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Protocol Details

Red Cell Half Life Determination in Patients with and without Sickle Cell Disease

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

20-H-0080

Sponsoring Institute

National Heart, Lung and Blood Institute (NHLBI)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 18
Max Age: 99

Referral Letter Required

No

Population Exclusion(s)

Children

Special Instructions

Currently Not Provided

Keywords

Red Cell Survival;
Biotin;
Sickle Cell Anemia;
Sickle Cell Disease;
Sickle Cell Trait

Recruitment Keyword(s)

None

Condition(s)

Sickle Cell Disease;
Sickle Cell Anemia

Investigational Drug(s)

Biotin

Investigational Device(s)

None

Intervention(s)

Drug: Biotin label

Supporting Site

National Heart, Lung, and Blood Institute

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. In people with SCD, some RBCs are abnormal and die early. This leaves a shortage of healthy RBCs. Researchers want to learn more about how long RBCs live in the human body.

Objective:

To study how long RBCs live in people with and without SCD.

Eligibility:

People age 18 and older who either have SCD, had SCD but were cured with a bone marrow transplant, have the sickle cell trait (SCT), or are a healthy volunteer without SCD or SCT

Design:

Participants will be screened with a medical history and physical exam. They will give a blood sample.

Participants will have a small amount of blood drawn from a vein. In the laboratory, the blood will be mixed with a vitamin called biotin. Biotin sticks to the outside of RBCs without changing their function, shape, or overall lifetime. This process is known as biotin labeling of RBCs. The biotin labeled RBCs will be returned to the participant via vein injection.

Participants will give frequent blood samples. Their RBCs will be studied to see how many biotin labeled RBCs remain over time. This shows how long the RBCs live. Participants will give blood samples until no biotin labeled RBCs can be detected.

During the study visits, participants will report any major changes to their health.

Participation lasts for up to 6 months.

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Eligibility

INCLUSION CRITERIA:

- Age 18 or greater with a confirmed diagnosis of homozygous sickle cell anemia (HbSS), sickle cell trait (HbAS), or ethnic-matched healthy volunteer (HbA).

- Normal renal function: creatinine <1.5 mg/dL, proteinuria <1+.

- Negative direct antiglobulin test (DAT).

- Ability to give informed consent to participate in the protocol.

EXCLUSION CRITERIA:

- Any active chronic illness other than sickle cell disease.

- Blood transfusion within the preceding 90 days

- Active viral, bacterial, fungal, or parasitic infection.

-Consumption of biotin supplements or raw eggs within 30 days.

- Blood loss within the previous 8 weeks >30mL including but not limited by blood donation, trauma, gastrointestinal bleeding.

- Pregnancy

- Pre-existing, naturally occurring antibodies against biotin


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

John F. Tisdale, M.D.
National Heart, Lung and Blood Institute (NHLBI)



Wynona Coles
National Heart, Lung and Blood Institute (NHLBI)
National Institutes of Health
Building 10
Room 4-5350
10 Center Drive
Bethesda, Maryland 20892
(301) 402-2104
wcoles@nhlbi.nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: 1-866-411-1010
PRPL@cc.nih.gov

Clinical Trials Number:

NCT04476277

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