Sickle Cell DiseasePhase 3SCD-CARRENCT04084080
Sickle Cell Disease and CardiovAscular Risk - Red Cell Exchange Trial (SCD-CARRE)
A Phase 3 study testing Red Blood Cell in people with Sickle Cell Disease, run by University of Pittsburgh at 23 sites in 3 countries.
Trial summary
The SCD-CARRE trial is a Phase 3, prospective, randomized, multicenter, controlled, parallel two-arm study aimed to determine if automated exchange blood transfusion and standard of care administered to high mortality risk adult SCD patients reduces the total number of episodes of clinical worsening of SCD requiring… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sickle Cell Disease
- What is being tested?
- Red Blood Cell
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 173 participants
- Where
- 23 sitesin 3 countries
- Study dates
- 26 Feb 2020to 31 Oct 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older
- Diagnosis of SCD: homozygous sickle cell disease, hemoglobin-SC, Sβ-thalassemia, hemoglobin-SO or hemoglobin-SD.
- Patients not on a chronic exchange transfusion program for at least 60 days.
- If patients are on a SCD drug (e.g. hydroxyurea, glutamine, or P-selectin inhibitors), the doses must be stable for at least 60 days prior to randomization. At the time of randomization, participants must be off Oxbryta for at least 30 days.
- Any one of the following vasculopathy biomarker clinical results (a, b, c, d or e) measured in the last 24 months before randomization that indicates a high-risk patient:
- Both a TRV 2.5- <3.0 m/sec and NT-proBNP plasma level ≥ 160 pg/mL,
Show all 12Show fewer
- TRV ≥ 3.0 m/sec,
- Both a mean pulmonary artery pressure (PAP) by right heart catheterization 20-24 mmHg and NT-proBNP plasma level ≥ 160 pg/mL,
- Mean PAP by right heart catheterization ≥ 25 mmHg,
- 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).
- Clinical results of these biomarkers measured locally at sites within 24 months prior to randomization are acceptable to determine eligibility. TRV, PAP, NT-proBNP, albumin to creatinine ratio, protein to creatinine ratio, or eGFR values must be measured in a steady state (defined as measured ≥ 14 days since an acute care pain event) on different days.
- Written informed consent obtained from patient to participate in the trial.
Who cannot join
- RBC alloimmunization resulting in inability of blood bank to obtain compatible components for chronic exchange transfusions
- Previous history of hyper-hemolysis syndrome
- 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.
- Religious objection to receiving blood transfusion
- Diagnosis of ischemic stroke within the past 6 months
- Clinical evidence of liver failure or advanced cirrhosis or any co-existing medical condition that in the Investigator's judgement will substantially increase the risk associated with the patient's participation in the trial
- Women of childbearing potential who have a positive pregnancy test at baseline
Trial locations and contacts
23 sites in 3 countries.
23 sites in 3 countries
United States20 sites
Emory University
Atlanta, Georgia, 30322
University of Maryland
Baltimore, Maryland, 21201
Johns Hopkins University
Baltimore, Maryland, 21206
Boston Medical Center
Boston, Massachusetts, 02118
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
Atrium Health
Charlotte, North Carolina, 28204
University of Illinois at Chicago
Chicago, Illinois, 60607
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
Ohio State University
Columbus, Ohio, 43210
Duke University
Durham, North Carolina, 27708
East Carolina University
Greenville, North Carolina, 27834
University of Texas Health Science Center at Houston
Houston, Texas, 77030
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Montefiore Medical Center
New York, New York, 10461
UCSF Benioff Children's Hospital Oakland
Oakland, California, 94609
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15232
Virginia Commonwealth University
Richmond, Virginia, 23284
Washington University-St. Louis
St Louis, Missouri, 63110
University of Alabama
Tuscaloosa, Alabama, 35401
Howard University Center for Sickle Cell Disease
Washington D.C., District of Columbia, 20060
About this study
The SCD-CARRE trial is a Phase 3, prospective, randomized, multicenter, controlled, parallel two-arm study aimed to determine if automated exchange blood transfusion and standard of care administered to high mortality risk adult SCD patients reduces the total number of episodes of clinical worsening of SCD requiring acute health care encounters (non-elective infusion center/ER/hospital visits) or resulting in death over 12 months as compared with standard of care.
