Prophylactic Transfusion In Pregnant in Women With Sickle Cell Disease

NCT06979492 | Recruiting Phase 4 DMC FDA Drug

• 2 other identifiers: STUDY000072882025P013305
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Pregnancy Related; Sickle Cell Disease

Keywords

Blood transfusion; Anemia

Outcome Measures

Primary Outcomes (5)

• Hospital admissions rate

  Number of participants who require hospital admission during study participation divided by the total number of participants. Collected from medical records

  Baseline (enrollment) up to 8 weeks post-partum

• Number of maternal emergency department (ED)/Acute care visits

  Collected from medical records

  Baseline (enrollment) up to 8 weeks post-partum

• Number of SCD-related complications per group

  Sickle cell complications (vaso-occlusive crisis (VOC) / acute chest syndrome (ACS) / cerebral stroke) collected from medical records

  Baseline (enrollment) up to 8 weeks post-partum

• Number of participants with pregnancy related complications

  Number of participants who will develop pregnancy-related complications (pre-eclampsia, venous thromboembolism, infection). Collected from medical records

  Baseline (enrollment) up to 8 weeks post-partum

• Maternal death

  Number of women who die at any gestational age during pregnancy or within 8 weeks after delivery from any cause arising from the pregnancy or its management, but not from incidental or accidental causes, divided by the total number of participants.

  From randomization up to 8 weeks post-partum

Secondary Outcomes (11)

• Adult Sickle Cell Quality of Life Measurement System (ASCQ-Me)

  2, 4, 6, 8 and 10 months post randomization.

• Patient reported outcomes measurement information system (PROMIS)

  2, 4, 6, 8 and 10 months post randomization.

• Infant birth weight

  At delivery up to 42 weeks of pregnancy

• Preterm delivery

  Up to delivery (36 weeks of pregnancy)

• APGAR Scores

  1 and 5 minutes after neonate's delivery

Study Arms (2)

Standard of Care

OTHER

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.

Other: Control group

Red Blood Cell (RBC) Transfusion

EXPERIMENTAL

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%

Biological: Prophylactic Transfusion Intervention group: Transfusion

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.

Red Blood Cell (RBC) Transfusion

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.

Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: This study aims to determine the optimal management of pregnant women with SCD. Researchers will only include the following special population: Pregnant women.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female
• Diagnosis of SCD of any genotype (i.e., HbSS, HbSC, HbSβ thalassemia)
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Emory University: lead

Study Sites (1)

Grady Health System

Atlanta, Georgia, 30303, United States

RECRUITING

MeSH Terms

Conditions

Anemia, Sickle Cell; Anemia

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Ross Fasano, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ross Fasano, MD

CONTACT

404-712-5227; rfasano@emory.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 13, 2025
• First Posted: May 20, 2025
• Study Start: April 1, 2026
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2028
• Last Updated: February 18, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)