Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04426591 · ClinicalTrials.gov registry record · Phase 1
Red Blood Cell Survival in Sickle Cell Disease
A Phase 1 study of Sickle Cell Disease, sponsored by Marianne Yee.
- Completed
- Registry status
- Phase 1
- Development phase
- 22
- Enrollment target
- 3
- Study locations
NCT04426591: Completed Phase 1 study of Sickle Cell Disease, sponsored by Marianne Yee.
NCT04426591 is a Phase 1 study of Sickle Cell Disease that has completed, run by Marianne Yee. The registered enrollment target is 22 participants, below the 293-participant average among 213 other Sickle Cell Disease trials with a reported enrollment target (92% lower). The trial reports 3 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04426591, a Phase 1 study of Sickle Cell Disease, has completed, sponsored by Marianne Yee.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 22 participants
- Enrollment target
- 3
- Study locations
Study Summary
This is a single-arm, mechanistic clinical trial to measure predictors of senescence and the in vivo survival of transfused red blood cells (RBCs) in individuals with sickle cell disease (SCD) receiving chronic transfusion therapy (CTT). Chronic transfusion in patients with SCD is a common treatment. The efficacy of RBC transfusion therapy to treat or prevent complications of SCD may be hampered by variable survival of the transfused donor RBC. The overall aim is to see how long RBC survive in SCD patients who are chronically transfused. When a study participant has a regular blood transfusion the researchers will label a small portion of the RBCs that are transfused with biotin. The participant will return at Day 1, weekly for 3 months and monthly for 3 months to measure how long those RBCs survive. An optional sub-study using INTERCEPT RBCs will mirror the main study but will use INTERCEPT RBCs that have biotinylated for 1 RBC unit.
Primary Outcome
Survival of the transfused biotin-labeled RBCs (B-RBCs) at each time point was expressed as a ratio (percentage) compared to the initial 15-minute-post-transfusion B-RBC concentration. From measurements obtained from 24-hours through week 12 post-transfusion, survival was plotted over time, and recovery measurements were extrapolated.
Conditions Studied
Interventions
- DRUG Biotin Labeled Red Blood Cells
- DEVICE INTERCEPT Blood System
Study Locations (3)
Georgia
- Hughes Spalding Children's Hospital - Atlanta
- Childrens Healthcare of Atlanta - Atlanta
- Grady Health System - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2021-10-29 |
| Est. Completion | 2025-04-30 |
| Phase | Phase 1 |
What the finished NCT04426591 record still lists
NCT04426591 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 293-participant average among 213 other Sickle Cell Disease trials with a reported enrollment target (92% lower).
The record links to 1 condition, with Sickle Cell Disease appearing as the primary indexed condition, and to 2 interventions - of which Biotin Labeled Red Blood Cells is the first listed.
NCT04426591 reports a single indexed study location in Georgia.
Frequently Asked Questions
What is clinical trial NCT04426591 about?
NCT04426591 is a clinical study titled "Red Blood Cell Survival in Sickle Cell Disease". This is a single-arm, mechanistic clinical trial to measure predictors of senescence and the in vivo survival of transfused red blood cells (RBCs) in individuals with sickle cell disease (SCD) receiving chronic transfusion therapy (CTT). Chronic transfusion in patients with SCD is a common treatment...
What is the current status of trial NCT04426591?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 22 participants. The study started on 2021-10-29. Estimated completion is 2025-04-30.
What conditions does trial NCT04426591 study?
This clinical trial studies the following conditions: Sickle Cell Disease.
What interventions are being tested in trial NCT04426591?
The interventions under investigation include: Biotin Labeled Red Blood Cells (DRUG), INTERCEPT Blood System (DEVICE).
Who is sponsoring clinical trial NCT04426591?
This trial is sponsored by Marianne Yee, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04426591 being conducted?
This trial has 3 study locations across Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Sickle Cell Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04426591's enrollment target sits among peer trials
22 166th of 213 higher than 46 of 213 other Sickle Cell Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Sickle Cell Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Study of Panobinostat (LBH589) in Patients With Sickle Cell Disease
RECRUITING · Phase 1
-
Hematopoietic Stem Cell BCL11A Enhancer Gene Editing for Severe β-Hemoglobinopathies
RECRUITING · Phase 1
-
Gene Correction in Autologous CD34+ Hematopoietic Stem Cells (HbS to HbA) to Treat Severe Sickle Cell Disease
RECRUITING · Phase 1
-
PET Imaging of Vaso-Occlusive Crisis (VOC) in SCD
RECRUITING · Phase 1
-
Study to Evaluate the Safety and Tolerability of Escalating Doses of Fostamatinib in Subjects With Stable Sickle Cell Disease
RECRUITING · Phase 1
-
Methylphenidate to Address Attention and Executive Deficits Among Children With Sickle Cell Disease
RECRUITING · Phase 1
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02508038 · 22 participants · Phase 1
Alpha/Beta CD19+ Depleted Haploidentical Transplantation + Zometa for Pediatric Hematologic Malignancies and Solid Tumors
- NCT03099356 · 22 participants · Phase 2
Cyclophosphamide and Sirolimus for the Treatment of Metastatic, RAI-refractory, Differentiated Thyroid Cancer
- NCT03676647 · 22 participants
Diagnostic DNA Methylation Signature in Diagnosing Thyroid Cancer After Fine-Needle Aspiration in Patients With Thyroid Nodules
- NCT04569591 · 22 participants · NA
DDAVP for Pituitary Adenoma
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI