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Red Blood Cell Transfusion

Red Blood Cell Transfusion Impact for Sickle Cell Disease (RBC Survival Trial)

Phase 2

Recruiting

Led By Matthew Karafin, MD, MS

Research Sponsored by Versiti

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Receiving chronic transfusions (i.e regular transfusion every 4-8 weeks).

Age 18-60 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 hours post-transfusion

Awards & highlights

RBC Survival Trial Summary

This trial will compare the lifespan of red blood cells transfused to sickle cell patients, depending on whether the donor has a glucose-6-phosphate-dehydrogenase (G6PD) enzyme deficiency.

Who is the study for?

This trial is for adults aged 18-60 with Sickle Cell Disease who are in a stable condition and regularly receive blood transfusions. It's not for those with organ enlargement, G6PD deficiency, HIV, language barriers, multiple blood transfusion allergies or antibodies, pregnant/nursing women, or other conditions that affect study participation.Check my eligibility

What is being tested?

The study tests if red blood cells from donors without the G6PD enzyme have different lifespans when given to sickle cell patients compared to cells from donors with this deficiency. The survival of these cells post-transfusion is measured.See study design

What are the potential side effects?

While specific side effects aren't listed for this trial, general risks may include allergic reactions to transfused blood and complications related to mismatched blood types.

RBC Survival Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I regularly get blood transfusions every 4-8 weeks.

Select...

I am between 18 and 60 years old.

Select...

I have sickle cell disease (HbSS or HbSβ0-thalassemia).

RBC Survival Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 hours post-transfusion

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 hours post-transfusion

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 hours post-transfusion for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Percentage of Red Blood Cells Surviving

Secondary outcome measures

Mean Percent Change in Hemoglobin A

RBC Survival Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: G6PD Deficient Red Blood Cell Transfusion, then Non-G6PD deficient Red Blood Cell TransfusionExperimental Treatment2 Interventions

Transfusion of a red blood cell unit that has been identified by local laboratory procedures to be deficient in G6PD enzyme activity followed after 4 months by transfusion of a red blood cell unit that has been identified by local laboratory procedures to not be deficient in G6PD enzyme activity.

Group II: Non-G6PD deficient Red Blood Cell Transfusion, then G6PD Deficient Red Blood Cell Transfusion,Active Control2 Interventions

Transfusion of a red blood cell unit that has been identified by local laboratory procedures to not be deficient in G6PD enzyme activity followed after 4 months by transfusion of a red blood cell unit that has been identified by local laboratory procedures to be deficient in G6PD enzyme activity

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

VersitiLead Sponsor

15 Previous Clinical Trials

2,586 Total Patients Enrolled

University of North Carolina, Chapel HillLead Sponsor

1,508 Previous Clinical Trials

4,190,600 Total Patients Enrolled

Columbia UniversityOTHER

1,432 Previous Clinical Trials

2,460,957 Total Patients Enrolled

Media Library

G6PD Deficient Red Blood Cell Transfusion (Red Blood Cell Transfusion) Clinical Trial Eligibility Overview. Trial Name: NCT04028700 — Phase 2

Sickle Cell Disease Research Study Groups: Non-G6PD deficient Red Blood Cell Transfusion, then G6PD Deficient Red Blood Cell Transfusion,, G6PD Deficient Red Blood Cell Transfusion, then Non-G6PD deficient Red Blood Cell Transfusion

Sickle Cell Disease Clinical Trial 2023: G6PD Deficient Red Blood Cell Transfusion Highlights & Side Effects. Trial Name: NCT04028700 — Phase 2

G6PD Deficient Red Blood Cell Transfusion (Red Blood Cell Transfusion) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04028700 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the age criterion for this clinical trial encompass individuals under 55 years of age?

"The accepted range of ages for this research is between 18 and 60, as detailed in the trial's inclusion criteria."

Answered by AI

Does the FDA currently sanction G6PD Deficient Red Blood Cell Transfusion?

"Although evidence of effectiveness has yet to be demonstrated, there is some prior data supporting the safety of G6PD Deficient Red Blood Cell Transfusion; thus it scored a 2."

Answered by AI

What is the maximum allowable enrollment for this experiment?

"Affirmative. The details hosted on clinicaltrials.gov demonstrate that this medical trial, initially posted on 2nd January 2022, is currently enlisting participants. Approximately 16 individuals must be enlisted from two distinct sites."

Answered by AI

Are there any opportunities to volunteer for this clinical research at present?

"According to clinicaltrials.gov, the trial is currently recruiting volunteers and was initially posted on January 2nd 2022 with a subsequent update occuring August 15th of this year."

Answered by AI

Am I eligible to participate in the research project?

"For qualification, applicants must have anemic blood and suffer from sickle cell disease. Additionally these individuals should be between 18 to 60 years of age given the parameters set by this study which aims to recruit 16 participants in total."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

The Impact of Oxidative Stress on Erythrocyte Biology

Matthew Karafin 2022. "The Impact of Oxidative Stress on Erythrocyte Biology". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04028700.

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