Effect of G6PD Deficiency on Red Blood Cell Storage

Completed

• Conditions: G6PD Deficiency
• Interventions: Drug: Sodium Chromate Cr51

• Registration Number: NCT04081272
• Lead Sponsor: Columbia University

Brief Summary

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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2012-11
• Primary Completion: 2017-08
• Study Completion: 2017-10
• Status Verified: 2019-09
• Study First Submitted: 2019-09-05
• Study First Submitted QC: 2019-09-05
• Study First Posted: 2019-09-09
• Last Update Submitted: 2019-09-16
• Last Update Posted: 2019-09-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 40

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
G6PD-deficient	Sodium Chromate Cr51	Donated blood from G6PD-deficient subjects
G6PD-normal	Sodium Chromate Cr51	Donated blood from G6PD-normal subjects

Primary Outcome Measures

Name	Time	Method
24-hour post-transfusion red blood cell recovery	24 hours	Percentage of radio-labeled red blood cells remaining 24 hours after infusion

Secondary Outcome Measures

Name	Time	Method
In vitro hemolysis rate	42 days	Percent hemolysis in the red blood cell unit in vitro

Trial Locations

Locations (2)

Columbia University Irving Medical Center; 🇺🇸 New York, New York, United States

New York Blood Center; 🇺🇸 New York, New York, United States