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出境医 / 临床实验 / The Impact of Oxidative Stress on Erythrocyte Bilogy (RBC Survival)

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

Study Description
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.
Study Design
Layout table for study information
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 : November 1, 2020
Estimated Primary Completion Date : October 1, 2023
Estimated Study Completion Date : October 1, 2023
Arms and Interventions
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.
Outcome Measures
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


Eligibility Criteria
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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
Contacts and Locations

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
Layout table for location information
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
Tracking Information
First Submitted Date  ICMJE July 19, 2019
First Posted Date  ICMJE July 23, 2019
Last Update Posted Date May 6, 2020
Estimated Study Start Date  ICMJE November 1, 2020
Estimated Primary Completion Date October 1, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 19, 2019) 		Post-Transfusion Recovery [ Time Frame: 24 hours ]
Percentage of Red Blood Cells surviving post-transfusion
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 19, 2019) 		Hemoglobin A [ Time Frame: 4 weeks post-transfusion ]
Change in hemoglobin A from pre-transfusion to 4 weeks post-transfusion
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Impact of Oxidative Stress on Erythrocyte Bilogy
Official Title  ICMJE Red Blood Cell Survival Study: The Impact of Oxidative Stress on Erythrocyte Bilogy
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE 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
Condition  ICMJE Sickle Cell Disease Without Crisis
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.
    Intervention: Biological: Red Blood Cell Transfusion
  • 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.
    Intervention: Biological: Red Blood Cell 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 Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: July 19, 2019) 		16
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 1, 2023
Estimated Primary Completion Date October 1, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Matt Karafin, MD, MS 414-937-6833 mkarafin@versiti.org
Contact: Sarah Beggi 414-937-6833 sabeggi@versiti.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04028700
Other Study ID Numbers  ICMJE PRO00035124
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Matthew Karafin, Versiti
Study Sponsor  ICMJE Versiti
Collaborators  ICMJE
  • Columbia University
  • Medical College of Wisconsin
Investigators  ICMJE Not Provided
PRS Account Versiti
Verification Date May 2020

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

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