Prophylactic Transfusion In Pregnant in Women With Sickle Cell Disease

PHASE4Not yet recruitingINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

December 31, 2025

Primary Completion Date

May 31, 2028

Study Completion Date

May 31, 2028

Conditions
Sickle Cell DiseasePregnancy Related
Interventions
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."

Trial Locations (1)

30303

Grady Health System, Atlanta

All Listed Sponsors
lead

Emory University

OTHER