Prophylactic Transfusion In Pregnant in Women With Sickle Cell Disease
About this study
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).
- Condition
- Sickle Cell Disease, Pregnancy Related
- Tested
- Prophylactic Transfusion Intervention group: Transfusion, Control group
- Sponsor
- Emory University
Who can join
- Age
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
Inclusion 9
- Minimum age: 18 years
- Eligible sex: Female
- Study condition: Sickle Cell Disease, Pregnancy Related
- 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 6
- 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.
Where
1 site, 1 recruiting
Grady Health System
Atlanta, Georgia, United States
Contact
-
Ross Fasano, MD
404-712-5227 rfasano@emory.edu
Potential match only. Final eligibility is determined by the study team.