Study of Methodologies to Measure Blood Flow and Oxygenation in Adults With Sickle Cell Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

38 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-06-30

Study Completion Date

2016-10-31

Brief Summary

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The purpose of the study is to determine whether imaging techniques, such as magnetic resonance imaging (MRI), near infrared spectroscopy (NIRS), laser speckle contrast imaging (LSCI), and optical imaging (OI), can detect differences in blood flow and oxygen levels in different organ systems of participants with sickle cell disease (SCD). Differences in blood flow and oxygen levels detected by these techniques will be evaluated to determine their utility as biomarkers of clinical disease pathophysiology.

Detailed Description

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Conditions

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Healthy Sickle Cell Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Part A

Cohort 1- Participants with severe SCD (4-10 VOC/year) Cohort 2- Participants with milder SCD (\<4-10 VOC/year) Cohort 3- Healthy volunteers Part A and B can occur in parallel

No interventions assigned to this group

Part B

Adults with SCD receiving chronic red blood cell exchange transfusion Part A and B can occur in parallel

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

1. Have a diagnosis of SCD confirmed by hemoglobin analysis.
2. Be in stable clinical condition, as determined by the Investigator.

Subjects enrolled in Part B must also meet the following eligibility criterion at Screening:
3. Receiving scheduled standard of care RBC exchange transfusion therapy, with ≥3 transfusions already received.
4. Be deemed healthy, as determined by the Investigator, based on the physical examination, medical history, vital signs, 12-lead electrocardiogram (ECG), and clinical laboratory measurements.

Exclusion Criteria

1. Inability to lie still for ≥5 minutes, claustrophobia sufficient to interfere with generating reliable MRI scans, body weight exceeding 320.0 lbs., or girth exceeding the magnet bore.
2. Presence of a metal device affected by MRI (e.g., any type of electronic, mechanical or magnetic implant, cardiac pacemaker, aneurysm clips, implanted cardiac defibrillator) or potential ferromagnetic foreign body (metal slivers, metal shavings, other metal objects) which would be a contraindication for MRI.
3. Acute pain crisis requiring hospitalization, with a discharge ≤4 weeks prior to the first imaging visit, or when determined by the Investigator to not be at steady state.
4. Recent (≤3 months) treatment with hydroxyurea therapy.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Bioverativ Therapeutics Inc.

Locations

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Research Site

Detroit, Michigan, United States

Site Status

Countries

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United States

Other Identifiers

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996SC001

Identifier Type: -

Identifier Source: org_study_id