Recruiting

RBC Transfusion

Sponsor:

Emory University

Code:

NCT06979492

Conditions

Sickle Cell Disease

Pregnancy Related

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Interventions

Prophylactic Transfusion Intervention group: Transfusion

Control group

Study Details

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 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).

Conditions

Sickle Cell Disease

Pregnancy Related

Study ID

NCT06979492

Start date

Apr, 2026

Status verified date

Feb, 2026

Completion date

May, 2028

Anticipated

Primary completion date

May, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

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%

Interventions

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.

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.

Primary outcome measure

  • Hospital admissions rate [ Time Frame: Baseline (enrollment) up to 8 weeks post-partum ]
  • Number of maternal emergency department (ED)/Acute care visits [ Time Frame: Baseline (enrollment) up to 8 weeks post-partum ]
  • Number of SCD-related complications per group [ Time Frame: Baseline (enrollment) up to 8 weeks post-partum ]
  • Number of participants with pregnancy related complications [ Time Frame: Baseline (enrollment) up to 8 weeks post-partum ]
  • Maternal death [ Time Frame: From randomization up to 8 weeks post-partum ]

Central Contacts and Locations

Central contacts

Ross Fasano, MD

404-712-5227rfasano@emory.edu

Locations

Grady Health System

Recruiting

Atlanta, Georgia, United States, 30303

More Information

Sponsor

Emory University

Last update posted

Feb 18, 2026

Last verified

Feb, 2026

Keywords

  • Blood transfusion
  • Anemia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Emory University on 2026-02-18.