Phase 4 Completed N=4 Single-blind Other

Rejuvesol® Washed RBC in Sickle Cell Patients Requiring Frequent Transfusions

Sickle Cell Disease

Source: ClinicalTrials.gov NCT02731157 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jan 2019

Primary outcomePrimary: Average Percent Hemoglobin (HbA) Decrement Per Day — 0.629; 0.659 %HbA per day — p=0.95

◆ Published Evidence

No publication linked

No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.

Summary

The objective of this proposal is to test the feasibility of red blood cell (RBC) rejuvenation to chronic transfusion in sickle cell disease (SCD) and the potential benefit of RBC rejuvenation in this population to determine if a larger clinical trial powered to definitively characterize the benefits of rejuvenation is warranted. This is a small pilot study is to see if restoring important energy molecules (ATP and 2,3,DPG) in stored red blood cells before they are transfused, with a rejuvenating solution (Rejuvesol), offers any advantages to individuals over standard blood transfusion. Subjects will receive either rejuvenated (R) or standard (S) RBCs with each transfusion for 6 transfusions (over approximately a 6-month period) in a pre-defined order to maximize detection of any signal.

Outcome Measures

Outcome	Result	p-value
PRIMARY Average Percent Hemoglobin (HbA) Decrement Per Day	0.629; 0.659	0.95
SECONDARY Actual HbA Decrement (g/dl) With Indexing to Calculated Circulating Blood Volume	—	—
SECONDARY Actual HbA Decrement (g/dl) Without Indexing to Calculated Circulating Blood Volume	—	—
SECONDARY Change in RBC Microparticles (MP) Counts	—	—
SECONDARY Change in RBC/RBC-MP-mediated Thrombin Generation	—	—
SECONDARY Change in p50 Pre- and Post-transfusion	—	—

Eligibility Criteria

Inclusion Criteria

Stable, compliant, chronically transfused sickle cell disease (SCD) patients
Currently maintained crisis-free with repeated RBC therapy for at least 3 consecutive sessions
≥18 years old
Have Hb SS disease
Have the capacity to give informed consent

Exclusion Criteria

Baseline need for washed RBCs
Pre-treatment SaO2 < 92%.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02731157). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.