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Blood Transfusion

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

Phase 3
Recruiting
Led By Mark Gladwin, MD
Research Sponsored by Mark Gladwin
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).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4, 8 and 12 months
Awards & highlights

SCD-CARRE Trial 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.Check my eligibility
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.See study design
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.

SCD-CARRE Trial 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.

SCD-CARRE Trial 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

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

SCD-CARRE 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?

Mark GladwinLead Sponsor
2 Previous Clinical Trials
183 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,836 Previous Clinical Trials
47,850,748 Total Patients Enrolled
Gladwin, Mark, MDLead Sponsor
14 Previous Clinical Trials
283 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

Frequently Asked Questions

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

How many people are included in the research project?

"That is accurate. The clinicaltrials.gov website currently lists this study as open for recruitment. This particular research project was made public on February 26th 2020 with the most recent update being August 23rd 2022. There are 18 sites where this trial is taking place and a total of 150 people are needed for the full data set."

Answered by AI

Has the FDA given permission for Red Blood Cell to be used as a medication?

"There is some data to support the efficacy of Red Blood Cell, as well as multiple rounds of data affirming its safety. Consequently, it received a score of 3 on our Power scale."

Answered by AI

Are patients currently being enrolled in this research project?

"The clinical trial is currently looking for participants. Based on the information found on clinicaltrials.gov, this study was first posted on February 26th 2020 and was last updated on August 23rd, 2022."

Answered by AI

How many different locations are conducting this trial?

"Right now, there are 18 centres enrolling patients for this trial. If you live near Boston, Columbus or Chicago, great! There will be less travelling required of you. However, if not, don't worry; there are plenty of other locations across the country that you can choose from."

Answered by AI

Who else is applying?

What site did they apply to?
Howard University Center for Sickle Cell Disease
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
~43 spots leftby Dec 2025