Rejuvesol® Washed RBC in Sickle Cell Patients Requiring Frequent Transfusions

Sickle Cell Disease Clinical Trial

Official title:

Rejuvesol® Washed RBC in Sickle Cell Patients Requiring Frequent Transfusions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02731157
• Other study ID #: Pro00069955
• Status: Completed
• Phase: Phase 4
• Start date: December 2016
• Est. completion date: December 31, 2017

Study information

• Verified date: December 2018
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Blood transfusion is part of the standard care for individuals that have sickle cell disease. Often these transfusions become needed quite frequently. The purpose of the red blood cells in the blood is to deliver oxygen to the organs and tissues of the body. People with sickle cell disease have abnormal red blood cells. Stored blood undergoes some changes that may make it less effective in achieving this goal.

The purpose of this 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. This is a Food and Drug Administration (FDA) approved process that is described by the American Association of Blood Banks for prolonging blood storage but not used for everyday transfusions. The investigators want to use this process to improve blood transfused to individuals who need frequent transfusions. Potential advantages include better delivery of oxygen by the transfused red blood cells and easier release of oxygen to the tissues. In addition the study will assess how using the rejuvenated blood affects the interval between transfusions. This means possibly that transfusions may not be needed as often.

Although Rejuvesol has been previously approved by the FDA, it is not routinely used to prepare standard blood transfusions to individuals who have sickle cell disease. Use of Rejuvesol in this study is considered investigational.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: December 31, 2017
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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%.

Related Conditions & MeSH terms

• Anemia, Sickle Cell
• Sickle Cell Disease

Intervention

Drug:
• Rejuvesol

Procedure:
• Blood transfusion
Only transfusions necessary for the treatment of the sickle cell disease will be given for the purpose of the study.

Locations

Country	Name	City	State
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina
United States	Duke Univeristy Medical Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Average Percent Hemoglobin (HbA) Decrement Per Day	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.	6 months
Secondary	Actual HbA Decrement (g/dl) With Indexing to Calculated Circulating Blood Volume		6 months
Secondary	Actual HbA Decrement (g/dl) Without Indexing to Calculated Circulating Blood Volume		6 months
Secondary	Change in RBC Microparticles (MP) Counts		6 months
Secondary	Change in RBC/RBC-MP-mediated Thrombin Generation		6 months
Secondary	Change in p50 Pre- and Post-transfusion		6 months