INTERCEPT Treated RBCs for Anemia

(ReCePI Trial)

Recruiting at 17 trial locations

Overseen By Paulette Niemyski

Age: Any Age

Sex: Any

Trial Phase: Phase 3

Sponsor: Cerus Corporation

Must be taking: Aspirin, Clopidogrel, GPIIb/IIIa inhibitors

Must not be taking: Dapsone, Levodopa, Methyldopa, others

Disqualifiers: Pregnancy, Autoimmune hemolytic anemia, Kidney disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: 7 days

321 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a special type of blood transfusion for patients having complex heart surgery. The new treatment aims to make blood transfusions safer by reducing infections and complications. The study will evaluate if this new method works effectively.

Research Team

Richard J Benjamin, MD

Principal Investigator

Cerus Corporation

Eligibility Criteria

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.

Inclusion Criteria

I have had a Batista procedure.

Signed and dated informed consent/assent form

I have had or need a single valve repair or replacement surgery.

Exclusion Criteria

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

Up to 30 days

1 visit (in-person)

Treatment

Participants receive RBC transfusions during the acute transfusion support period

7 days

Daily monitoring (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

28 days after last study transfusion

Weekly telephone surveillance calls

Extended Follow-up

Assessment of mortality and RRT status, and collection of serological samples

75 days after last study transfusion

1 visit (in-person or offsite)

Treatment Details

Interventions

• Control
• INTERCEPT Blood System for RBCs

Trial Overview 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.

Participant Groups

Group I: INTERCEPT (test) Experimental Treatment 1 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 Control 1 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.

Who Is Running the Clinical Trial?

Cerus Corporation

Lead Sponsor

Trials

20

Recruited

4,800+