Neurovascular Complications and White Matter Damage in Acquired Anemias

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2020-11-01

Study Completion Date

2020-11-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Anemia Iron-deficiency Anemia Healthy Controls

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Acquired Anemia

Otherwise healthy individuals with hemoglobin below 10.5 g/dl or hematocrit below 32

No interventions assigned to this group

Control

Age and sex matched individuals with hemoglobin in the upper quartile of normal

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 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.

* 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

* 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.

* 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.

Minimum Eligible Age

16 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes