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

NCT05239455 | Completed Results FDA Device

• 1 other identifier: CTS-5085
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 2

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.

Conditions

Device Validation of In-vivo Performance

Keywords

Reveos; Reveos Device; Reveos System; Red Blood Cell Storage; Whole Blood Processing; In-vivo 24-hour red blood cell recovery; Reveos System Manager; Reveos SELECT Set US; Reveos In Vivo US

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Success of RBC's in Vivo Recovery After 42-day Storage

  The primary outcome of this study is to measure mean 24-hour, post-transfusion, in vivo RBC recovery percentage after LR-RBCs derived from WB and processed with the Reveos System have been stored for 42-days at 1-6°C. The 3 parts of FDA's RBC recovery criteria that must be met (below) are presented in Primary Outcome 1 and Primary Outcome 2. The derivation of the sample size was based on the level of precision attained with 24 subjects relative to the 1st part of the criteria. 1. The one-sided 95% lower confidence limit for the population proportion of success is greater than 70% where success of a unit is defined as the RBC in vivo 24-hour percentage recovery ≥ 75% \[Allows for low recoveries (\<75%) in 2/20 or 3/24 volunteers\] - Primary Outcome 1 2. The sample mean of percent recovery ≥ 75% - Primary Outcome 2 3. The sample standard deviation of in vivo 24-hour RBC recovery ≤ 9% - Primary Outcome 2

  43 days

• Mean 24-hour, Post-transfusion, in Vivo RBC Recovery Percentage After 42-day Storage

  The primary outcome of this study is to measure mean 24-hour, post-transfusion, in vivo RBC recovery percentage after LR-RBCs derived from WB and processed with the Reveos System have been stored for 42-days at 1-6°C. The 3 parts of FDA's RBC recovery criteria that must be met (below) are presented in Primary Outcome 1 and Primary Outcome 2. The derivation of the sample size was based on the level of precision attained with 24 subjects relative to the 1st part of the criteria. 1. The one-sided 95% lower confidence limit for the population proportion of success is greater than 70% where success of a unit is defined as the RBC in vivo 24-hour percentage recovery ≥ 75% \[Allows for low recoveries (\<75%) in 2/20 or 3/24 volunteers\] - Primary Outcome 1 2. The sample mean of percent recovery ≥ 75% - Primary Outcome 2 3. The sample standard deviation of in vivo 24-hour RBC recovery ≤ 9% - Primary Outcome 2

  43 days

Study Arms (1)

Healthy adult participants

EXPERIMENTAL

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.

Device: Reveos® Automated Blood Processing System

Interventions

Reveos® Automated Blood Processing System DEVICE

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

Healthy adult participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy volunteers, of either gender
• Age 18 years or older.
• Normal health status as per AABB criteria for healthy donor.
• Able to commit to the study schedule.
• Participants of childbearing potential (either male or female) must agree to use medically acceptable method of contraception throughout of the study.
• Females of childbearing potential must be willing to take a pregnancy test prior to WB donation and infusion of radiolabeled RBCs.
• Signed and dated informed consent form.

You may not qualify if:

• Pregnant or nursing females.
• Serum ferritin \<12 ng/mL
• Has previously completed this study with evaluable data points.
• Participation currently, or within the past 30 days, in another investigational trial that would potentially interfere with the analysis of this investigation (eg, pharmaceutical).
• As determined by the Investigator
• Has been diagnosed with a blood disorder(s) affecting RBC characteristics (eg, G- 6PD).
• Reported history of RBC autoantibodies/autoimmune hemolytic anemia, RBC alloantibodies.
• Clinically significant acute or chronic disease
• Reported history of known hypersensitivity to technetium or chromium.
• Treatment with any medication as specified in site deferral list (based on AABB medication deferral list for blood donors).
• Other unspecified reasons that, in the opinion of the investigator make the subject unsuitable for enrollment.

Sponsors & Collaborators

• Terumo BCT: lead

Study Sites (2)

Hoxworth Blood Center, University of Cincinnati

Cincinnati, Ohio, 45267, United States

Location

Bloodworks Northwest Research Institute

Seattle, Washington, 98102, United States

Location

Results Point of Contact

• Title: Erin Goodhue, DO, MPH, Director, Clinical Affairs
• Organization: Terumo BCT, Inc

Erin.Goodhue@TerumoBCT.com

614-400-4638

Study Officials

• Jose A Cancelas, MD, PhD

  Hoxworth Blood Center, University of Cincinnati

  PRINCIPAL INVESTIGATOR

• Moritz Stolla, MD, PhD

  Bloodworks Northwest Research Institute

  PRINCIPAL INVESTIGATOR

• James Kelley, MD, PhD

  Terumo BCT

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2022
• First Posted: February 14, 2022
• Study Start: November 11, 2021
• Primary Completion: April 30, 2022
• Study Completion: April 30, 2022
• Last Updated: January 8, 2025
• Results First Posted: January 8, 2025

Record last verified: 2023-04

Locations

US (2)