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Trial Outcomes & Findings for An In Vivo 24-Hour Recovery Study of Whole Blood by the Reveos System (NCT NCT05239455)

NCT ID: NCT05239455

Last Updated: 2025-01-08

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

37 participants

Primary outcome timeframe

43 days

Results posted on

2025-01-08

Participant Flow

A donor is considered an "enrolled" participant upon giving informed consent for study participation; this timepoint represents the beginning of a participant's involvement in the study.

37 participants signed consent and there were 4 screen fails.

Participant milestones

Participant milestones
Measure
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. 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.
Overall Study
STARTED
33
Overall Study
COMPLETED
26
Overall Study
NOT COMPLETED
7

Reasons for withdrawal

Reasons for withdrawal
Measure
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. 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.
Overall Study
Adverse Event
1
Overall Study
Sponsor Decision
5
Overall Study
Incomplete Blood Collection
1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Healthy Adult Participants
n=33 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. 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.
Age, Categorical
<=18 years
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
31 Participants
n=5 Participants
Age, Categorical
>=65 years
2 Participants
n=5 Participants
Age, Continuous
41.6 years
STANDARD_DEVIATION 17.52 • n=5 Participants
Sex: Female, Male
Female
17 Participants
n=5 Participants
Sex: Female, Male
Male
16 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
3 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
30 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
Race (NIH/OMB)
Asian
2 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
1 Participants
n=5 Participants
Race (NIH/OMB)
White
28 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
2 Participants
n=5 Participants
Region of Enrollment
United States
33 participants
n=5 Participants
Height
69.15 inches
STANDARD_DEVIATION 4.617 • n=5 Participants
Weight
192.6 lbs
STANDARD_DEVIATION 37.47 • n=5 Participants

PRIMARY outcome

Timeframe: 43 days

Population: The Evaluable Analysis Population includes all participants who completed all study visits per the CIP with a valid 24-hour recovery endpoint.

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

Outcome measures

Outcome measures
Measure
Healthy Adult Participants
n=26 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. 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.
Number of Participants With Success of RBC's in Vivo Recovery After 42-day Storage
23 Participants

PRIMARY outcome

Timeframe: 43 days

Population: The Evaluable Analysis Population includes all participants who completed all study visits per the CIP with a valid 24-hour recovery endpoint.

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

Outcome measures

Outcome measures
Measure
Healthy Adult Participants
n=26 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. 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.
Mean 24-hour, Post-transfusion, in Vivo RBC Recovery Percentage After 42-day Storage
83 % 24-hr RBC Recovery
Standard Deviation 9

Adverse Events

Healthy Adult Participants

Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
Healthy Adult Participants
n=33 participants at risk
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. 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.
General disorders
Vessel puncture site bruise
6.1%
2/33 • Adverse event data were collected from the time of signing the informed consent through study completion. Adverse event assessments occurred at Day 0, Day 42, and Day 43. There was no long term follow-up.
Only procedure emergent AEs (PEAEs) were included in the safety evaluation. Collection of PEAEs began at the time of the first exposure to Reveos Blood Bag set and continued throughout the entire study until study exit or observed related AEs were resolved. Starting with the first baseline procedure, any new event/experience that was not present at baseline, or worsening of an event present at baseline, was considered an AE.

Additional Information

Erin Goodhue, DO, MPH, Director, Clinical Affairs

Terumo BCT, Inc

Phone: 614-400-4638

Results disclosure agreements

  • Principal investigator is a sponsor employee Available upon request.
  • Publication restrictions are in place

Restriction type: OTHER