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Rejuvesol® Washed RBC in Sickle Cell Patients Requiring Frequent Transfusions

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ClinicalTrials.gov Identifier: NCT02731157
Recruitment Status : Completed
First Posted : April 7, 2016
Last Update Posted : June 13, 2018
Sponsor:
Information provided by (Responsible Party):
Duke University

Brief 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.


Condition or disease Intervention/treatment Phase
Sickle Cell Disease Drug: Rejuvesol Procedure: Blood transfusion Phase 4

Detailed 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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Other
Official Title: Rejuvesol® Washed RBC in Sickle Cell Patients Requiring Frequent Transfusions
Actual Study Start Date : December 2016
Actual Primary Completion Date : December 31, 2017
Actual Study Completion Date : December 31, 2017


Arm Intervention/treatment
Experimental: Transfusion with rejuveniated red blood cells (RBCs)
Subjects with sickle cell disease will receive RBCs treated with Rejuvesol. Only transfusions necessary for the treatment of the sickle cell disease will be given for the purpose of the study.
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.

Active Comparator: Transfusion with standard red blood cells
Subjects with sickle cell disease will receive standard RBCs. Only transfusions necessary for the treatment of the sickle cell disease will be given for the purpose of the study.
Procedure: Blood transfusion
Only transfusions necessary for the treatment of the sickle cell disease will be given for the purpose of the study.




Primary Outcome Measures :
  1. Percent hemoglobin (HbA) decrement [ Time Frame: At the time of each transfusion (approximately monthly for 6 months) ]
    The %HbA decrement is the current pre-treatment HbA - previous post treatment HbA in %.


Secondary Outcome Measures :
  1. Actual HbA decrement (g/dl) with indexing to calculated circulating blood volume [ Time Frame: At the time of each transfusion (approximately monthly for 6 months) ]
  2. Actual HbA decrement (g/dl) without indexing to calculated circulating blood volume [ Time Frame: At the time of each transfusion (approximately monthly for 6 months) ]
  3. Change in RBC microparticles (MP) counts [ Time Frame: At the time of each transfusion (approximately monthly for 6 months) ]
  4. Change in RBC/RBC-MP-mediated thrombin generation [ Time Frame: At the time of each transfusion (approximately monthly for 6 months) ]
  5. Change in p50 pre- and post-transfusion [ Time Frame: At the time of each transfusion (approximately monthly for 6 months) ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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%.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02731157


Locations
United States, North Carolina
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Duke Univeristy Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: Ian J Welsby, BSc MBBS Duke University
Principal Investigator: Jay Raval, MD University of North Carolina

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02731157     History of Changes
Other Study ID Numbers: Pro00069955
First Posted: April 7, 2016    Key Record Dates
Last Update Posted: June 13, 2018
Last Verified: June 2018

Additional relevant MeSH terms:
Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn