Prophylactic Transfusion In Pregnant in Women With Sickle Cell Disease

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Emory University
Study ID
NCT06979492
Phase
PHASE4
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Prophylactic Transfusion Intervention group: Transfusion — BIOLOGICAL
    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.
  • Control group — OTHER
    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.

Study Details

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).

Key Dates

Start date
Apr 30, 2026
Status verified
Feb 2026
Primary completion
May 31, 2028
Completion
May 31, 2028

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • 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%

Primary Outcome Measure

Hospital admissions rate [ Time Frame: Baseline (enrollment) up to 8 weeks post-partum ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Grady Health SystemAtlantaGeorgia30303-

Find similar trials in Atlanta, GA

By condition
Sickle cell disease
By research site
Grady Health System· Atlanta, GA

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