Read the detailed description
As patients with sickle cell disease (SCD) live to adulthood, the chronic impact of sustained hemolytic anemia and episodic vaso-occlusive events take their toll, with the progressive development of cardiopulmonary organ dysfunction. This culminates in the development of pulmonary hypertension, left ventricular diastolic heart disease, dysrhythmia, chronic kidney disease and sudden death, all major cardiovascular complications of SCD for which there are no approved or consensus therapies. The risk of having pulmonary hypertension and diastolic heart disease can be non-invasively assessed by laboratory tests (NT-proBNP) and Doppler-echocardiography (estimated pulmonary artery systolic pressure). A recent meta-analysis of approximately 6000 patients with SCD demonstrated that patients with elevated tricuspid regurgitant jet velocity (TRV), which is an Doppler-echocardiographic measurement that estimates the pulmonary artery systolic pressure, walked an estimated 30.4 meters less in a 6 minute walk test than those without elevated TRV, and elevated TRV was associated with high mortality (hazard ratio of 4.9). In two large registry cohorts of adult patients with SCD, the investigators found that approximately 20% of the adult SCD population have high values for both biomarkers, defined as a TRV ≥ 2.5 meters per second AND a NT-proBNP ≥ 160 pg/mL, and that the 12-month mortality rate is 7.9% in this group as compared to 0.5% in patients with normal TRV or NT-proBNP values, with a risk ratio for hospitalization of 1.6. This suggests that a simple screening profile of TRV and NT-proBNP can identify about 20% of patients with SCD at the highest risk of death and hospitalization.
Given the increased mortality and early loss of functional capacity associated with cardiovascular disease in SCD adults, it is important to test effective therapeutic interventions in such patients. Red blood cell transfusions are administered by either simple or exchange transfusion, the latter removes the patients blood and replaces it with transfused red blood cells. Exchange transfusions have proven effective for acute treatment of almost all SCD complications, including severe acute chest syndrome, stroke, splenic or hepatic sequestration, and multi-organ failure, and are also used chronically for stroke prevention and recurrent acute chest syndrome. In this study the investigators hypothesize that monthly exchange transfusion will limit disease progression, improve exercise capacity, and prevent interval episodes of vaso-occlusive painful crisis and the acute chest syndrome that acutely increases pulmonary pressures and cause right heart failure.
The investigators propose to perform a clinical trial to evaluate the effects of automated exchange blood transfusion on patient morbidity and mortality, compared to standard of care among 150 adult high risk SCD patients. The trial will leverage existing coordinating center infrastructure at the University of Pittsburgh and will involve 22 experienced clinical sites. Despite the safety and wide utilization of erythrocytapheresis in adult patients with SCD, there is no consensus or quality efficacy data on its use to improve outcomes in our aging high-risk SCD patients with progressive end-organ dysfunction.
- Conditions
- Sickle Cell Disease
- Being tested
- Red Blood Cell, Standard of care
- Medical subject headings
- Anemia, Sickle Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Red Blood CellBiological
Also called Red blood cell (RBC)
Red blood cell exchange transfusions will be performed every 3-6 weeks to maintain a target post-transfusion hemoglobin S level of <20% and a pre-transfusion hemoglobin S of <30%.
