Status:
COMPLETED
Red Cell Half Life Determination in Patients With and Without Sickle Cell Disease
Lead Sponsor:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Sickle Cell Disease
Sickle Cell Anemia
Eligibility:
All Genders
18-99 years
Phase:
EARLY_PHASE1
Brief Summary
Background: Sickle cell disease (SCD) is an inherited blood disorder. It results from a single genetic change (mutation) in red blood cells (RBCs). RBCs are the cells that carry oxygen to the body. I...
Detailed Description
Study Description: This study will use biotin-labeling of red blood cells (RBCs) to determine the mean potential lifespan (MPL) of RBCs in patients with sickle cell disease (SCD) compared to patients...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Age 18 or greater with a confirmed diagnosis of homozygous SCD (HbSS, HbSC, HbSB0), sickle cell trait (HbAS), or healthy volunteer (HbA)
- Normal renal function: creatinine \<1.5 mg/dL
- Negative direct antiglobulin test (DAT)
- Ability to give informed consent to participate in the protocol
- EXCLUSION CRITERIA:
- Any uncontrolled chronic illness other than sickle cell disease
- Active viral, bacterial, fungal, or parasitic infection
- Consumption of biotin supplements or raw eggs within 30 days
- Blood loss within the previous 8 weeks \>540mL
- Pregnancy
- Pre-existing, naturally occurring antibodies against biotin
Exclusion
Key Trial Info
Start Date :
April 19 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 14 2023
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT04476277
Start Date
April 19 2021
End Date
February 14 2023
Last Update
February 13 2024
Active Locations (1)
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1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892