Neurovascular Complications and White Matter Damage in Acquired Anemias

NCT04320966 | Withdrawn

• 1 other identifier: CHLA-20-00037
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 4

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.

Conditions

Anemia; Iron-deficiency Anemia; Healthy Controls

Outcome Measures

Primary Outcomes (5)

• Impact of acquired anemia on cerebrovascular oxygen delivery (ml O2/100g/min)

  Impact of acquired anemia on cerebrovascular oxygen delivery will be assessed by measuring cerebral blood flow and oxygen content through MRI.

  Day 0

• Impact of acquired anemia on cerebrovascular flow reactivity (%SI change/%ETCO2)

  baseline 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

  Day 0

• Impact of acquired anemia on blood brain barrier permeability surface area product (ml H20/100g/min)

  baseline 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

  Day 0

• Impact of acquired anemia on cerebral metabolic rate of oxygen (ml O2/100g/min)

  T2 relaxation under spin tagging (TRUST) acquisition via MRI will be used to assess any impact of anemia on cerebral metabolic rate of oxygen.

  Day 0

• Impact of acquired anemia on total brain blood flow (ml blood/100g/min)

  Phase contrast MRI will be assessed to determine whether acquired anemia affects total brain blood flow

  Day 0

Study Arms (2)

Acquired Anemia

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

Control

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

Eligibility Criteria

• Age: 16 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Anemic subjects from Blood Donor Centers across Los Angeles will be recruited, the abnormal Menstrual Bleeding Clinic at Children's Hospital Los Angeles, and from the community if anemia can be documented.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Children's Hospital Los Angeles: lead

Study Sites (4)

City of Hope Blood Donor Center

Duarte, California, 91010, United States

Location

Cedar Sinai Blood Bank

Los Angeles, California, 90027-6062, United States

Location

Children's Hospital Los Angeles

Los Angeles, California, 90027, United States

Location

University of California, Los Angeles Blood Donor Center

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Anemia; Anemia, Iron-Deficiency

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Anemia, Hypochromic; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• John Wood, MD,PhD

  Children's Hospital Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 16, 2020
• First Posted: March 25, 2020
• Study Start: November 1, 2020
• Primary Completion: November 1, 2020
• Study Completion: November 1, 2020
• Last Updated: October 31, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)