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Completed

NCT Number: NCT04081272

Effect of G6PD Deficiency on Red Blood Cell Storage

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.

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Key information

Age range

18 year–70 year

Sex eligibility

Male

Study type

Observational

Primary location

Columbia University Irving Medical Center, New York, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sodium Chromate Cr51

Drug

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

Other names: Chromitope

Primary outcomes

  1. 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 outcomes

  1. In vitro hemolysis rate

    Time frame: 42 days

    Percent hemolysis in the red blood cell unit in vitro

Other outcomes

  1. Number of samples with metabolites detected

    Time frame: Pre-donation to 42 days after donation

    Metabolomics analysis: metabolites that are representative of major metabolic pathways will be measured in the red blood cells or supernatant during storage. Quantitative measurements will be performed using high performance liquid chromatography and mass spectrometry and the data obtained will be analyzed to detect correlations with the primary outcome measure of 24-hour post-transfusion red blood cell recovery.

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Collaborators

  • New York Blood Center

Registry information

Official study title

Effect of Glucose-6-phosphate Dehydrogenase Deficiency on Donor Red Blood Cell Storage

Important dates

Study start
2012
Primary completion
2017
Study completion
2017
First posted
Sep 9, 2019
Registry last updated
Sep 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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