An In Vivo 24-Hour Recovery Study of Whole Blood by the Reveos System

NCT ID: NCT05239455

Last Updated: 2025-01-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-11
• Study Completion Date: 2022-04-30

Brief Summary

This is an in vivo 24-hour recovery study of leukoreduced red blood cells (RBCs) after automated separation of whole blood by the Reveos Automated Blood Processing System and storage for 42 days.

Detailed Description

The Reveos® Automated Blood Processing System (Reveos system) is an automated whole blood processing system, not cleared for use in the United States. The Reveos System has been available outside the United States since 2012 and is seeking United States Food and Drug Administration (FDA) 510(k) clearance as an automated whole blood processor. The Reveos System is an integrated manufacturing system that processes whole blood (WB) units into blood components and is designed to minimize manual blood processing variables resulting from processing time, product and procedural variability. The Reveos System can simultaneously process up to 4 whole blood units into 4 RBC units, 4 leukoreduced plasma units, and 4 interim platelet units (IPU). The CPD/AS-5 RBC product is leukoreduced and may be stored up to 42 days.

Terumo BCT is seeking 510(k) clearance from FDA/CBER for the Reveos® Automated Blood Processing System (Reveos System). The proposed study will provide validation on the in vivo performance of LR-RBC units derived from WB processed with the Reveos System. The results will provide data as to whether the Reveos System produced LR-RBC can maintain required levels of 24-hour in vivo recovery that meet FDA criteria for RBC.

Conditions

Device Validation of In-vivo Performance

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Healthy adult participants

Performance criteria will be evaluated in healthy adult participants, who receive radiolabeled, autologous infusions of LR-RBC components after being stored for 42 days at 1-6°C.

Group Type: EXPERIMENTAL

Reveos® Automated Blood Processing System

Intervention Type: DEVICE

This is a non-interventional study, observing the in vivo performance of LR-RBC units derived from WB processed with the Reveos System.

Interventions

Reveos® Automated Blood Processing System

This is a non-interventional study, observing the in vivo performance of LR-RBC units derived from WB processed with the Reveos System.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Healthy volunteers, of either gender

2. Age 18 years or older.

3. Normal health status as per AABB criteria for healthy donor.

4. Able to commit to the study schedule.

6. Participants of childbearing potential (either male or female) must agree to use medically acceptable method of contraception throughout of the study.

7. Females of childbearing potential must be willing to take a pregnancy test prior to WB donation and infusion of radiolabeled RBCs.

8. Signed and dated informed consent form.

Exclusion Criteria

1. Pregnant or nursing females.

2. Serum ferritin <12 ng/mL

3. Has previously completed this study with evaluable data points.

4. Participation currently, or within the past 30 days, in another investigational trial that would potentially interfere with the analysis of this investigation (eg, pharmaceutical).

5. As determined by the Investigator

1. Has been diagnosed with a blood disorder(s) affecting RBC characteristics (eg, G- 6PD).

2. Reported history of RBC autoantibodies/autoimmune hemolytic anemia, RBC alloantibodies.

3. Clinically significant acute or chronic disease

4. Reported history of known hypersensitivity to technetium or chromium.

5. Treatment with any medication as specified in site deferral list (based on AABB medication deferral list for blood donors).

6. Other unspecified reasons that, in the opinion of the investigator make the subject unsuitable for enrollment.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Terumo BCT

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jose A Cancelas, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hoxworth Blood Center, University of Cincinnati

Moritz Stolla, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Bloodworks Northwest Research Institute

James Kelley, MD, PhD

Role: STUDY_CHAIR

Terumo BCT

Locations

Hoxworth Blood Center, University of Cincinnati

Cincinnati, Ohio, United States

Bloodworks Northwest Research Institute

Seattle, Washington, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

CTS-5085

Identifier Type: -

Identifier Source: org_study_id