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Prophylactic Transfusion In Pregnant in Women With Sickle Cell Disease

Study acronym: ProTIP
StatusRecruiting
PhasePhase 4
Started2026-04
View on ClinicalTrials.gov ↗

Amendment history

2026-02-16
notable
Not Yet Recruiting→Recruiting Study Identification, Study Status, Contacts/Locations v3
Trial statusNot Yet Recruiting→Recruiting
Start date2025-12→2026-04
Study sitesdetails revised at 1 of 1 site
2025-10-20
minor
Study Status v2
Start date2025-08→2025-12
2025-07-25
minor
Study Status, Outcome Measures v1
Start date2025-06→2025-08
Secondary endpoints11 entries, revised
NeonatalNumber of neonatal intensive care unit/critical care admissionadmissions
Primary endpoints5 entries, revised
Number of SCD-related complications per group
2025-05-13
minor
Original filing
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).
Trial Details
NCT Number NCT06979492
Lead Sponsor Emory University
Conditions Sickle Cell Disease, Pregnancy Related
Enrollment 50 participants
Start Date 2026-04
Primary Completion 2028-05 (estimated)
Study Completion 2028-05 (estimated)
Updated on ClinicalTrials.gov 2026-02-18