Neurovascular Complications and White Matter Damage in Acquired Anemias

Withdrawn

• Conditions: Healthy Controls; Anemia; Iron-deficiency Anemia

• Registration Number: NCT04320966
• Lead Sponsor: Children's Hospital Los Angeles

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.

Study Timeline

• Study First Submitted: 2020-03-16
• Study First Submitted QC: 2020-03-23
• Study First Posted: 2020-03-25
• Study Start: 2020-11-01
• Primary Completion: 2020-11-01
• Study Completion: 2020-11-01
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-27
• Last Update Posted: 2023-10-31

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Impact of acquired anemia on cerebrovascular oxygen delivery (ml O2/100g/min)	Day 0	Impact 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 0	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
Impact of acquired anemia on total brain blood flow (ml blood/100g/min)	Day 0	Phase contrast MRI will be assessed to determine whether acquired anemia affects total brain blood flow
Impact of acquired anemia on blood brain barrier permeability surface area product (ml H20/100g/min)	Day 0	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
Impact of acquired anemia on cerebral metabolic rate of oxygen (ml O2/100g/min)	Day 0	T2 relaxation under spin tagging (TRUST) acquisition via MRI will be used to assess any impact of anemia on cerebral metabolic rate of oxygen.

Trial Locations

Locations (4)

Cedar Sinai Blood Bank; 🇺🇸 Los Angeles, California, United States

City of Hope Blood Donor Center; 🇺🇸 Duarte, California, United States

University of California, Los Angeles Blood Donor Center; 🇺🇸 Los Angeles, California, United States

Children's Hospital Los Angeles; 🇺🇸 Los Angeles, California, United States