Standard of careOther
NHLBI/ASH/ATS Expert Panel recommended guidelines
| Study group | Role | What they receive |
|---|---|---|
| Exchange transfusion plus standard of care | Experimental | Randomized to standard of care and automated exchange blood transfusion every 3-6 weeks for 12 months. Receives: Biological: Red Blood Cell; Other: Standard of care |
| Standard of care | Active comparator | Randomized to standard of care Receives: Other: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Episodes of clinical worsening
The efficacy of the intervention will be measured by comparing the total number of episodes of clinical worsening of SCD requiring acute health care encounters (non-elective infusion center/ER/Hospital visits) or resulting in death over 13 months between groups.
Measured: 13 months
Secondary outcomes (17)
Acute healthcare event
A 6-level prioritized rank-based outcome: 1.No death or SCD-related acute health care encounters (SCDAcuteE) within (w/in) 13 months (m) of randomization; 2. Had SCDAcuteE but NO major complications (acute kidney injury (AKI), acute chest syndrome (ACS), cor pulmonale, stroke, liver failure) associated with an SCDAcuteE nor death w/in 13 m of randomization; 3. Had 1 major complication (AKI, ACS, cor pulmonale, stroke, or liver failure) associated with an SCDAcuteE but not death w/in 13 m of randomization; 4. Had 2 major complications (AKI, ACS, cor pulmonale, stroke, or liver failure) associated with SCDAcuteE but not death w/in 13 m of randomization; 5. Had ≥ 3 major complications (AKI, ACS, cor pulmonale, stroke, or liver failure) associated with SCDAcuteE but not death w/in 13 m of randomization; 6.Death w/in 13 m of randomization. If the same complication reoccurs, occurrences will be counted as separate complications if the acute health care encounters are separated by ≥7 days.
Measured: 13 months
Twelve-month survival
Survival over thirteen-month period will be analyzed and compared between the group receiving the intervention and the group receiving care routinely provided for sickle cell patients based on the NHLBI guidelines.
Measured: 13 months
Survival free of acute healthcare encounters
Survival free of acute health care encounters over 13 months.
Measured: 13 months
Total number of acute health care encounters
The total number of acute health care encounters (non-elective infusion center/ER/Hospital visits) with evidence of cor pulmonale (physical exam findings, NT-proBNP increase plus echocardiographic evidence of worsening right heart function).
Measured: 13 months
Measures of exercise capacity - 6 minute walk distance
Measures of exercise capacity assessed at 4, 8 and 12 months by the distance walked in the six minute walk distance assessment
Measured: 4, 8, and 12 months
Measures of exercise capacity - outpatient activity
Measures of exercise capacity assessed at 4, 8 and 12 months by the distance walked in a 7 day in the outpatient setting.
Measured: 4, 8, and 12 months
Cardiovascular risk
Established cardiovascular risk biomarkers and indices are combined to help the investigators form an opinion about cardiovascular risks. The following will be measured: NT-proBNP, QT prolongation, systemic pulse pressure, albuminuria, estimated GFR and CKD progression Kidney Disease Improving Global Outcomes (KDIGO) CKD Work Group criteria.
Measured: 12 months
Development of new leg ulcers
Participants will be assessed for development of new leg ulcers at each physical exam.
Measured: 4, 8 and 12 months
Measures of exercise capacity - WHO Classification
WHO functional status severity will be measured assessing by looking at limitation of usual physical activity from I (no limitation in usual physical activity) to Class IV (inability to perform any physical activity at rest)
Measured: 4, 8 and 12 months
Nocturnal desaturation
Nocturnal desaturation will measured using a wearable device to measure blood oxygen saturation for 7 nights at home.
Measured: 4, 8 and 12 months
SCD specific patient reported outcomes - Pain
SCD specific patient reported outcomes as measured by self-reported pain
Measured: 4, 8 and 12 months
SCD specific patient reported outcomes -Quality of Life modified PROMIS scale
SCD specific patient reported outcomes as measured by a modified version of health related quality of life questionnaire from PROMIS QoL measure
Measured: 4, 8 and 12 months
SCD specific patient reported outcomes -Quality of Life modified ASCQ-Me scale
SCD specific patient reported outcomes as measured by a modified version of health related quality of life questionnaire from ASCQ-Me QoL measure
Measured: 4, 8 and 12 months
Cardiovascular function by echocardiography - TRV
Cardiovascular function measures from echocardiography assessed at 4, 8 and 12 months: echocardiographic measures of tricuspid regurgitant jet velocity in m/s.
Measured: 4, 8 and 12 months
Cardiovascular function by echocardiography - diastolic left heart function
Diastolic left heart function measured by E/A ratio, E/Em ratio, and deceleration times will be assessed by echocardiography.
Measured: 4, 8 and 12 months
Cardiovascular function by echocardiography - systolic right heart function
Systolic right heart health will be measured by assessing tricuspid annular plane systolic excursion (TAPSE), right ventricular size and contractility from echocardiography of the heart.
Measured: 4, 8 and 12 months
Total number of acute health care encounters
The number of acute health care encounters (non-elective infusion center/ER/Hospital visits) with at least one major complication.
Measured: 13 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2019
- Study start26 Feb 2020
- Primary completion11 May 2026
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Sickle Cell DiseaseStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 173 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Mark Gladwin, University of Maryland, Baltimore
- Investigators
- Mark Gladwin, MD, Study chair, University of MarylandDarrell Triulzi, MD, Principal investigator, University of PittsburghMaria Brooks, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04084080
- Sponsor's protocol ID
- STUDY20110362
- Other IDs
- UG3HL143192
- Acronym
- SCD-CARRE
- Status last verified
- Aug 2026
- First submitted
- 26 Aug 2019
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Results from research conducted under this project will be shared in several ways. Manuscripts will be submitted for publication in high-quality peer-reviewed journals, following the NIH Public Access Policy guidelines. Findings will be presented at relevant national conferences, public lectures, scientific institutions and meetings. The timeline for participant recruitment, data collection and analysis will foster publication, facilitated by the investigators' Publications Committee, of critically important and clinically relevant data throughout the trial. The study datasets will be archived and made available to qualified individuals after a period of exclusive use by the SCD-CARRE trial research team and after publication of the primary manuscripts, following NIH guidelines.
Publications
Bertolet M, Triulzi DJ, Campbell-Lee S, Gordeuk VR, Herbert BM, Novelli E, Jonassaint C, Villanueva F, Chien N, Gladwin MT, Brooks MM; SCD-CARRE Investigators. Design, rationale, and baseline patient characteristics for the Sickle Cell Disease and CardiovAscular Risk-Red cell Exchange (SCD-CARRE) trial. Am Heart J. 2026 Jul 15;301:107542. doi: 10.1016/j.ahj.2026.107542. Online ahead of print.
PubMed 42456844Abbasi M, Srivastava A, Saraf SL. Management of Kidney Disease with Sickle Cell Disease. J Am Soc Nephrol. 2025 Oct 1;36(10):2041-2054. doi: 10.1681/ASN.0000000804. Epub 2025 Jun 26.
PubMed 40569673
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sickle Cell Disease and CardiovAscular Risk - Red Cell Exchange Trial (SCD-CARRE)
- ClinicalTrials.gov ID
- NCT04084080
- Acronym / sponsor ID
- SCD-CARRE / STUDY20110362
- Conditions
- Sickle Cell Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 173 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 26 Feb 2020 (actual)
- Primary completion
- 11 May 2026 (actual)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 10 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The SCD-CARRE trial is a Phase 3, prospective, randomized, multicenter, controlled, parallel two-arm study aimed to determine if automated exchange blood transfusion and standard of care administered to high mortality risk adult SCD patients reduces the total number of episodes of clinical worsening of SCD requiring acute health care encounters (non-elective infusion center/ER/hospital visits) or resulting in death over 12 months as compared with standard of care.
