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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
Results First Posted : January 25, 2019
Last Update Posted : January 25, 2019
Sponsor:
Information provided by (Responsible Party):
Duke University

Tracking Information
First Submitted Date  ICMJE April 2, 2016
First Posted Date  ICMJE April 7, 2016
Results First Submitted Date  ICMJE November 9, 2018
Results First Posted Date  ICMJE January 25, 2019
Last Update Posted Date January 25, 2019
Actual Study Start Date  ICMJE December 2016
Actual Primary Completion Date December 31, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 31, 2018)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: April 6, 2016)
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 %.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 31, 2018)
  • Actual HbA Decrement (g/dl) With Indexing to Calculated Circulating Blood Volume [ Time Frame: 6 months ]
  • Actual HbA Decrement (g/dl) Without Indexing to Calculated Circulating Blood Volume [ Time Frame: 6 months ]
  • Change in RBC Microparticles (MP) Counts [ Time Frame: 6 months ]
  • Change in RBC/RBC-MP-mediated Thrombin Generation [ Time Frame: 6 months ]
  • Change in p50 Pre- and Post-transfusion [ Time Frame: 6 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: April 6, 2016)
  • 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) ]
  • 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) ]
  • Change in RBC Microparticles (MP) Counts [ Time Frame: At the time of each transfusion (approximately monthly for 6 months) ]
  • Change in RBC/RBC-MP-mediated Thrombin Generation [ Time Frame: At the time of each transfusion (approximately monthly for 6 months) ]
  • Change in p50 Pre- and Post-transfusion [ Time Frame: At the time of each transfusion (approximately monthly for 6 months) ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Rejuvesol® Washed RBC in Sickle Cell Patients Requiring Frequent Transfusions
Official Title  ICMJE Rejuvesol® Washed RBC in Sickle Cell Patients Requiring Frequent Transfusions
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.

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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Other
Condition  ICMJE Sickle Cell Disease
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Experimental: Transfusion with rejuvenated red blood cells (RBCs)
    Subjects with sickle cell disease will receive RBCs treated with Rejuvesol®. Scheduled red cell exchanges performed with the last 4 units of the exchange having been incubated with Rejuvesol® solution. Only transfusions necessary for the treatment of the sickle cell disease will be given for the purpose of the study.
    Interventions:
    • Drug: Rejuvesol
    • Procedure: Blood transfusion
  • 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.
    Intervention: Procedure: Blood transfusion
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 6, 2016)
4
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 31, 2017
Actual Primary Completion Date December 31, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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%.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02731157
Other Study ID Numbers  ICMJE Pro00069955
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Duke University
Study Sponsor  ICMJE Duke University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ian J Welsby, BSc MBBS Duke University
Principal Investigator: Jay Raval, MD University of North Carolina
PRS Account Duke University
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP