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Neurovascular Complications and White Matter Damage in Acquired Anemias

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ClinicalTrials.gov Identifier: NCT04320966
Recruitment Status : Recruiting
First Posted : March 25, 2020
Last Update Posted : May 11, 2021
Sponsor:
Information provided by (Responsible Party):
John C. Wood, 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. S All eligible subjects will be asked to provide informed consent before participating in the study.

Condition or disease
Anemia Iron-deficiency Anemia Healthy Controls

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.

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Study Type : Observational
Estimated Enrollment : 45 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Neurovascular Complications and White Matter Damage in Acquired Anemias
Actual Study Start Date : November 1, 2020
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : June 30, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia

Group/Cohort
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



Primary Outcome Measures :
  1. Impact of acquired anemia on cerebrovascular oxygen delivery (ml O2/100g/min) [ Time Frame: Day 0 ]
    Impact of acquired anemia on cerebrovascular oxygen delivery will be assessed by measuring cerebral blood flow and oxygen content through MRI.

  2. Impact of acquired anemia on cerebrovascular flow reactivity (%SI change/%ETCO2) [ Time Frame: 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

  3. Impact of acquired anemia on blood brain barrier permeability surface area product (ml H20/100g/min) [ Time Frame: 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

  4. Impact of acquired anemia on cerebral metabolic rate of oxygen (ml O2/100g/min) [ Time Frame: 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.

  5. Impact of acquired anemia on total brain blood flow (ml blood/100g/min) [ Time Frame: Day 0 ]
    Phase contrast MRI will be assessed to determine whether acquired anemia affects total brain blood flow



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Ages Eligible for Study:   16 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
We will recruit anemic subjects from Blood Donor Centers across Los Angeles as well as the abnormal Menstrual Bleeding Clinic at Children's hospital Los Angeles.
Criteria

Inclusion criteria (observational component):

  1. Age between 16 and 60 years of age.
  2. Any ethnicity.
  3. Either sex.
  4. Anemic group: hemoglobin less than 10.5 g/dl on screening hemoglobin.
  5. 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):

  1. Diabetes requiring medication.
  2. Hypertension requiring medication.
  3. Sleep disordered breathing requiring intervention.
  4. Body mass index >35 (morbid obesity)
  5. Contraindications to MRI, including pacemaker, severe claustrophobia, pregnancy.
  6. Known systemic inflammatory disease such as inflammatory bowel disease, systemic lupus erythematosus, or scleroderma.
  7. Known HIV.

Inclusion criteria (interventional component):

  1. Criteria for observational component, plus
  2. Iron deficiency anemia based upon attending hematologist interpretation of transferrin saturation, ferritin, and other ancillary labs including hs-CRP, MMA.

Exclusion criteria (interventional component):

  1. Criteria for observational component, plus
  2. Prior reaction to intravenous iron.
  3. History of multiple drug allergies.
  4. History of severe asthma, eczema, or atopy.
  5. Systemic mastocytosis.
  6. Severe respiratory or cardiac disease.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04320966


Contacts
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Contact: Silvie Suriany, MSc (323) 361-4783 ssuriany@chla.usc.edu
Contact: Candice Mulder, MPh, CCRP (323) 361-1646 cmulder@chla.usc.edu

Locations
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United States, California
City of Hope Blood Donor Center Not yet recruiting
Duarte, California, United States, 91010
Contact: Lefan Zhuang, MD       lzhuang@coh.org   
Contact: Silvie Suriany, BS    626 373 7353    ssuriany@chla.usc.edu   
Principal Investigator: Lefan Zhuang, MD         
Cedar Sinai Blood Bank Not yet recruiting
Los Angeles, California, United States, 90027-6062
Contact: Ellen Klapper, MD       Ellen.Klapper@cshs.org   
Contact: Silvie Suriany, BS    626 373 7353    ssuriany@chla.usc.edu   
Principal Investigator: Ellen Klapper, MD         
Children's Hospital Los Angeles Recruiting
Los Angeles, California, United States, 90027
Contact: Silvie Suriany, MSc    323-361-4783    ssuriany@chla.usc.edu   
Principal Investigator: John C Wood, MD, PhD         
University of California, Los Angeles Blood Donor Center Not yet recruiting
Los Angeles, California, United States, 90095
Contact: Dawn Ward, MD       DWard@mednet.ucla.edu   
Contact: Silvie Suriany, BS    626 373 7353    ssuriany@chla.usc.edu   
Principal Investigator: Dawn Ward, MD         
Sub-Investigator: Alyssa Ziman, MD         
Sponsors and Collaborators
Children's Hospital Los Angeles
Investigators
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Principal Investigator: John Wood, MD,PhD Children's Hospital Los Angeles
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Responsible Party: John C. Wood, Professor, Children's Hospital Los Angeles
ClinicalTrials.gov Identifier: NCT04320966    
Other Study ID Numbers: 20-00037
First Posted: March 25, 2020    Key Record Dates
Last Update Posted: May 11, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Anemia
Anemia, Iron-Deficiency
Hematologic Diseases
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases