AnemiaNCT04320966
Neurovascular Complications and White Matter Damage in Acquired Anemias
An observational study of Anemia and Iron-deficiency Anemia, run by Children's Hospital Los Angeles at 4 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 16 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Anemia, Iron-deficiency Anemia, Healthy Controls
- How many people
- 0 participants
- Where
- 4 sitesUnited States
- Study dates
- 1 Nov 2020to 1 Nov 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
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.
Who may be able to join
- 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.
- 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.
Who cannot join
- 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.
Show all 13Show fewer
- Known HIV.
- 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.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
City of Hope Blood Donor Center
Duarte, California, 91010
Cedar Sinai Blood Bank
Los Angeles, California, 90027-6062
Children's Hospital Los Angeles
Los Angeles, California, 90027
University of California, Los Angeles Blood Donor Center
Los Angeles, California, 90095
About this study
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.
Read the 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.
- Conditions
- Anemia, Iron-deficiency Anemia, Healthy Controls
- Medical subject headings
- Anemia, Anemia, Iron-Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2020
- Study start1 Nov 2020
- Primary completion1 Nov 2020
- Study completion1 Nov 2020
Why it stopped: Study was not funded.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnemiaStudies of the same condition, open and under way.
- More trials run by Children's Hospital Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John C. Wood, Children's Hospital Los Angeles
- Investigators
- John Wood, MD,PhD, Principal investigator, Children's Hospital Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04320966
- Sponsor's protocol ID
- CHLA-20-00037
- Status last verified
- Oct 2023
- First submitted
- 16 Mar 2020
- Last updated
- 31 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurovascular Complications and White Matter Damage in Acquired Anemias
- ClinicalTrials.gov ID
- NCT04320966
- Acronym / sponsor ID
- CHLA-20-00037
- Conditions
- Anemia, Iron-deficiency Anemia, Healthy Controls
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Study was not funded.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Children's Hospital Los AngelesUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 1 Nov 2020 (actual)
- Study completion
- 1 Nov 2020 (actual)
- First posted
- 25 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 16 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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
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
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.
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Wood, MD,PhD principal investigator
Children's Hospital Los Angeles
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anemia and Iron-deficiency Anemia, run by Children's Hospital Los Angeles at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 31 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact of acquired anemia on cerebrovascular oxygen delivery (ml O2/100g/min) (time frame: Day 0). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2023.