Detailed description
As patients with sickle cell disease (SCD) live to adulthood, the chronic impact of sustained hemolytic anemia and episodic vaso-occlusive events take their toll, with the progressive development of cardiopulmonary organ dysfunction. This culminates in the development of pulmonary hypertension, left ventricular diastolic heart disease, dysrhythmia, chronic kidney disease and sudden death, all major cardiovascular complications of SCD for which there are no approved or consensus therapies. The risk of having pulmonary hypertension and diastolic heart disease can be non-invasively assessed by laboratory tests (NT-proBNP) and Doppler-echocardiography (estimated pulmonary artery systolic pressure). A recent meta-analysis of approximately 6000 patients with SCD demonstrated that patients with elevated tricuspid regurgitant jet velocity (TRV), which is an Doppler-echocardiographic measurement that estimates the pulmonary artery systolic pressure, walked an estimated 30.4 meters less in a 6 minute walk test than those without elevated TRV, and elevated TRV was associated with high mortality (hazard ratio of 4.9). In two large registry cohorts of adult patients with SCD, the investigators found that approximately 20% of the adult SCD population have high values for both biomarkers, defined as a TRV ≥ 2.5 meters per second AND a NT-proBNP ≥ 160 pg/mL, and that the 12-month mortality rate is 7.9% in this group as compared to 0.5% in patients with normal TRV or NT-proBNP values, with a risk ratio for hospitalization of 1.6. This suggests that a simple screening profile of TRV and NT-proBNP can identify about 20% of patients with SCD at the highest risk of death and hospitalization.
Given the increased mortality and early loss of functional capacity associated with cardiovascular disease in SCD adults, it is important to test effective therapeutic interventions in such patients. Red blood cell transfusions are administered by either simple or exchange transfusion, the latter removes the patients blood and replaces it with transfused red blood cells. Exchange transfusions have proven effective for acute treatment of almost all SCD complications, including severe acute chest syndrome, stroke, splenic or hepatic sequestration, and multi-organ failure, and are also used chronically for stroke prevention and recurrent acute chest syndrome. In this study the investigators hypothesize that monthly exchange transfusion will limit disease progression, improve exercise capacity, and prevent interval episodes of vaso-occlusive painful crisis and the acute chest syndrome that acutely increases pulmonary pressures and cause right heart failure.
The investigators propose to perform a clinical trial to evaluate the effects of automated exchange blood transfusion on patient morbidity and mortality, compared to standard of care among 150 adult high risk SCD patients. The trial will leverage existing coordinating center infrastructure at the University of Pittsburgh and will involve 22 experienced clinical sites. Despite the safety and wide utilization of erythrocytapheresis in adult patients with SCD, there is no consensus or quality efficacy data on its use to improve outcomes in our aging high-risk SCD patients with progressive end-organ dysfunction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exchange transfusion plus standard of care | Experimental | Biological: Red Blood Cell, Other: Standard of careRandomized to standard of care and automated exchange blood transfusion every 3-6 weeks for 12 months. |
| Standard of care | Active comparator | Other: Standard of careRandomized to standard of care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age 18 years or older
- Diagnosis of SCD: homozygous sickle cell disease, hemoglobin-SC, Sβ-thalassemia, hemoglobin-SO or hemoglobin-SD.
- Patients not on a chronic exchange transfusion program for at least 60 days.
- If patients are on a SCD drug (e.g. hydroxyurea, glutamine, or P-selectin inhibitors), the doses must be stable for at least 60 days prior to randomization. At the time of randomization, participants must be off Oxbryta for at least 30 days.
- Any one of the following vasculopathy biomarker clinical results (a, b, c, d or e) measured in the last 24 months before randomization that indicates a high-risk patient:
Key exclusion criteria (8 listed)
- RBC alloimmunization resulting in inability of blood bank to obtain compatible components for chronic exchange transfusions
- Previous history of hyper-hemolysis syndrome
- 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.
