Effect of G6PD Deficiency on Red Blood Cell Storage

G6PD Deficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04081272
• Other study ID #: AAAJ6862
• Status: Completed
• Start date: November 2012
• Est. completion date: October 2017

Study information

• Verified date: September 2019
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• G6PD Deficiency
• Glucosephosphate Dehydrogenase Deficiency

Intervention

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

Locations

Country	Name	City	State
United States	Columbia University Irving Medical Center	New York	New York
United States	New York Blood Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Columbia University	New York Blood Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of samples with metabolites detected	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.	Pre-donation to 42 days after donation
Primary	24-hour post-transfusion red blood cell recovery	Percentage of radio-labeled red blood cells remaining 24 hours after infusion	24 hours
Secondary	In vitro hemolysis rate	Percent hemolysis in the red blood cell unit in vitro	42 days