Red Blood Cell Exchange for Sickle Cell Disease
(SCD-CARRE Trial)
Recruiting in Palo Alto (17 mi)
+22 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: University of Pittsburgh
Disqualifiers: RBC alloimmunization, Hyper-hemolysis, Severe transfusion reaction, others
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Approved in 2 jurisdictions
Trial Summary
What is the purpose of this trial?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.
Do I need to stop taking my current medications for the trial?
If you are on a sickle cell disease drug like hydroxyurea, glutamine, or P-selectin inhibitors, your doses must be stable for at least 60 days before joining the trial. You must stop taking Oxbryta at least 30 days before starting the trial.
What data supports the effectiveness of the treatment Automated Exchange Blood Transfusion for Sickle Cell Disease?
Research shows that automated red blood cell exchange can effectively manage acute complications in sickle cell disease by improving anemia and oxygen delivery while reducing sickle cells in the blood. It has been successful in preventing strokes and improving quality of life in patients, although it requires specialized resources and can have challenges like venous access issues.
12345Is red blood cell exchange safe for humans?
Research shows that red blood cell exchange, whether done manually or automatically, is generally safe for people with sickle cell disease. Studies have found no complications related to the procedure over several years, and it can even reduce the risk of infections from blood transfusions.
26789How is automated red blood cell exchange different from other treatments for sickle cell disease?
Automated red blood cell exchange is unique because it quickly reduces the number of sickle-shaped red blood cells and improves oxygen delivery to tissues, which can help manage acute complications of sickle cell disease. Unlike manual methods, it is more efficient and requires less time, but it may not be available 24/7 in all centers.
12345Eligibility Criteria
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.Inclusion Criteria
Written informed consent obtained from patient to participate in the trial.
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.
+9 more
Exclusion 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.
You have had a condition called hyper-hemolysis syndrome in the past.
+5 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive either standard of care or automated exchange blood transfusion every 3-6 weeks for 12 months
12 months
Monthly visits for transfusion
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
2 visits (in-person)
Long-term monitoring
Participants are assessed for survival and acute healthcare encounters over 13 months
13 months
Participant Groups
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.
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
Automated Exchange Blood Transfusion is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as Red Cell Exchange for:
- Acute chest syndrome
- Stroke
- Multi-organ failure syndromes
- Right upper quadrant syndrome
- Priapism
- Chronic management of sickle cell disease
🇪🇺 Approved in European Union as Red Cell Exchange for:
- Acute chest syndrome
- Stroke
- Multi-organ failure syndromes
- Right upper quadrant syndrome
- Priapism
- Chronic management of sickle cell disease
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of North Carolina at Chapel HillChapel Hill, NC
Howard University Center for Sickle Cell DiseaseWashington, United States
Icahn School of Medicine at Mount SinaiNew York, NY
University of AlabamaTuscaloosa, AL
More Trial Locations
Loading ...
Who Is Running the Clinical Trial?
University of PittsburghLead Sponsor
Mark GladwinLead Sponsor
Gladwin, Mark, MDLead Sponsor
National Heart, Lung, and Blood Institute (NHLBI)Collaborator
References
Erythrocytapheresis (red cell exchange). [2004]Automated erythrocytapheresis (red cell exchange) was performed on two patients with sickle cell disease using the IBM 2997 Blood Cell Separator. Preoperative red cell exchange was performed on patient L.N. to prevent possible anterior ischemic syndrome during surgery. A red cell exchange procedure on patient A.Y. diminished her acute sickle crisis symptoms and resolved respiratory complications. For each patient, the instrument settings were varied in order to achieve the desired effect for the hematological needs of the individual patient.
Partial Red Blood Cell Exchange in Children and Young Patients with Sickle Cell Disease: Manual Versus Automated Procedure. [2018]The benefits of manual versus automated red blood cell exchange have rarely been documented and studies in young sickle cell disease patients are scarce. We aim to describe and compare our experience in these two procedures.
[Advantages and difficulties of an erythrocytapheresis program for sickle-cell patients: a pediatric experience]. [2012]Transfusion programs are sometimes necessary to take care of severe sickle-cell patients. Treatment of cerebrovascular disease in sickle-cell disease is the most common indication. Periodic automated red blood cell exchange (erythrocytapheresis) is an alternative treatment. Sixteen patients less than 20 years old have been treated with chronic erythrocytapheresis since 2004 in the pediatric hematology and oncology department of the University Hospital of Rouen, 10 patients for cerebrovascular disease (1 was on secondary prevention and 9 were on primary prevention), 5 patients for pain crisis recurrence, and the last one for mild psychocognitive deficit disorder. This treatment was unsuccessful for 4 patients, 3 on primary prevention and 1 treated for pain crisis recurrence. These failures were caused by alloimmunization for 2 patients and venous access problems for 2 patients. For the other 12 patients, 5 of the 6 patients on primary prevention showed clear improvement (normalization of transcranial Doppler ultrasound or improvement on magnetic resonance angiography), the patient on secondary prevention had stability on cerebral MRI after 2 years of treatment, the 5 patients with pain crisis recurrence had good improvement, and psychocognitive abilities improved for the last patient. One hundred and ninety-nine erythroexchange sessions were performed for the 9 patients treated over a period of 10 to 30 months. Erythrocytapheresis sessions ran on average less than 1.5h. Three patients showed high ferritin levels at the beginning of erythroexchange, which normalized 2 to 10 months later. All patients reported better quality of life. Periodic erythroexchanges are an effective treatment for complicated sickle-cell anemia and iron overload. It requires human, material, and financial support, but not as much as simple transfusion or manual erythroexchange. Practical experience shows problems of venous access because of coagulation when sampling.
Comparison of automated erythrocytapheresis versus manual exchange transfusion to treat cerebral macrovasculopathy in sickle cell anemia. [2018]Chronic exchange transfusion is effective for primary and secondary prevention of stroke in children with sickle cell anemia (SCA). Erythrocytapheresis is recognized to be the most efficient approach; however, it is not widely implemented and is not suitable for all patients. The aim of our study was to compare automated exchange transfusion (AET) with our manual method of exchange transfusion and, in particular, to evaluate the efficacy, safety, and cost of our manual method.
Emergency red cell exchange for the management of acute complications in sickle cell disease: Automated versus manual. [2023]Red blood cell exchange is the cornerstone of the management for acute complications of sickle cell disease. It improves anaemia and improvesperipheral tissue oxygen delivery while at the same time reduces the proportion of circulating sickle erythrocytes. Even though automated red cell exchange is very effective in rapidly lowering the Hb S level, 24-h availability is currently not feasible for most specialist centres including our own.
Procedural adverse events in pediatric patients with sickle cell disease undergoing chronic automated red cell exchange. [2022]Chronic automated red cell exchange (RCE) is increasingly employed for sickle cell disease (SCD). There is a paucity of data on the incidence of RCE adverse events (AEs) and potential patient and procedural risk factors for AEs.
Efficacy and Safety of Manual Partial Red Cell Exchange in the Management of Severe Complications of Sickle Cell Disease in a Developing Country. [2020]The realization of red cell exchange (RCE) in Africa faces the lack of blood, transfusion safety, and equipment. We evaluated its efficacy and safety in severe complications of sickle cell disease.
Comparative study between chronic automated red blood cell exchange and manual exchange transfusion in patients with sickle cell disease: A single center experience from Saudi Arabia. [2023]Red cell transfusion remains the gold standard in managing sickle cell disease (SCD) with severe complications. Offering red blood cell exchange (RBCX) either manual exchange transfusion (MET) or automated RBCX (aRBCX) can reduce the complications of chronic transfusion and maintain target Hb thresholds. This study audits the hospital experience of overseeing adult SCD patients treated with RBCX, both automated and manual, and compares the safety and efficacy.
Chronic red blood cell exchange to prevent clinical complications in sickle cell disease. [2014]We tracked the results of 394 manual or automatic red blood cell exchanges done with a cell separator in 20 sickle cell patients at high risk for recurrent complications. Over an average of 6 years, none of the patients developed complications related to the procedure or to the increased blood use. It was safe and effective in preventing complications of sickle cell disease, and if done automatically, reduced iron overload. Ferritin levels also decreased in patients treated with automatic red blood cell exchange. Furthermore, using Single Donor Red Blood Cell units (SDRC) we reduced the potential exposure to transfusion transmitted infectious diseases (TTI).