Effect of G6PD Deficiency on Red Blood Cell Storage

NCT04081272 | Completed FDA Drug

• 1 other identifier: AAAJ6862
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 2

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.

Conditions

G6PD Deficiency

Keywords

transfusion; post-transfusion recovery

Outcome Measures

Primary Outcomes (1)

• 24-hour post-transfusion red blood cell recovery

  Percentage of radio-labeled red blood cells remaining 24 hours after infusion

  24 hours

Secondary Outcomes (1)

• In vitro hemolysis rate

  42 days

Other Outcomes (1)

• Number of samples with metabolites detected

  Pre-donation to 42 days after donation

Study Arms (2)

G6PD-normal

Donated blood from G6PD-normal subjects

Drug: Sodium Chromate Cr51

G6PD-deficient

Donated blood from G6PD-deficient subjects

Drug: Sodium Chromate Cr51

Interventions

Sodium Chromate Cr51 DRUG

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

Also known as: Chromitope

G6PD-deficient; G6PD-normal

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy male volunteers will be screened for G6PD deficiency in order to identify 10 G6PD deficient and 30 matched normal individuals using a blood sample obtained from a finger-stick.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Columbia University: lead
• New York Blood Center: collaborator

Study Sites (2)

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

New York Blood Center

New York, New York, 10065, United States

Location

Related Publications (1)

• Francis RO, D'Alessandro A, Eisenberger A, Soffing M, Yeh R, Coronel E, Sheikh A, Rapido F, La Carpia F, Reisz JA, Gehrke S, Nemkov T, Thomas T, Schwartz J, Divgi C, Kessler D, Shaz BH, Ginzburg Y, Zimring JC, Spitalnik SL, Hod EA. Donor glucose-6-phosphate dehydrogenase deficiency decreases blood quality for transfusion. J Clin Invest. 2020 May 1;130(5):2270-2285. doi: 10.1172/JCI133530.

  PMID: 31961822 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood will be collected to conduct a complete blood count (CBC), testing for the presence of abnormal hemoglobin types (hemoglobinopathy screen), blood type and antibody screen, and confirmation of G6PD deficiency by measuring enzyme activity. In addition, DNA will be extracted and preserved for genetic testing for G6PD deficiency.

MeSH Terms

Conditions

Glucosephosphate Dehydrogenase Deficiency

Interventions

sodium chromate(VI)

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Carbohydrate Metabolism, Inborn Errors; Metabolism, Inborn Errors; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Richard O Francis, MD, PhD

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2019
• First Posted: September 9, 2019
• Study Start: November 1, 2012
• Primary Completion: August 1, 2017
• Study Completion: October 1, 2017
• Last Updated: September 17, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: upon request once the study is published
• Access Criteria: email study PI to request data

Locations

US (2)