The Impact of Oxidative Stress on Erythrocyte Biology

Sickle Cell Disease Without Crisis Clinical Trial

— RBC Survival  

Official title:

Red Blood Cell Survival Study: The Impact of Oxidative Stress on Erythrocyte Biology

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04028700
• Other study ID #: 21-0587
• Secondary ID: R01HL148151-01
• Status: Recruiting
• Phase: Phase 2
• Start date: January 2, 2022
• Est. completion date: October 31, 2024

Study information

• Verified date: April 2024
• Source: University of North Carolina, Chapel Hill
• Contact: David Wichlan
• Phone: 919-966-6876
• Email: david_wichlan[@]med.unc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will address if red blood cells transfused to a sickle cell patient from a donor with a glucose-6-phosphate-dehydrogenase (G6PD) enzyme deficiency have a different lifespan as measured by the percentage of red blood cells that survive post-transfusion compared to red blood cells transfused to a sickle cell patient from a donor without a G6PD enzyme deficiency.

Description:

This prospective, phase II, crossover, single-blind, randomized transfusion order study will address if red blood cells from donors with a G6PD enzyme deficiency have a different lifespan once transfused into a patient with sickle cell disease than red blood cells from an otherwise normal donor. Results of this critical study will guide future research and donor testing policies to ensure that patients receive the most appropriate units of blood for their condition. Each patient randomized to the study will receive 2 blood transfusions, one from a G6PD deficient donor and one from an otherwise normal donor. Half the patients (8) will receive G6PD deficient blood first while the other half (8) will receive non-G6PD deficient blood first. Patients will have a wash-out period of at least 4 months before receiving the opposite type of blood transfusion. The blood transfusion order will be randomized. There is currently no standard of testing in place to screen blood donations for G6PD enzyme deficiency. It is believed that up to 10% of the antigen-matched donors for patients with sickle cell disease are G6PD deficient, and the lifespan is unknown in the sickle cell population.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 16
• Est. completion date: October 31, 2024
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Age 18-60 years
• Has diagnosis of sickle cell disease
• Steady state (no pain or baseline pain and =1 month from any hospital admission)
• Receiving chronic transfusions (i.e., regular transfusion every 4-8 weeks).

Exclusion Criteria:

• History of transfusion reactions not adequately managed by antihistamines
• Does not have crossmatch compatible red cells
• Known G6PD deficiency
• Hepato- or splenomegaly
• Participation in another therapeutic trial
• Pregnant or nursing
• HIV positive
• At investigator discretion for uncontrolled inter-current illness or social situation limiting compliance with study requirements.
• Inability to speak and/or read English

Related Conditions & MeSH terms

• Anemia, Sickle Cell
• Sickle Cell Disease Without Crisis

Intervention

Biological:
• G6PD Deficient Red Blood Cell Transfusion
Patients will receive a red blood cell transfusion. The last 50 mL of the transfusion will be labeled with chromium to allow investigators to study the lifespan of the red blood cells transfused into each patient.
• Non-G6PD deficient Red Blood Cell Transfusion
Patients will receive a red blood cell transfusion. The last 50 mL of the transfusion will be labeled with chromium to allow investigators to study the lifespan of the red blood cells transfused into each patient.

Locations

Country	Name	City	State
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina

Sponsors (3)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	Columbia University, National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Red Blood Cells Surviving	Post-Transfusion Recovery	24 hours post-transfusion
Secondary	Mean Percent Change in Hemoglobin A	Hemoglobin A	1 hour post-transfusion, 4 weeks post-transfusion