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INTERCEPT Treated RBCs for Anemia (ReCePI Trial)
Phase 3
Waitlist Available
Led By Richard J Benjamin, MD
Research Sponsored by Cerus Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 75 days
Awards & highlights
ReCePI Trial Summary
This trial will compare the effects of transfusing patients with RBCs treated with the INTERCEPT Blood System to those who receive conventional RBC transfusions.
Who is the study for?
This trial is for patients weighing at least 40 kg, aged 11 or older, undergoing complex cardiac surgery such as multiple valve repairs or coronary artery bypass grafts. They must not be pregnant and agree to use reliable birth control if of child-bearing potential. Excluded are those with certain allergies, autoimmune diseases affecting red blood cells, severe kidney or liver issues, recent transfusions or participation in other clinical trials.Check my eligibility
What is being tested?
The study tests the safety and effectiveness of the INTERCEPT Blood System for Red Blood Cells (RBCs) in patients with acute anemia from cardiovascular surgeries. It compares outcomes like renal impairment after receiving INTERCEPT-treated RBCs versus conventional RBC transfusions.See study design
What are the potential side effects?
While specific side effects aren't listed here, generally blood transfusion risks include allergic reactions, fever, iron overload from frequent transfusions over time and rarely infectious disease transmission.
ReCePI Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 75 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~75 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Proportion of patients who have received at least one study transfusion with a diagnosis of renal impairment defined as
Treatment emergent antibodies
Secondary outcome measures
Adverse Events
HLA allo-antigens
Mortality or the need for RRT
+4 moreReCePI Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: INTERCEPT (test)Experimental Treatment1 Intervention
The INTERCEPT treatment process uses amustaline and glutathione together with a processing solution in a single-use disposable set and results in pathogen and leukocyte inactivated RBCs suspended in SAG-M additive solution (INTERCEPT RBCs). The INTERCEPT treatment will be performed on leukocyte reduced RBC components prepared from whole blood collections and suspended in AS-5 additive solution within 24 hours of collection. The test component is allogeneic INTERCEPT RBCs suspended in SAG-M and stored at 1°C to 6 for up to 35 days post-donation and administered intravenously. Dose and schedule of RBC transfusions will be determined by the treating physician.
Group II: Conventional (Control)Active Control1 Intervention
The control transfusion component is a conventional leukocyte-reduced RBC component in an FDA approved additive solution (AS-1, AS-3 or AS-5) stored at 1°C to 6°C for up to 35 days post-donation and administered intravenously. The Control RBC components will be handled and labeled in a manner so as to maintain blinding. Dose and schedule of RBC transfusions will be determined by the treating physician.
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Who is running the clinical trial?
Cerus CorporationLead Sponsor
18 Previous Clinical Trials
4,576 Total Patients Enrolled
3 Trials studying Anemia
881 Patients Enrolled for Anemia
Richard J Benjamin, MDPrincipal InvestigatorCerus Corporation
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had a Batista procedure.I plan to use my own or directed blood donations.I am scheduled for a heart transplant.I needed a heart pump before surgery due to severe heart failure.I have had or need a single valve repair or replacement surgery.I received a blood transfusion in the last week while hospitalized.My liver is not working well and my bilirubin level is high.I have had surgery to fix a heart defect I was born with.I have had surgery to repair a hole in my heart.I have had surgery to repair my heart's ventricle.I have had surgery on my aorta.I have not been in a drug or device study in the last 28 days.I need blood components treated with gamma radiation.You have a known deficiency of IgA or have had severe allergic reactions to blood products in the past.I have had surgery to repair a bulge in my heart's left chamber.I weigh at least 40 kg.My blood test shows I have specific antibodies related to INTERCEPT RBCs.I am not taking medications harmful to red blood cells like dapsone or levodopa.I have an active condition where my immune system attacks my red blood cells.I have kidney disease or injury with a creatinine level of 1.8 mg/dL or higher, or I need dialysis.I have antibodies that could make blood transfusions difficult.I've needed special blood cell treatments due to reactions.My blood test shows I might have an autoimmune reaction.I have had or need multiple valve repair or replacement surgeries.I am 11 years old or older.I am scheduled for a complex heart or major blood vessel surgery.I have had one or more bypass surgeries for my heart.I am having or have had a single vessel coronary artery bypass.I have had or will have surgery for both heart bypass and valve repair.I have had heart surgery, possibly with bypass grafts.I am on blood thinners or have a high risk of needing a blood transfusion.I am a woman able to have children and meet specific health criteria.I've had heart or major chest surgery with a high risk of bleeding.I have or will need heart support with a device before or after surgery.
Research Study Groups:
This trial has the following groups:- Group 1: INTERCEPT (test)
- Group 2: Conventional (Control)
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.
Are a lot of different hospitals participating in this study within the city limits?
"Currently, this trial is enrolling patients at centres including University of California Los Angeles in Los Angeles, California, Mayo-Rochester in Rochester, Minnesota, and Duke University Health System in Durham, North carolina."
Answered by AI
How many people are being signed up to participate in this research project?
"In order to move forward, this study needs 292 individuals that fit the bill in terms of specified inclusion criteria. Clinics in University of California Los Angeles and Mayo-Rochester are two examples of medical centres where patients can take part in this trial."
Answered by AI
Has the INTERCEPT blood safety system received federal approval in the United States?
"There is some efficacy data and multiple rounds of safety data from previous trials, so INTERCEPT received a score of 3."
Answered by AI
Is this a full trial or are there still open positions for volunteers?
"The clinical trial is presently seeking participants, as seen on clinicaltrials.gov. This information was originally posted on December 5th, 2018 and was last edited on March 2nd, 2022."
Answered by AI
What is the goal of this research?
"The primary outcome of this clinical trial will be evaluated over a 48-hour period and pertains to the development of treatment-emergent antibodies. Additionally, secondary outcomes such as SAEs (Treatment-emergent SAEs through 28 days after the last study transfusion), mortality rates, or the need for RRT (renal replacement therapy) will also be monitored."
Answered by AI
Who else is applying?
What state do they live in?
Tennessee
How old are they?
65+
What portion of applicants met pre-screening criteria?
Did not meet criteria
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