Whole Blood Donations and LeukoreductionPhase 2NCT04418934
Clinical Investigation to Evaluate the Hemanext® Red Blood Cell Processing System for Extended Storage of Leukoreduced Red Blood Cells
A Phase 2 study testing Hemanext One in people with Whole Blood Donations and Leukoreduction, run by Hemanext at 2 sites in United States.
Trial summary
The primary goal of Hemanext Inc. is to improve the safety and efficacy of transfusion therapy through novel storage methods potentially improving their quality across the storage cycle. 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 Donations and Leukoreduction
- What is being tested?
- Hemanext One
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Jul 2020to 1 May 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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).
- 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.
- Study donor's testing results from collected blood does not indicate a risk of transfusion-transmitted disease (TTD).
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- 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).
- 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
2 sites in 1 country.
United States2 sites
Hoxworth Blood Center, University of Cincinnati
Cincinnati, Ohio, 45267-0055
American Red Cross Mid-Atlantic Research Facility
Norfolk, Virginia, 23510
About this study
Official title: Clinical Investigation to Evaluate the Hemanext® Red Blood Cell Processing System for Extended Storage of Leukoreduced Red Blood Cells With CP2D Anticoagulant and AS-3 Additive - Pivotal Trial
The primary goal of Hemanext Inc. is to improve the safety and efficacy of transfusion therapy through novel storage methods potentially improving their quality across the storage cycle. 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 (RBC) over the course of storage leading to decreased therapeutic potential. Therefore, removal of oxygen from red blood cell products prior to storage has potential to preserve the cells in a more physiologically relevant state and improve the clinical outcomes of patients that receive blood transfusions in a variety of therapeutic realms1.
Currently, Hemanext Inc. has focused on the design and development of a dual compartment bag system designated as the Hemanext Red Blood Cell Processing System (Hemanext). After standard processing of donated whole blood units into leukoreduced packed red blood cells (LR-RBCs) in AS-3 additive solution, the LR-RBCs would then be placed in the oxygen reduction bag (ORB) processing bag 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 hypoxic state of the LR-RBC product for the duration of cold storage.
The COVID-19 crisis has placed unprecedented pressure on the US blood supply security. The pandemic has caused blood supplies to fall precipitously, placing all transfusion recipients at acute risk. Hemanext has developed a technology over 12 years with support from 6 NIH grants and contracts that can substantially mitigate the damage done to the blood supply by this COVID-19 crisis and strengthen the ability of the US blood supply to withstand the effects of future crises. Limited shelf life is a key component in exacerbating the current blood supply crisis. Successful completion of this project will allow earliest possible availability (within 9-12 months) of the high quality Hemanext RBC with significantly extended shelf life. Even without shelf life extension, the higher quality Hemanext RBC showed a reduction of >50% of blood volume required for resuscitation from hemorrhage in a pre-clinical rodent model. Further enhancement of the quality of Hemanext RBC is expected to improve still further the efficacy of Hemanext blood and further to reduce the transfusion volume needed to achieve treatment objectives. In addition, extending the shelf life of the Hemanext RBC will provide greater inventory flexibility to avoid the devastating impact of major blood shortages due to reduced donor activity during threats to blood security such a COVID-19 pandemics and other crises.
- Conditions
- Whole Blood Donations and Leukoreduction
- Being tested
- Hemanext One
- Keywords
- Red Blood Cells
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hemanext OneDevice
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 56 days at 1-6°C.
| Study group | Role | What they receive |
|---|---|---|
| Investigational Product | Experimental | Blood product from these donors will be processed and stored using the Hemanext One device. Receives: Device: Hemanext One |
| 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 56 of storage.
Measured: Day 56 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 56 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.
