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Blood Age in Transfusion for Sickle Cell Anemia

Phase 2 & 3

Recruiting

Led By Joshua Field, MD

Research Sponsored by Versiti

Eligibility Criteria Checklist

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

Must have

Diagnosis of sickle cell disease

Receiving outpatient red cell transfusion therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through fourth transfusion, an average of 24 weeks

Awards & highlights

Study Summary

This trial will help determine if transfusions of older red cells increase rates of infection in adults with Sickle Cell Disease.

Who is the study for?

This trial is for individuals aged 16 to 60 with sickle cell disease who are outpatients receiving red cell transfusion therapy. It's not suitable for those with a history of severe transfusion reactions, incompatible blood types, concurrent participation in other SCD trials, pregnancy, HIV positivity or uncontrolled illnesses that could affect study compliance.Check my eligibility

What is being tested?

The trial investigates if older blood (≥30 days old) affects the immune system and iron levels differently than fresher blood (≤10 days old) when given to adults with sickle cell disease. The effects will be studied biochemically, physiologically over three months, and through clinical outcomes.See study design

What are the potential side effects?

Potential side effects may include increased infection rates due to excess iron from older red cells triggering immune responses. Specific side effect profiles related to the age of transfused blood will be explored during the trial.

Eligibility Criteria

Inclusion Criteria

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

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I have been diagnosed with sickle cell disease.

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I am currently getting red blood cell transfusions as an outpatient.

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I will not be hospitalized when receiving my transfusion.

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I am between 16 and 60 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through fourth transfusion, an average of 24 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through fourth transfusion, an average of 24 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and through fourth transfusion, an average of 24 weeks for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Proportion of biochemically old red cell units

Other outcome measures

Body Weight Changes

Communicable Diseases

Side effects data

From 2014 Phase 3 trial • 118 Patients • NCT00003138

31%

Fatigue

23%

Pulmonary

15%

Infection

Cardiac adverse event

Diarrhea

Esophagitis

Hot flashes

Other toxicities

Hemorrhage

Skin

Weight loss

Neuropathy-clinical

Edema

Anemia

Neuropathy-psych

Abdominal cramps

100%

80%

60%

40%

20%

Study treatment Arm

Erythropoietin (300 Units/kg) and Filgrastim (Step 4)

Supportive Care (Step 1)

Erythropoietin (Step 1)

Erythropoietin (Cross-over; Step 2)

Erythropoietin (150 Units/kg) and Filgrastim (Step 3)

Trial Design

2Treatment groups

Experimental Treatment

Group I: ≥30 day BloodExperimental Treatment1 Intervention

Subjects in this group will receive only blood stored ≥30 days for 3 consecutive transfusion events.

Group II: ≤10 day BloodExperimental Treatment1 Intervention

Subjects in this group will receive only blood stored ≤10 days for 3 consecutive transfusion events.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Transfusion

2021

Completed Phase 3

~7150

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

VersitiLead Sponsor

15 Previous Clinical Trials

2,562 Total Patients Enrolled

University of North Carolina, Chapel HillLead Sponsor

1,504 Previous Clinical Trials

4,187,622 Total Patients Enrolled

National Heart, Lung, and Blood Institute (NHLBI)NIH

3,833 Previous Clinical Trials

47,306,456 Total Patients Enrolled

Media Library

Transfusion (Other) Clinical Trial Eligibility Overview. Trial Name: NCT03704922 — Phase 2 & 3

Sickle Cell Disease Research Study Groups: ≤10 day Blood, ≥30 day Blood

Sickle Cell Disease Clinical Trial 2023: Transfusion Highlights & Side Effects. Trial Name: NCT03704922 — Phase 2 & 3

Transfusion (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03704922 — Phase 2 & 3

Frequently Asked Questions

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

Which types of people are eligible to volunteer for this research?

"This particular research study is in need of 40 individuals that have sickle cell anemia and meet the following age, transfusion, and hemoglobin requirements: 16 to 60 years old, currently receiving red blood cell transfusions chronically, and have Hemoglobin SS/Hemoglobin Sβ-thalassemia^0."

Answered by AI

Will this clinical research be testing treatments on elderly participants?

"The age bracket for patients that this trial is recruiting falls between 16 and 60 years old."

Answered by AI

Are recruiting efforts for this experiment ongoing?

"This study, as reported on clinicaltrials.gov, is looking for patients to participate. The trial was originally posted on 10/4/2017 and last edited on 2/28/2022."

Answered by AI

Out of how many applicants will this clinical trial choose participants?

"That is correct, the trial detailed on clinicaltrials.gov is presently looking for 40 individuals at 2 locations. The listing was first published on October 4th, 2017 with the most recent update being February 28th, 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Age of Blood in Sickle Cell Transfusion

Matthew Karafin 2017. "Age of Blood in Sickle Cell Transfusion". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03704922.

All > Sickle Cell