Kinetics of Donor Red Blood Cell Survival in Sickle Cell Disease

Study point of contact

Marianne Yee, MD
404-785-6190
[email protected]

Locations

3 United States sites

Age

> 6 Years

Genotypes

HbSS

Phase

Phase 1

Study type

Interventional

Gender

All

Interventions

Drug

Compensation

Unknown

About the study

This is a single-arm, mechanistic clinical trial to measure predictors of senescence and the
in vivo survival of transfused red blood cells (RBCs) in individuals with sickle cell disease
(SCD) receiving chronic transfusion therapy (CTT). Chronic transfusion in patients with SCD
is a common treatment. The efficacy of RBC transfusion therapy to treat or prevent
complications of SCD may be hampered by variable survival of the transfused donor RBC. The
overall aim is to see how long RBC survive in SCD patients who are chronically transfused.
When a study participant has a regular blood transfusion the researchers will label a small
portion of the RBCs that are transfused with biotin. The participant will return at Day 1,
weekly for 3 months and monthly for 3 months to measure how long those RBCs survive.

participation requirements

– HbSS or HbSβ0 thalassemia SCD

– receiving CTT for ≥3 months prior to enrollment

participation restrictions

– anticipated cessation of CTT in the next ≤2 months

– concurrent hydroxyurea therapy

– automated RBC exchange therapy within 3 months prior to enrollment or anticipated
within the next 3 months

– delayed hemolytic transfusion reaction in the past 3 months

– consuming high-dose biotin or raw egg supplements

– current pregnancy

Locations

  • Atlanta, Georgia, United States, Hughes Spalding Children's Hospital, 30303 [Recruiting]
  • Atlanta, Georgia, United States, Childrens Healthcare of Atlanta, 30322 [Recruiting]
  • Atlanta, Georgia, United States, Grady Health System, 30322 [Recruiting]
Last updated 2021-05-04 Enroll Now