Whole Blood Donation and LeukoreductionPhase 2NCT03301779

Clinical Investigation to Evaluate the Hemanext® Oxygen Reduction System - Pivotal Trial

A Phase 2 study testing Hemanext Red Blood Cell Processing System in people with Whole Blood Donation and Leukoreduction, run by Hemanext at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The primary goal of Hemanext. is to improve red cell storage through novel storage methods. Based on our review of the pertinent literature, there is substantial evidence suggesting that prolonged exposure to oxygen during storage results in oxidative damage to the red blood cells leading to decreased therapeutic… Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Whole Blood Donation and Leukoreduction
What is being tested?: Hemanext Red Blood Cell Processing System
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 100 participants
Where: 3 sitesUnited States
Study dates: 27 Nov 2017to 6 Mar 2019
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Study donor must be ≥ 18 years of age.
Study donor must be ≥ 110 pounds.
Study donor's body temperature must be ≤ 37.5°C / 99.5°F (oral).
Study donor's hemoglobin must be ≥12.5 g/dL if female and ≥13.0 g/dL if male.
Study donor's hematocrit must be ≥ 38% if female and ≥39% if male.Study participants must meet EITHER hemoglobin or hematocrit criteria.
Study donor must meet all criteria per respective site's Research Blood Donation Record (BDR).

Show all 15Show fewer

Study donor's most recent single RBC unit donation must have been ≥56 days prior to study donation.
Study donor's most recent double RBC unit donation must have been ≥ 112 days prior to study donation.
Study donor must have consented to study participation by reviewing and having expressed understanding the site-respective IRB-approved informed consent form prior to undergoing any study related procedures.
21 CFR 50
Study donor's testing results from collected blood does not indicate a risk of transfusion-transmitted disease (TTD)*.
Study donors must agree to report adverse events from the time of signing the informed consent to twenty-four hours following the end of their active study involvement.
Female study donors must not be pregnant, expected to be pregnant or breastfeeding.
Female donors who participate in the in vivo portion of the study:
Women of child-bearing age must not be pregnant as determined by a negative pregnancy test prior to each re-infusion. If acceptable by local procedures, post-menopausal or surgically sterile women may be exempt from the pregnancy testing requirement.

Who cannot join

Study donor is < 18 years of age.
Study donor < 110 pounds.
Study donor's body temperature is > 37.5°C / 99.5°F (oral).
Study donor's hemoglobin is < 12.5 g/dL if female and < 13.0 g/dL if male.
Study donor's hematocrit is < 38% if female and < 39% if male.
Study donor does not meet all criteria per respective site's Research Blood Donation Record (BDR).

Show all 11Show fewer

Study donor's most recent single RBC unit donation was < 56 days prior to study donation.
Study donor's most recent double RBC unit donation was < 112 days prior to study donation.
Study donor has not consented to study participation.
Study donor's testing results from collected blood does indicate a risk of transfusion-transmitted disease (TTD)*.
Female donors who participate in the in vivo portion of the study: study donor is pregnant, expected to be pregnant or breastfeeding.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Hoxworth Blood Center, University of Cincinnati
Cincinnati, Ohio, 45267-0055
Blood Center of Wisconsin
Milwaukee, Wisconsin, 53233
American Red Cross Mid-Atlantic Research Facility
Norfolk, Virginia, 23507

Other trials in United States

About this study

Official title: Clinical Investigation to Evaluate the New Health Sciences Hemanext® Oxygen Reduction System for Leukoreduced Red Blood Cells With CP2D Anticoagulant and AS-3 Additive - Pivotal Trial

Currently, Hemanext has focused on the design and development of a dual compartment bag system designated as the Hemanext Red Blood Cell Processing System. After standard processing of donated whole blood units into leukoreduced packed red blood cells (LR-RBCs) with the appropriate additive solutions, the LR-RBCs would then be placed in the oxygen reduction bag (ORB) which allows for the rapid diffusion of oxygen out of the blood, through a sterile, oxygen-permeable membrane, and into iron-based oxygen sorbents. After processing, the blood is transferred again from the ORB into the Hemanext storage bag (HSB) which will preserve the anaerobic state of the LR-RBC product for the duration of cold storage.

