Neurovascular Complications and White Matter Damage in Acquired Anemias

Anemia Clinical Trial

Official title:

Neurovascular Complications and White Matter Damage in Acquired Anemias

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04320966
• Other study ID #: CHLA-20-00037
• Status: Withdrawn
• Start date: November 1, 2020
• Est. completion date: November 1, 2020

Study information

• Verified date: October 2023
• Source: Children's Hospital Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 1, 2020
• Est. primary completion date: November 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anemia
• Anemia, Iron-Deficiency
• Healthy Controls
• Iron-deficiency Anemia

Locations

Country	Name	City	State
United States	City of Hope Blood Donor Center	Duarte	California
United States	Cedar Sinai Blood Bank	Los Angeles	California
United States	Children's Hospital Los Angeles	Los Angeles	California
United States	University of California, Los Angeles Blood Donor Center	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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