Effect of G6PD Deficiency on Red Blood Cell Storage

Overview

The proposed study will determine whether G6PD-deficient RBCs store differently than normal RBCs under standard blood banking conditions. The investigators plan to screen a large number of healthy male volunteers for G6PD deficiency in order to identify 10 G6PD deficient and 30 matched normal individuals using a blood sample obtained from a finger-stick. The identified individuals will then be asked to donate a unit of blood that will be stored for up to 42 days and various tests will be performed on these units during storage. At 6 weeks of storage a portion of the unit will be radioactively labeled and re-infused into the volunteer. Blood samples will be drawn before, during, and after the infusion to measure how well or poorly the red blood cells survive after transfusion.

Full Title of Study: “Effect of Glucose-6-phosphate Dehydrogenase Deficiency on Donor Red Blood Cell Storage”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: August 2017

Detailed Description

Glucose-6-phosphate dehydrogenase (G6PD) deficiency is the most common enzyme deficiency, affecting approximately 400 million people world-wide. It manifests as red blood cell (RBC) destruction in response to oxidative stress, which can be precipitated by infection, and by the ingestion of certain medications and foods. The prevalence of G6PD deficiency varies among populations and is most commonly found in individuals from sub-Saharan Africa, the Mediterranean region, and south-east Asia. Although in most studies G6PD-deficient individuals have normal RBC survival at steady-state, this may vary based upon the G6PD variant present, and some individuals may have shortened RBC survival. While it is not routine practice to screen blood donors for G6PD deficiency, G6PD deficient donor RBCs may store more poorly than normal RBCs. In addition, the transfusion of stored G6PD-deficient RBCs may result in decreased RBC survival after transfusion compared to RBCs from normal donors.

Interventions

  • Drug: Sodium Chromate Cr51
    • Sodium Chromate Cr 51 will be used to perform a red blood cell recovered study 24 hours post-transfusion.

Arms, Groups and Cohorts

  • G6PD-normal
    • Donated blood from G6PD-normal subjects
  • G6PD-deficient
    • Donated blood from G6PD-deficient subjects

Clinical Trial Outcome Measures

Primary Measures

  • 24-hour post-transfusion red blood cell recovery
    • Time Frame: 24 hours
    • Percentage of radio-labeled red blood cells remaining 24 hours after infusion

Secondary Measures

  • In vitro hemolysis rate
    • Time Frame: 42 days
    • Percent hemolysis in the red blood cell unit in vitro

Participating in This Clinical Trial

Inclusion Criteria

  • Male
  • Weight greater than 110 pounds
  • Hemoglobin greater than 11.5 g/dL
  • African (e.g., Afro-American, Afro-Caribbean, Sub-Saharan), Asian, Hispanic, Middle Eastern, or Mediterranean (e.g., Italian, Greek) based on mother's ancestry
  • English speaking

Exclusion Criteria

  • Presence of hemoglobin variant
  • Ineligible for donation based on the New York Blood Center donor autologous questionnaire
  • Systolic blood pressure >180 or <90 mm Hg, diastolic blood pressure >100 or <50 mm Hg
  • Heart rate <50 or >100
  • Temperature >99.5°F prior to donation
  • Temperature >100.4°F or subjective feeling of illness prior to transfusion (this criterion is to avoid concurrent illness affecting post-transfusion measurements)
  • Positive results on standard blood donor infectious disease testing

Gender Eligibility: Male

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Columbia University
  • Collaborator
    • New York Blood Center
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Richard O Francis, MD, PhD, Principal Investigator, Columbia University Irving Medical Center

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