Hemanext has conducted preliminary storage tests to ascertain the effects of anaerobic storage on overall blood health in various storage solutions. The research team has focused primarily on percent hemolysis, which is mandated by the FDA to remain below 1% for the duration of storage, as well as ATP and 2,3-DPG levels.

Read the detailed description

In vitro and in vivo performance of O2/CO2 reduced red blood cells produced with the Hemanext System will be used to demonstrate the acceptability the final product for clearance. To accomplish this, the study will require a total of 100 studyevaluable donors. completing the study. The study entails a randomized, paired, 2-x-2 crossover design where every study donor (n = 10093) evaluable study donors who completes the study will donate a total of two whole blood units with individual units being donated at least 56 days (8 weeks) apart. One unit will be used as the test and the other unit will be used for the control. The order in which the IP and the CP will be used to collect, filter and store the whole blood and appropriate blood products (within the context of the crossover design) will be randomized.

Conditions: Whole Blood Donation and Leukoreduction
Being tested: Hemanext Red Blood Cell Processing System
Keywords: Red Blood Cells

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Hemanext Red Blood Cell Processing SystemDevice
Leukoreduced red blood cell product from donors in the Investigational Product arm will be processed in the Hemanext Oxygen Reduction Bag for 3 hours and then transferred to the Hemanext Storage Bag and stored for 42 days at 1-6°C.

Study groups in NCT03301779
Study group	Role	What they receive
Investigational Product	Experimental	Blood product from these donors will be processed and stored using the Hemanext Red Blood Cell Processing System Receives: Device: Hemanext Red Blood Cell Processing System
Control Product	No intervention	Blood product from these donors will be stored in a Haemonetics Leukotrap Whole Blood System.

What is being measured

The primary outcome is the main question the study is designed to answer.

% of Red Blood Cells With Hemolysis
Percentage of packed Red Blood Cell units with hemolysis at day 42 of storage.
Measured: On day 42 of storage
Dual Label 24 Hour In Vivo % Recovery of Red Blood Cells
The mean 24-hour, post-transfusion, in vivo red blood cell recovery.
Measured: Day 42 of storage
% Red Blood Cells Recovered Post-Filtration
Percentage of red blood cells recovered after the filtration process.
Measured: Post-Filtration on Day 0

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 Nov 20176 Mar 2019

First posted4 Oct 2017
Study start27 Nov 2017
Primary completion6 Mar 2019
Study completion6 Mar 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Whole Blood Donation and LeukoreductionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 100 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03301779
Sponsor's protocol ID: CLIN-0001
Status last verified: Jun 2020
First submitted: 25 Sep 2017
Last updated: 23 Jun 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Study at a glance

From the registry record, last updated by the sponsor on 23 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Investigation to Evaluate the New Health Sciences Hemanext® Oxygen Reduction System for Leukoreduced Red Blood Cells With CP2D Anticoagulant and AS-3 Additive - Pivotal Trial
ClinicalTrials.gov ID: NCT03301779
Acronym / sponsor ID: CLIN-0001
Conditions: Whole Blood Donation and Leukoreduction
Keywords: Red Blood Cells
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 100 participants (actual)
Lead sponsor: HemanextIndustry (pharma, biotech, devices)
Study start: 27 Nov 2017 (actual)
Primary completion: 6 Mar 2019 (actual)
Study completion: 6 Mar 2019 (actual)
First posted: 4 Oct 2017 (actual)
Results: Posted 17 Mar 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Investigational Product	Experimental	Device: Hemanext Red Blood Cell Processing SystemBlood product from these donors will be processed and stored using the Hemanext Red Blood Cell Processing System
Control Product	No intervention	–Blood product from these donors will be stored in a Haemonetics Leukotrap Whole Blood System.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (15 listed)

Study donor must be ≥ 18 years of age.
Study donor must be ≥ 110 pounds.
Study donor's body temperature must be ≤ 37.5°C / 99.5°F (oral).
Study donor's hemoglobin must be ≥12.5 g/dL if female and ≥13.0 g/dL if male.
Study donor's hematocrit must be ≥ 38% if female and ≥39% if male.Study participants must meet EITHER hemoglobin or hematocrit criteria.

