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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 belowSelect...
I am 18 years old or older.
Select...
I have kidney issues from sickle cell disease, confirmed by tests.
Select...
I have been diagnosed with a specific type of sickle cell disease.
SCD-CARRE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4, 8 and 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4, 8 and 12 months
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 moreSCD-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
3,840 Previous Clinical Trials
47,851,974 Total Patients Enrolled
Gladwin, Mark, MDLead Sponsor
14 Previous Clinical Trials
283 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I've had a severe reaction to a blood transfusion causing kidney failure or serious issues like low blood pressure or breathing problems.I've been hospitalized over 10 times in the last year for pain crises.I haven't been on a regular blood exchange program for the last 60 days.My eligibility biomarkers were tested in a stable condition, not during an acute pain event.I am 18 years old or older.I have kidney issues from sickle cell disease, confirmed by tests.You have had a condition called hyper-hemolysis syndrome in the past.You have a religious belief that prevents you from receiving a blood transfusion.I am of childbearing age and my pregnancy test is positive.I had a stroke caused by a blood clot in the last 6 months.My sickle cell disease medication dose has been stable for at least 60 days.I do not have liver failure, advanced cirrhosis, or any condition that would make this trial too risky for me.I have been diagnosed with a specific type of sickle cell disease.
Research Study Groups:
This trial has the following groups:- Group 1: Standard of care
- Group 2: Exchange transfusion plus standard of care
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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
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