Status:
NOT_YET_RECRUITING
Prophylactic Transfusion In Pregnant in Women With Sickle Cell Disease
Lead Sponsor:
Emory University
Conditions:
Sickle Cell Disease
Pregnancy Related
Eligibility:
FEMALE
18+ years
Phase:
PHASE4
Brief 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 ...
Detailed Description
Sickle cell disease (SCD) is a common genetic disorder that results from the homozygous presence of abnormal β-globin chains (hemoglobin Hb SS, Hb SC, HbSβ thalassemia). SCD causes red blood cells to ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- Currently on chronic transfusion therapy before pregnancy
- Prior history of DHTR with hyperhemolysis
- Red cell antibody history, which would prevent the provision of adequate red cell units to support chronic transfusions.
- Unable or unwilling to receive blood transfusion for social, religious, or clinical reasons
- Known current triplet pregnancy
- Current diagnosis of major medical or psychiatric comorbidity, which in the randomizing clinician's opinion renders them unable to enter a clinical trial.
Key Trial Info
Start Date :
December 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2028
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06979492
Start Date
December 1 2025
End Date
May 1 2028
Last Update
October 22 2025
Active Locations (1)
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1
Grady Health System
Atlanta, Georgia, United States, 30303