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Transfusion for Sickle Cell Disease

Emory University, Atlanta, GA
Sickle Cell DiseaseTransfusion - Biological
Eligibility
16 - 60
All Sexes
What conditions do you have?
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Study Summary

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

Eligible Conditions
  • Sickle Cell Disease

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 2 & 3

Similar Trials

1
Red cell units that are genotype matched at the RHD and RHCE loci
1
D+ RH genotype matched red cell units for transfusion
1
Blood transfusion with SNO agent

Study Objectives

1 Primary · 0 Secondary · Reporting Duration: through fourth transfusion, an average of 24 weeks

Week 24
Communicable Diseases
Week 18
Body Weight Changes
Proportion of biochemically old red cell units

Trial Safety

Phase-Based Safety

2 of 3
This is further along than 68% of similar trials

Similar Trials

1
Red cell units that are genotype matched at the RHD and RHCE loci
1
D+ RH genotype matched red cell units for transfusion
1
Blood transfusion with SNO agent

Side Effects for

Erythropoietin (300 Units/kg) and Filgrastim (Step 4)
31%Fatigue
23%Pulmonary
15%Infection
8%Other toxicities
8%Hemorrhage
8%Esophagitis
8%Edema
8%Diarrhea
8%Neuropathy-psych
8%Skin
8%Hot flashes
8%Weight loss
8%Neuropathy-clinical
8%Cardiac adverse event
8%Anemia
8%Abdominal cramps
This histogram enumerates side effects from a completed 2014 Phase 3 trial (NCT00003138) in the Erythropoietin (300 Units/kg) and Filgrastim (Step 4) ARM group. Side effects include: Fatigue with 31%, Pulmonary with 23%, Infection with 15%, Other toxicities with 8%, Hemorrhage with 8%.

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

2 Treatment Groups

≤10 day Blood
1 of 2
≥30 day Blood
1 of 2

Experimental Treatment

40 Total Participants · 2 Treatment Groups

Primary Treatment: Transfusion · No Placebo Group · Phase 2 & 3

≤10 day Blood
Biological
Experimental Group · 1 Intervention: Transfusion · Intervention Types: Biological
≥30 day Blood
Biological
Experimental Group · 1 Intervention: Transfusion · Intervention Types: Biological
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Transfusion
2013
Completed Phase 3
~1340

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: through fourth transfusion, an average of 24 weeks

Who is running the clinical trial?

VersitiLead Sponsor
15 Previous Clinical Trials
2,562 Total Patients Enrolled
University of North Carolina, Chapel HillLead Sponsor
1,396 Previous Clinical Trials
3,743,834 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,672 Previous Clinical Trials
47,133,302 Total Patients Enrolled
Joshua Field, MDPrincipal InvestigatorVersiti
Jane Little, MDPrincipal InvestigatorUniversity of North Carolina, Chapel Hill
3 Previous Clinical Trials
8 Total Patients Enrolled
Matthew Karafin, MD, MSPrincipal Investigator - University of North Carolina, Chapel Hill
Versiti
1 Previous Clinical Trials
16 Total Patients Enrolled

Eligibility Criteria

Age 16 - 60 · All Participants · 1 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are currently receiving red blood cell transfusions as an outpatient.
References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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