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

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ClinicalTrials.gov Identifier: NCT04028700
Recruitment Status : Recruiting
First Posted : July 23, 2019
Last Update Posted : March 2, 2022
Sponsor:
Collaborators:
Columbia University
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Brief Summary:
This study will address if red blood cells transfused to a sickle cell patient from a donor with a glucose-6-phosphate-dehydrogenase (G6PD) 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 G6PD enzyme deficiency.

Condition or disease Intervention/treatment Phase
Sickle Cell Disease Without Crisis Biological: G6PD Deficient Red Blood Cell Transfusion Biological: Non-G6PD deficient 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 G6PD 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 G6PD deficient donor and one from an otherwise normal donor. Half the patients (8) will receive G6PD deficient blood first while the other half (8) will receive non-G6PD deficient blood first. Patients will have a wash-out period of at least 4 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 G6PD enzyme deficiency. It is believed that up to 10% of the antigen-matched donors for patients with sickle cell disease are G6PD 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 Biology
Actual Study Start Date : January 2, 2022
Estimated Primary Completion Date : October 2024
Estimated Study Completion Date : October 2024


Arm Intervention/treatment
Experimental: G6PD Deficient Red Blood Cell Transfusion, then Non-G6PD deficient Red Blood Cell Transfusion
Transfusion of a red blood cell unit that has been identified by local laboratory procedures to be deficient in G6PD enzyme activity followed after 4 months by transfusion of a red blood cell unit that has been identified by local laboratory procedures to not be deficient in G6PD enzyme activity.
Biological: G6PD Deficient Red Blood Cell Transfusion
Patients will receive a red blood cell transfusion. The last 50 mL of the transfusion will be labeled with chromium to allow investigators to study the lifespan of the red blood cells transfused into each patient.

Biological: Non-G6PD deficient Red Blood Cell Transfusion
Patients will receive a red blood cell transfusion. The last 50 mL 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-G6PD deficient Red Blood Cell Transfusion, then G6PD Deficient Red Blood Cell Transfusion,
Transfusion of a red blood cell unit that has been identified by local laboratory procedures to not be deficient in G6PD enzyme activity followed after 4 months by transfusion of a red blood cell unit that has been identified by local laboratory procedures to be deficient in G6PD enzyme activity
Biological: G6PD Deficient Red Blood Cell Transfusion
Patients will receive a red blood cell transfusion. The last 50 mL of the transfusion will be labeled with chromium to allow investigators to study the lifespan of the red blood cells transfused into each patient.

Biological: Non-G6PD deficient Red Blood Cell Transfusion
Patients will receive a red blood cell transfusion. The last 50 mL 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. Percentage of Red Blood Cells Surviving [ Time Frame: 24 hours post-transfusion ]
    Post-Transfusion Recovery


Secondary Outcome Measures :
  1. Mean Percent Change in Hemoglobin A [ Time Frame: 1 hour post-transfusion, 4 weeks post-transfusion ]
    Hemoglobin A



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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:

  • Age 18-60 years
  • HbSS/HbSβ0-thalassemia
  • Steady state (no pain or baseline pain and ≥1 month from any hospital admission)
  • Receiving chronic transfusions (i.e regular transfusion every 4-8 weeks).

Exclusion Criteria:

  • History of transfusion reactions not adequately managed by antihistamines
  • ≥2 alloantibodies or warm autoantibodies
  • Known G6PD deficiency
  • Hepato- or splenomegaly
  • Participation in another therapeutic trial
  • Pregnant or nursing
  • HIV positive
  • At investigator discretion for uncontrolled inter-current illness or social situation limiting compliance with study requirements.
  • 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: David Wichlan 919-966-6876 david_wichlan@med.unc.edu

Locations
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United States, North Carolina
University of North Carolina at Chapel Hill Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: David Wichlan    919-966-6876    david_wichlan@med.unc.edu   
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Columbia University
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: Matthew Karafin, MD, MS University of North Carolina, Chapel Hill
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Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT04028700    
Other Study ID Numbers: 21-0587
R01HL148151-01 ( U.S. NIH Grant/Contract )
First Posted: July 23, 2019    Key Record Dates
Last Update Posted: March 2, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: 9 to 36 months following publication
Access Criteria: Investigator proposing to use the data has approval from an IRB, IEC, or REB and an executed data use/sharing agreement with UNC.

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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