Prophylactic Transfusion for Sickle Cell Disease in Pregnancy

(ProTIP Trial)

Overseen By Ross Fasano, MD

Age: 18+

Sex: Female

Trial Phase: Phase 4

Sponsor: Emory University

Disqualifiers: Chronic transfusion therapy, DHTR, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 8-10 months

50 Participants Needed

Trial Summary

What is the purpose of 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).

Research Team

Ross Fasano, MD

Principal Investigator

Emory University

Eligibility Criteria

This trial is for pregnant women with Sickle Cell Disease. It aims to see if regular blood transfusions during pregnancy and two months post-partum can reduce complications compared to standard care. Women must be expecting and diagnosed with SCD, but specific inclusion and exclusion criteria are not provided.

Inclusion Criteria

I understand the study's risks and agree to participate.

I am female.

I have been diagnosed with sickle cell disease.

Exclusion Criteria

Prior history of DHTR with hyperhemolysis

I was on regular blood transfusions before becoming pregnant.

Known current triplet pregnancy

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive repeated red blood cell transfusions or standard care from 6 to 20 weeks of gestation, repeated at 3-6 week intervals

8-10 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, including hospital admissions, emergency visits, and SCD-related complications

8 weeks post-partum

Treatment Details

Interventions

• Prophylactic Transfusion

Trial Overview The study tests whether prophylactic red blood cell transfusions can lower the risk of acute SCD episodes or pregnancy-related issues in women with SCD. Participants will either receive regular transfusions or standard care throughout their pregnancy until two months after giving birth.

Participant Groups

Group I: Standard of Care Experimental Treatment 1 Intervention

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.

Group II: Red Blood Cell (RBC) Transfusion Experimental Treatment 1 Intervention

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%

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials

1,735

Recruited

2,605,000+