- Religious objection to receiving blood transfusion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Red Blood CellAlso: Red blood cell (RBC)Red blood cell exchange transfusions will be performed every 3-6 weeks to maintain a target post-transfusion hemoglobin S level of <20% and a pre-transfusion hemoglobin S of <30%. | Biological | Exchange transfusion plus standard of care |
| Standard of careNHLBI/ASH/ATS Expert Panel recommended guidelines | Other | Exchange transfusion plus standard of care, Standard of care |
Primary outcome
Episodes of clinical worsening
Time frame: 13 months
The efficacy of the intervention will be measured by comparing the total number of episodes of clinical worsening of SCD requiring acute health care encounters (non-elective infusion center/ER/Hospital visits) or resulting in death over 13 months between groups.
17 secondary outcomes
Acute healthcare event
Time frame: 13 months
Twelve-month survival
Time frame: 13 months
Survival free of acute healthcare encounters
Time frame: 13 months
Total number of acute health care encounters
Time frame: 13 months
Measures of exercise capacity - 6 minute walk distance
Time frame: 4, 8, and 12 months
Measures of exercise capacity - outpatient activity
Time frame: 4, 8, and 12 months
Cardiovascular risk
Time frame: 12 months
Development of new leg ulcers
Time frame: 4, 8 and 12 months
Measures of exercise capacity - WHO Classification
Time frame: 4, 8 and 12 months
Nocturnal desaturation
Time frame: 4, 8 and 12 months
SCD specific patient reported outcomes - Pain
Time frame: 4, 8 and 12 months
SCD specific patient reported outcomes -Quality of Life modified PROMIS scale
Time frame: 4, 8 and 12 months
SCD specific patient reported outcomes -Quality of Life modified ASCQ-Me scale
Time frame: 4, 8 and 12 months
Cardiovascular function by echocardiography - TRV
Time frame: 4, 8 and 12 months
Cardiovascular function by echocardiography - diastolic left heart function
Time frame: 4, 8 and 12 months
Cardiovascular function by echocardiography - systolic right heart function
Time frame: 4, 8 and 12 months
Total number of acute health care encounters
Time frame: 13 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
- Derived from this study: PubMed 42456844Bertolet M, Triulzi DJ, Campbell-Lee S, Gordeuk VR, Herbert BM, Novelli E, Jonassaint C, Villanueva F, Chien N, Gladwin MT, Brooks MM; SCD-CARRE Investigators. Design, rationale, and baseline patient characteristics for the Sickle Cell Disease and CardiovAscular Risk-Red cell Exchange (SCD-CARRE) trial. Am Heart J. 2026 Jul 15;301:107542. doi: 10.1016/j.ahj.2026.107542. Online ahead of print.
- Derived from this study: PubMed 40569673Abbasi M, Srivastava A, Saraf SL. Management of Kidney Disease with Sickle Cell Disease. J Am Soc Nephrol. 2025 Oct 1;36(10):2041-2054. doi: 10.1681/ASN.0000000804. Epub 2025 Jun 26.
- Individual participant dataSharing planned: Yes. Results from research conducted under this project will be shared in several ways. Manuscripts will be submitted for publication in high-quality peer-reviewed journals, following the NIH Public Access Policy guidelines. Findings will be presented at relevant national conferences, public lectures, scientific institutions and meetings. The timeline for participant recruitment, data collection and analysis will foster publication, facilitated by the investigators' Publications Committee, of critically important and clinically relevant data throughout the trial. The study datasets will be archived and made available to qualified individuals after a period of exclusive use by the SCD-CARRE trial research team and after publication of the primary manuscripts, following NIH guidelines.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Gladwin, MD study chair
University of Maryland
Darrell Triulzi, MD principal investigator
University of Pittsburgh
Maria Brooks, PhD principal investigator
University of Pittsburgh
23 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Red Blood Cell in people with Sickle Cell Disease, run by University of Pittsburgh at 23 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in United States, France, Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Episodes of clinical worsening (time frame: 13 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04084080, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2026.