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Blood Transfusion

Red Blood Cell Exchange for Sickle Cell Disease (SCD-CARRE Trial)

Phase 3
Recruiting
Led By Maria Brooks, PhD
Research Sponsored by University of Pittsburgh
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 18 years or older
Chronic kidney disease (CKD) due to SCD with abnormal measures on 2 separate occasions as defined by: macroalbuminuria (albumin to creatinine ratio (ACR) >300 mg/g) or proteinuria (protein to creatinine ratio >30 mg/mmol), or estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m2. (It is recommended that local laboratories use Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] equation without ethnic factors when estimating and reporting GFR).
Must not have
Previous history of severe transfusion reaction resulting in renal failure or due to serious complications such as hypotension or respiratory distress
More than 10 vaso-occlusive episodes in the past 12 months requiring admission to a hospital to receive treatment.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4, 8 and 12 months
Awards & highlights
Pivotal Trial
No Placebo-Only Group

Summary

This trial is testing whether a new treatment for sickle cell disease (SCD) is better than the current standard of care.

Who is the study for?
Adults over 18 with Sickle Cell Disease at high risk of health complications, not on chronic blood exchange for 60 days, stable medication doses if taking SCD drugs. Excludes those with a history of severe transfusion reactions or conditions like liver failure that increase trial risks.
What is being tested?
The SCD-CARRE study is testing whether automated red blood cell exchanges plus standard care can reduce health emergencies or death in high-risk adult sickle cell patients compared to standard care alone over a year.
What are the potential side effects?
Potential side effects may include reactions related to blood transfusions such as fever, allergic responses, and in rare cases more serious issues like hemolysis (breakdown of red cells) or infection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I have kidney issues from sickle cell disease, confirmed by tests.
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I have been diagnosed with a specific type of sickle cell disease.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I've had a severe reaction to a blood transfusion causing kidney failure or serious issues like low blood pressure or breathing problems.
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I've been hospitalized over 10 times in the last year for pain crises.
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I am of childbearing age and my pregnancy test is positive.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4, 8 and 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4, 8 and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Episodes of clinical worsening
Secondary study objectives
Acute healthcare event
Cardiovascular function by echocardiography - TRV
Cardiovascular function by echocardiography - diastolic left heart function
+13 more

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Exchange transfusion plus standard of careExperimental Treatment2 Interventions
Randomized to standard of care and automated exchange blood transfusion every 3-6 weeks for 12 months.
Group II: Standard of careActive Control1 Intervention
Randomized to standard of care

Find a Location

Who is running the clinical trial?

University of PittsburghLead Sponsor
1,789 Previous Clinical Trials
16,359,473 Total Patients Enrolled
Mark GladwinLead Sponsor
2 Previous Clinical Trials
183 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,936 Previous Clinical Trials
47,792,503 Total Patients Enrolled

Media Library

Automated Exchange Blood Transfusion (Blood Transfusion) Clinical Trial Eligibility Overview. Trial Name: NCT04084080 — Phase 3
Sickle Cell Disease Research Study Groups: Standard of care, Exchange transfusion plus standard of care
Sickle Cell Disease Clinical Trial 2023: Automated Exchange Blood Transfusion Highlights & Side Effects. Trial Name: NCT04084080 — Phase 3
Automated Exchange Blood Transfusion (Blood Transfusion) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04084080 — Phase 3
~36 spots leftby May 2026
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