Preventive matched red blood cell transfusions during pregnancy for women with sickle cell disease
Prophylactic Transfusion In Pregnant in Women With Sickle Cell Disease
This trial will test whether regular preventive red blood cell transfusions during pregnancy reduce sickle cell–related complications and pregnancy-related hospital visits for women with sickle cell disease.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Emory University Academic / other |
| Locations | 1 site (Atlanta, Georgia) |
| Trial ID | NCT06979492 on ClinicalTrials.gov |
What this trial studies
Pregnant women with sickle cell disease are randomly assigned to receive repeated prophylactic leukoreduced, ABO/Rh (D/Cc/Ee) and Kell-matched red blood cell transfusions or to receive standard care without scheduled transfusions. The transfusion arm receives matched RBCs throughout pregnancy with follow-up until two months postpartum, for a total participation of about 8–10 months. The main outcome is the number of acute SCD manifestations or pregnancy-related complications that require emergency/acute care, hospitalization, or result in death during pregnancy through two months after delivery. Key exclusions include current chronic transfusion therapy, prior severe delayed hemolytic transfusion reaction with hyperhemolysis, or red cell antibodies that prevent providing compatible units.
Who should consider this trial
Good fit: Women aged 18 or older with any sickle cell genotype who are currently pregnant between 6 and 20 weeks gestation and not already on chronic transfusion therapy are ideal candidates.
Not a fit: Women already receiving chronic transfusions, those with prior severe transfusion reactions or incompatible red cell antibodies, or those unwilling/unable to receive transfusions are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, routine prophylactic transfusions could lower painful crises, acute complications like acute chest syndrome, and pregnancy-related hospital visits for pregnant women with SCD.
How similar studies have performed: Prophylactic transfusion has proven benefits for stroke prevention and preoperative care in SCD, but randomized evidence specifically supporting routine prophylactic transfusion during pregnancy is limited and not well established.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Atlanta, Georgia
- Grady Health System — Atlanta, Georgia, United States (Recruiting)
Study contacts
- Principal investigator: Ross Fasano, MD — Emory University
- Study coordinator: Ross Fasano, MD
- Email: rfasano@emory.edu
- Phone: 404-712-5227
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.