RECRUITINGPhase 4INTERVENTIONAL

Prophylactic Transfusion In Pregnant in Women With Sickle Cell Disease

About This Trial

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).

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form. - For participants with private health insurance, insurance pre-approval for blood transfusions Who Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: * 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 Criteria: * 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.

Treatments Being Tested

BIOLOGICAL

Prophylactic Transfusion Intervention group: Transfusion

For participants randomized to the prophylactic transfusion intervention group, the first RBC transfusion will occur within 3 weeks of randomization. All transfusions will be managed per SOC. SOC prophylactic RBC transfusion management is as follows: transfusions are performed at 3-6 week intervals with the intent to maintain a pre-transfusion hemoglobin S level at \<30%. All participants will have a complete blood count, reticulocyte count, hemoglobin fractionation, complete metabolic profile with LDH, ferritin, and type/screen at baseline and within 3 days of all monthly transfusions. All RBC transfusions must be compatible between the recipient and the donor and antigen matched for Rh (D/Cc/Ee) and Kell antigens at a minimum. For participants with a previous history of RBC alloimmunization, extended matched RBCs will be provided (Rh, Kell, Duffy, Kidd, S/s) per NHLBI/ASH guidelines to minimize further alloimmunization.

OTHER

Control group

Participants randomized to the control group will be followed per SOC. SOC management for pregnant women with SCD includes but is not limited to * Clinic appointments with an SCD provider every 2 months * Lab draws - complete blood count, reticulocyte count, hemoglobin fractionation, complete metabolic profile with LDH and ferritin.

Locations (1)

Grady Health System

Atlanta, Georgia, United States