Key exclusion criteria (11 listed)

Study donor is < 18 years of age.
Study donor < 110 pounds.
Study donor's body temperature is > 37.5°C / 99.5°F (oral).
Study donor's hemoglobin is < 12.5 g/dL if female and < 13.0 g/dL if male.
Study donor's hematocrit is < 38% if female and < 39% if male.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Hemanext Red Blood Cell Processing SystemLeukoreduced red blood cell product from donors in the Investigational Product arm will be processed in the Hemanext Oxygen Reduction Bag for 3 hours and then transferred to the Hemanext Storage Bag and stored for 42 days at 1-6°C.	Device	Investigational Product

Primary outcome

% of Red Blood Cells With Hemolysis
Time frame: On day 42 of storage
Percentage of packed Red Blood Cell units with hemolysis at day 42 of storage.
Dual Label 24 Hour In Vivo % Recovery of Red Blood Cells
Time frame: Day 42 of storage
The mean 24-hour, post-transfusion, in vivo red blood cell recovery.
% Red Blood Cells Recovered Post-Filtration
Time frame: Post-Filtration on Day 0
Percentage of red blood cells recovered after the filtration process.

Results and safety

Results posted to the registry on 17 Mar 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Investigational Product First, Then Control Product	48	40
Control Product First, Then Investigational Product	52	45

Primary outcome: % of Red Blood Cells With Hemolysis

Time frame: On day 42 of storage. Mean (Standard Deviation). Unit: % of Red Blood Cells with Hemolysis

Measure	Investigational Product n = 95	Control Product n = 94
Value	0.29 (0.168)	0.29 (0.152)

Primary outcome: Dual Label 24 Hour In Vivo % Recovery of Red Blood Cells

Time frame: Day 42 of storage. Mean (Standard Deviation). Unit: % Recovery of Red Blood Cells

Measure	Investigational Product n = 19	Control Product n = 21
Value	89.3 (5.81)	85.8 (6.12)

Primary outcome: % Red Blood Cells Recovered Post-Filtration

Time frame: Post-Filtration on Day 0. Mean (Standard Deviation). Unit: % of Red Blood Cells Recovered

Measure	Investigational Product n = 98	Control Product n = 96
Value	92.3 (1.9)	91.1 (4.31)

Adverse events

Time frame: Study-related adverse events are defined as those study participant-reported adverse events occurring within 24-hours of donation and/or transfusion. Non-study-related adverse events outside of these periods were not recorded unless they were of a nature to impact study participant evaluability, safety or data validity.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Investigational Product	1 of 100 (1%)	9 of 100 (9%)	0 of 100
Control Product	1 of 100 (1%)	9 of 100 (9%)	0 of 100

Limitations and caveats (from the sponsor): Disclaimer: The 51-Cr/99-Tc(m) labeling for 14 study subjects occurred without prior RDRC approval and was done at a site that did not meet GMP standards.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Faye West, MD principal investigator

American Red Cross Mid-Atlantic Research Facility

Jose A Cancelas Perez, MD, PhD principal investigator

Hoxworth Blood Center

Matthew Karafin, MD principal investigator

Versiti Blood Health

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Hemanext Red Blood Cell Processing System in people with Whole Blood Donation and Leukoreduction, run by Hemanext at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

% of Red Blood Cells With Hemolysis (time frame: On day 42 of storage). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03301779.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2020.