- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04320966
Neurovascular Complications and White Matter Damage in Acquired Anemias
October 27, 2023 updated by: John C. Wood, Children's Hospital Los Angeles
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.
Study Overview
Status
Withdrawn
Conditions
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 Type
Observational
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Silvie Suriany, MSc
- Phone Number: (323) 361-4783
- Email: ssuriany@chla.usc.edu
Study Contact Backup
- Name: Candice Mulder, MPh, CCRP
- Phone Number: (323) 361-1646
- Email: cmulder@chla.usc.edu
Study Locations
-
-
California
-
Duarte, California, United States, 91010
- City of Hope Blood Donor Center
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Los Angeles, California, United States, 90027
- Children's Hospital Los Angeles
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Los Angeles, California, United States, 90027-6062
- Cedar Sinai Blood Bank
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Los Angeles, California, United States, 90095
- University of California, Los Angeles Blood Donor Center
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 60 years (Child, Adult)
Accepts Healthy Volunteers
Yes
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.
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Day 0
|
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
|
Day 0
|
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
|
Day 0
|
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.
|
Day 0
|
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
|
Day 0
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: John Wood, MD,PhD, Children's Hospital Los Angeles
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 1, 2020
Primary Completion (Actual)
November 1, 2020
Study Completion (Actual)
November 1, 2020
Study Registration Dates
First Submitted
March 16, 2020
First Submitted That Met QC Criteria
March 23, 2020
First Posted (Actual)
March 25, 2020
Study Record Updates
Last Update Posted (Actual)
October 31, 2023
Last Update Submitted That Met QC Criteria
October 27, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHLA-20-00037
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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