NCT02731157

Rejuvesol® Washed RBC in Sickle Cell Patients Requiring Frequent Transfusions

Completed Phase 4 Results posted Last updated 31 December 2018

What this trial tests

Phase 4 trial testing Rejuvesol in Sickle Cell Disease in 4 participants. Completed in 31 December 2017.

Timeline

1 December 2016

Primary endpoint
31 December 2017

31 December 2017

Quick facts

Lead sponsor	Duke University
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	crossover
Masking	single
Primary purpose	other
Enrollment	4
Start date	1 December 2016
Primary completion	31 December 2017
Estimated completion	31 December 2017
Sites	2 locations across United States

Drugs / interventions tested

• Rejuvesol — full drug profile →
• Blood transfusion — full drug profile →

Conditions studied

• Sickle Cell Disease — all drugs for Sickle Cell Disease →

Sponsor

Duke University

Who can join

18 and older, any sex, with Sickle Cell Disease. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Average Percent Hemoglobin (HbA) Decrement Per Day
  Time frame: 6 months
  The %HbA decrement is the current pre-treatment HbA - previous post treatment HbA in %. The average %HbA decrement per day was calculated using matched pairs.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Effects of red blood cell (RBC) transfusion on sickle cell disease recipient plasma and RBC metabolism.
   Culp-Hill R, Srinivasan AJ, Gehrke S, Kamyszek R, et al · · 2018 · cited 36× · PMID 30265764 · DOI 10.1111/trf.14931