Hemolytic Anemia Clinical Trials

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Prophylactic Transfusion In Pregnant in Women With Sickle Cell Disease

Status: Recruiting
Location: See location...
Intervention Type: Biological, Other
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

The goal of this study is to determine if there is a positive effect of prophylactic red blood cell (RBC) transfusion of leukoreduced, ABO, Rh (D/Cc/Ee) and Kell matched blood compared to standard of care on the number of episodes of acute sickle cell disease (SCD) manifestations or pregnancy-related complications requiring acute health care encounters (acute care/ER/Hospital visits) or resulting in death over the entirety of pregnancy until 2 months post-partum in women with SCD. RBC transfusion is the only disease-modifying therapy for pregnant women with SCD, and it is considered a standard treatment option however, there exists no consensus on the role of transfusion therapy in preventing SCD-related pregnancy complications. Participants will be randomly assigned to repeated red blood cell transfusions or the standard of care. Participants will be on study for about 8-10 months (Pregnancy through 2 months post-partum).

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: t
View:

• Female

• Diagnosis of SCD of any genotype (i.e., HbSS, HbSC, HbSβ thalassemia)

• 18 Years and older

• Currently pregnant at 6 weeks through 20 weeks of gestation.

• Ability to understand the purposes and risks of the study and willingly give informed consent.

• For participants with private health insurance, insurance pre-approval for blood transfusions

Locations
United States
Georgia
Grady Health System
RECRUITING
Atlanta
Contact Information
Primary
Ross Fasano, MD
rfasano@emory.edu
404-712-5227
Time Frame
Start Date: 2026-04
Estimated Completion Date: 2028-05
Participants
Target number of participants: 50
Treatments
Other: Standard of Care
Patients randomized to the control group will receive standard care for SCD alone. As part of the standard of care, women with SCD who become pregnant and who are on hydroxyurea (HU) will have the HU suspended by their primary SCD provider.
Experimental: Red Blood Cell (RBC) Transfusion
Participants will receive a blood transfusion between 6 and 20 weeks of gestation. It will be repeated at 3-6 week intervals, aiming to maintain HbS \<30%
Sponsors
Leads: Emory University

This content was sourced from clinicaltrials.gov