Angeles Blood Donor Center

    Los Angeles, California 90095
    United States

    Site Not Available

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