- First posted5 Jun 2020
- Study start1 Jul 2020 (estimated)
- Primary completion1 May 2021 (estimated)
- Study completion1 May 2021 (estimated)
Why it stopped: Grant application for study was rejected
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Whole Blood Donations 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hemanext
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jose Cancelas, MD, PhD, Principal investigator, Hoxworth Blood CenterPhilip Howard, MD, Principal investigator, American Red Cross Mid-Atlantic Research Facility
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04418934
- Sponsor's protocol ID
- CLIN-0004
- Status last verified
- Jul 2020
- First submitted
- 26 May 2020
- Last updated
- 3 Aug 2020
- Results posted
- No
- 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 3 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Investigation to Evaluate the Hemanext® Red Blood Cell Processing System for Extended Storage of Leukoreduced Red Blood Cells With CP2D Anticoagulant and AS-3 Additive - Pivotal Trial
- ClinicalTrials.gov ID
- NCT04418934
- Acronym / sponsor ID
- CLIN-0004
- Conditions
- Whole Blood Donations and Leukoreduction
- Keywords
- Red Blood Cells
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Grant application for study was rejected
- Enrolment
- 0 participants (actual)
- Lead sponsor
- HemanextIndustry (pharma, biotech, devices)
- Study start
- 1 Jul 2020 (estimated)
- Primary completion
- 1 May 2021 (estimated)
- Study completion
- 1 May 2021 (estimated)
- First posted
- 5 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary goal of Hemanext Inc. is to improve the safety and efficacy of transfusion therapy through novel storage methods potentially improving their quality across the storage cycle. 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 (RBC) over the course of storage leading to decreased therapeutic potential. Therefore, removal of oxygen from red blood cell products prior to storage has potential to preserve the cells in a more physiologically relevant state and improve the clinical outcomes of patients that receive blood transfusions in a variety of therapeutic realms1.
Currently, Hemanext Inc. has focused on the design and development of a dual compartment bag system designated as the Hemanext Red Blood Cell Processing System (Hemanext). After standard processing of donated whole blood units into leukoreduced packed red blood cells (LR-RBCs) in AS-3 additive solution, the LR-RBCs would then be placed in the oxygen reduction bag (ORB) processing bag 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 hypoxic state of the LR-RBC product for the duration of cold storage.
The COVID-19 crisis has placed unprecedented pressure on the US blood supply security. The pandemic has caused blood supplies to fall precipitously, placing all transfusion recipients at acute risk. Hemanext has developed a technology over 12 years with support from 6 NIH grants and contracts that can substantially mitigate the damage done to the blood supply by this COVID-19 crisis and strengthen the ability of the US blood supply to withstand the effects of future crises. Limited shelf life is a key component in exacerbating the current blood supply crisis. Successful completion of this project will allow earliest possible availability (within 9-12 months) of the high quality Hemanext RBC with significantly extended shelf life. Even without shelf life extension, the higher quality Hemanext RBC showed a reduction of >50% of blood volume required for resuscitation from hemorrhage in a pre-clinical rodent model. Further enhancement of the quality of Hemanext RBC is expected to improve still further the efficacy of Hemanext blood and further to reduce the transfusion volume needed to achieve treatment objectives. In addition, extending the shelf life of the Hemanext RBC will provide greater inventory flexibility to avoid the devastating impact of major blood shortages due to reduced donor activity during threats to blood security such a COVID-19 pandemics and other crises.
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 OneBlood product from these donors will be processed and stored using the Hemanext One device. |
| 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 (10 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.
- Study donor must meet all criteria per respective site's Research Blood Donation Record (BDR).
- 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.
Key exclusion criteria (5 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. Study donor does not meet all criteria per respective site's Research Blood Donation Record (BDR).
- 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.
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 OneLeukoreduced 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 56 days at 1-6°C. | Device | Investigational Product |
Primary outcome
% of Red Blood Cells With Hemolysis
Time frame: Day 56 of storage
Percentage of packed Red Blood Cell units with hemolysis at day 56 of storage.
Dual Label 24 Hour In Vivo % Recovery of Red Blood Cells
Time frame: Day 56 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
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2020.
- 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.
Jose Cancelas, MD, PhD principal investigator
Hoxworth Blood Center
Philip Howard, MD principal investigator
American Red Cross Mid-Atlantic Research Facility
2 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 One in people with Whole Blood Donations and Leukoreduction, run by Hemanext at 2 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 10 inclusion and 5 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: withdrawn, as of the sponsor's last update on 3 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
The study was withdrawn before enrolling participants, so there are no results.
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: Day 56 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?
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 3 Aug 2020.