NCT06979492 · Emory University
Prophylactic Transfusion In Pregnant in Women With Sickle Cell Disease
(ProTIP)
What this study is about
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 the usual treatment 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 the usual treatment. Participants will be on study for about 8-10 months (Pregnancy through 2 months post-partum).
View original scientific description
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).
Interventions
BIOLOGICAL
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.
OTHER
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 measures
Hospital admissions rate
Time frame: Baseline (enrollment) up to 8 weeks post-partum
Number of participants who require hospital admission during study participation divided by the total number of participants. Collected from medical records
Number of maternal emergency department (ED)/Acute care visits
Time frame: Baseline (enrollment) up to 8 weeks post-partum
Collected from medical records
Number of SCD-related complications per group
Time frame: Baseline (enrollment) up to 8 weeks post-partum
Sickle cell complications (vaso-occlusive crisis (VOC) / acute chest syndrome (ACS) / cerebral stroke) collected from medical records
Number of participants with pregnancy related complications
Time frame: Baseline (enrollment) up to 8 weeks post-partum
Number of participants who will develop pregnancy-related complications (pre-eclampsia, venous thromboembolism, infection). Collected from medical records
Maternal death
Time frame: From randomization up to 8 weeks post-partum
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
- Atlanta, Georgia
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 18, 2026 · Source of record for eligibility and locations