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The Impact of Oxidative Stress on Erythrocyte Bilogy (RBC Survival)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04028700
Recruitment Status : Not yet recruiting
First Posted : July 23, 2019
Last Update Posted : July 23, 2019
Sponsor:
Collaborators:
Columbia University
Medical College of Wisconsin
Information provided by (Responsible Party):
Matthew Karafin, Versiti

Brief Summary:
This study will address if red blood cells transfused to a sickle cell patient from a donor with a G6DP enzyme deficiency have a different lifespan as measured by the percentage of red blood cells that survive post-transfusion compared to red blood cells transfused to a sickle cell patient from a donor without a G6DP enzyme deficiency.

Condition or disease Intervention/treatment Phase
Sickle Cell Disease Without Crisis Biological: Red Blood Cell Transfusion Phase 2

Detailed Description:
This prospective, phase II, crossover, single-blind, randomized transfusion order study will address if red blood cells from donors with a G6DP enzyme deficiency have a different lifespan once transfused into a patient with sickle cell disease than red blood cells from an otherwise normal donor. Results of this critical study will guide future research and donor testing policies to ensure that patients receive the most appropriate units of blood for their condition. Each patient randomized to the study will receive 2 blood transfusions, one from a G6DP deficient donor and one from an otherwise normal donor. Half the patients (8) will receive G6DP deficient blood first while the other half (8) will receive non-G6DP deficient blood first. Patients will have a wash-out period of at least 3 months before receiving the opposite type of blood transfusion. The blood transfusion order will be randomized. There is currently no standard of testing in place to screen blood donations for G6DP enzyme deficiency. It is believed that up to 10% of the antigen-matched donors for patients with sickle cell disease are G6DP deficient, and the lifespan is unknown in the sickle cell population.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Masking Description: Patients will not be told which type of blood they are receiving first. There is no way to tell if blood has enzyme deficiencies by looking at it.
Primary Purpose: Supportive Care
Official Title: Red Blood Cell Survival Study: The Impact of Oxidative Stress on Erythrocyte Bilogy
Estimated Study Start Date : October 1, 2019
Estimated Primary Completion Date : October 1, 2023
Estimated Study Completion Date : October 1, 2023


Arm Intervention/treatment
Experimental: G6DP Deficient Red Blood Cell Transfusion
Transfusion of red blood cells that have been identified by local laboratory procedures to be deficient in G6PD enzyme activity.
Biological: Red Blood Cell Transfusion
Patients will receive a red blood cell transfusion. The last 50mL of the transfusion will be labeled with chromium to allow investigators to study the lifespan of the red blood cells transfused into each patient.

Active Comparator: Non-G6DP deficient Red Blood Cell Transfusion
Transfusion of red blood cells that have been identified by local laboratory procedures to not be deficient in G6DP enzyme activity.
Biological: Red Blood Cell Transfusion
Patients will receive a red blood cell transfusion. The last 50mL of the transfusion will be labeled with chromium to allow investigators to study the lifespan of the red blood cells transfused into each patient.




Primary Outcome Measures :
  1. Post-Transfusion Recovery [ Time Frame: 24 hours ]
    Percentage of Red Blood Cells surviving post-transfusion


Secondary Outcome Measures :
  1. Hemoglobin A [ Time Frame: 4 weeks post-transfusion ]
    Change in hemoglobin A from pre-transfusion to 4 weeks post-transfusion



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 18-60 years
  2. HbSS/HbSβ0-thalassemia
  3. Stead state (no pain or baseline pain and ≥1 month from any hospital admission)
  4. Received ≥1 RBC transfusion in the past 2 years, but none in the past 120 days.

Exclusion Criteria:

  1. Currently on a chronic transfusion program
  2. History of transfusion reactions not adequately managed by antihistamines
  3. ≥2 alloantibodies or warm autoantibodies
  4. Known G6PD deficiency
  5. Known iron overload (ferritin >2000)
  6. Hepato- or splenomegaly
  7. Participation in another therapeutic trial
  8. Pregnant or nursing
  9. HIV positive
  10. At investigator discretion for uncontrolled inter-current illness or social situation limiting compliance with study requirements.
  11. Inability to speak and/or read English

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): NCT04028700


Contacts
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Contact: Matt Karafin, MD, MS 414-937-6833 mkarafin@versiti.org
Contact: Sarah Beggi 414-937-6833 sabeggi@versiti.org

Locations
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United States, Wisconsin
Medical College of Wisconsin and Froedtert Hospital
Milwaukee, Wisconsin, United States, 53226
Contact: Matt Karafin, MD,MS    414-937-6809    mkarafin@versiti.org   
Contact: Sarah Beggi    414-937-6833    sabeggi@versiti.org   
Sponsors and Collaborators
Versiti
Columbia University
Medical College of Wisconsin

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Responsible Party: Matthew Karafin, Principal Investigator, Versiti
ClinicalTrials.gov Identifier: NCT04028700    
Other Study ID Numbers: PRO00035124
First Posted: July 23, 2019    Key Record Dates
Last Update Posted: July 23, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn