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Neurovascular Complications and White Matter Damage in Acquired Anemias

Neurovascular Complications and White Matter Damage in Acquired Anemias

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04320966
Enrollment
0
Registered
2020-03-25
Start date
2020-11-01
Completion date
2020-11-01
Last updated
2023-10-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anemia, Healthy Controls, Iron-deficiency Anemia

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 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.

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 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.

Interventions

None listed

Sponsors

Children's Hospital Los Angeles
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
16 Years to 60 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Impact of acquired anemia on cerebrovascular oxygen delivery (ml O2/100g/min)Day 0Impact of acquired anemia on cerebrovascular oxygen delivery will be assessed by measuring cerebral blood flow and oxygen content through MRI.
Impact of acquired anemia on cerebrovascular flow reactivity (%SI change/%ETCO2)Day 0baseline 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
Impact of acquired anemia on blood brain barrier permeability surface area product (ml H20/100g/min)Day 0baseline 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
Impact of acquired anemia on cerebral metabolic rate of oxygen (ml O2/100g/min)Day 0T2 relaxation under spin tagging (TRUST) acquisition via MRI will be used to assess any impact of anemia on cerebral metabolic rate of oxygen.
Impact of acquired anemia on total brain blood flow (ml blood/100g/min)Day 0Phase contrast MRI will be assessed to determine whether acquired anemia affects total brain blood flow

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026