Blood DonorsPhase 1NCT02145507
Evaluation of Whole Blood With CPD Anticoagulant and AS-7/SOLX Additive Solution
A Phase 1 study testing SOLX (Investigational) in people with Blood Donors, run by Haemonetics Corporation at 2 sites in United States.
Trial summary
This study will evaluate a new blood collection and filtration system that is intended to be used to collect, filter, separate and store red blood cells and, separately, plasma. The new blood collection and filtration system will be compared to an already-approved and currently used system. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Blood Donors
- What is being tested?
- SOLX (Investigational)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2014to Jan 2015
- Phase
- Phase 1
- 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
- Age - Study donor must be ≥ 18 years of age
- Weight - Study donor must be ≥ 110 pounds
- Temperature - Study donor's body temperature must be ≤ 37.5°C / 99.5°F (oral)
- Hemoglobin - Study donor's hemoglobin must be ≥12.5 g/dL
- Hematocrit - Study donor's hematocrit must be ≥ 38%. Donor Eligibility - Study donor must meet all criteria per respective site's Research Blood Donation Record (BDR)
- Prior Donation - 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
Show all 10Show fewer
- Informed Consent - 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
- Blood-borne Pathogens - Study donor's testing results from collected blood does not indicate a risk of transfusion-transmitted disease (TTD)
- Adverse Events - 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
- Pregnancy - Female study donors must not be pregnant, expected to be pregnant or breastfeeding. Only 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
- -Failure to meet one or more of the above criteria
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Hoxworth Blood Center
Cincinnati, Ohio, 45267
American Red Cross Mid-Atlantic Region Blood Services
Norfolk, Virginia, 23507
About this study
Official title: Clinical Investigation to Evaluate the Haemonetics LeukoSep Leukocyte Reduction Filtration System for Whole Blood With CPD Anticoagulant and SOLX Additive - Pivotal Trial
This study will evaluate a new blood collection and filtration system that is intended to be used to collect, filter, separate and store red blood cells and, separately, plasma. The new blood collection and filtration system will be compared to an already-approved and currently used system. Further, this study will evaluate new processing conditions relative to the individual components of the collection and filtration system. All study participants will donate two units of whole blood with individual units being donated at least 56 days apart. One unit of whole blood will be donated with the new system, and the other unit will be collected with the already-approved system. A subset of the donors (approximately 24 of the 120 participants) will have a small quantity of their red blood cells injected back into their body 42-days after they were donated in order to evaluate how well the red blood cells survive. Blood and blood products from all donors will be analyzed the day of collection and after storage (plasma after at least 30 days of storage and red blood cells after exactly 42 days of storage).
Read the detailed description
In vitro and in vivo performance of SOLX® RBCs produced with the modified SOLX® System will be used to demonstrate the acceptability of both the proposed product modification and expanded indications. To accomplish this, the study will require a total of 120 evaluable donors completing the study. Enrolled donors will be assigned to either of two study arms. Each study arm will entail a randomized, paired, 2-x-2 crossover design where every study donor (n = 60 evaluable study donors who complete the study per arm) 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 collected with the investigational product (IP) and the other unit will be collected with the control product (CP). 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.
Each of the two study arms will evaluate outcomes resulting from different storage, filtration and processing conditions:
- Arm 1 will entail holding whole blood units at 20-24°C after collection for ≥ 20 hours (IP) or ≥ 6 hours (CP) prior to initiating room temperature filtration. Following room temperature centrifugation and subsequent separation, SOLX® PRBC will be placed at 1-6°C and plasma placed at ≤ -18°C within 24 hours (IP) or within 8 hour (CP) of collection. The first donation will occur with product indicated per randomization and the second donation will occur with product alternate to the randomization. Arm 1 will further entail an in vivo double-radiolabelled autologous RBC recovery substudy (n = 20-24, paired IP and CP data will be collected) and an evaluation of pre- and post-rejuvenation PRBC 2,3-DPG levels (all IP and CP units). The in vivo substudy and rejuvenation evaluation is limited to only Arm 1 and is not included in Arm 2.
- Arm 2 will entail holding whole blood units at 1-6°C after collection for ≥ 66 hours (both IP and CP) prior to initiating cold filtration. Following refrigerated centrifugation and subsequent separation, SOLX® PRBCs will be placed at 1-6°C within 72 hours of collection (both IP and CP). Plasma will not be evaluated for this arm and will be discarded. The first donation will occur with product indicated per randomization and the second donation will occur with product alternate to the randomization.
For each study arm that does not meet the protocol-defined in vitro acceptance criteria for exactly 1 unit, an additional 71 evaluable donors will be enrolled, thus increasing the number of evaluable enrolled donors completing the respective study arm to 131 donors. Only those acceptance criteria endpoints that were not met within their respective study arm will be evaluated and neither matched/paired crossover controls nor in vivo RBC recovery (Arm 1 In vivo substudy) will be evaluated. If all protocol defined in vitro acceptance criteria are met or > 1 subject does not meet the protocol defined in vitro acceptance criteria relative to a specific study arm, then no enrollment will occur relative to the same study arm.
- Conditions
- Blood Donors
- Being tested
- SOLX (Investigational), AS-3 (Control)
- Keywords
- Leukoreduction, Red Blood Cell post-leukoreduction recovery, Packed red blood cell post storage hemolysis, Red blood cell recovery, Plasma clotting factors, 2,3-DPG rejuvenation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SOLX (Investigational)Drug
Also called AS-7, Additive solution 7
SOLX is regulated as a drug but is not intended to provide a direct therapeutic benefit.
AS-3 (Control)Drug
Also called Additive solution formula 3
AS-3 solution is regulated as a drug but is not intended to provide a direct therapeutic benefit
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Room Temperature Storage/Filtration | Other | SOLX (Investigational Product) and AS-3 (Control) Receives: Drug: SOLX (Investigational); Drug: AS-3 (Control) |
| Arm 2 : Cold storage | Other | SOLX (Investigational Product) and AS-3 (Control) Receives: Drug: SOLX (Investigational); Drug: AS-3 (Control) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Red Blood Cell Post-filtration Recovery
The percent of recovered red blood cells when the content of pre-filtration whole blood is compared to the post-filtration leukoreduced whole blood content.
Measured: Arm and product dependent (< 8 hours, 20-24 hours, 66-72 hours post collection)
Residual Leukocyte Count
The level of residual white blood cells in whole blood filtered after either <8 hours (AS-3) or 20-24hours (SOLX) of room temperature storage or cold storage for 72 hours.
Measured: <8 hours and 20-24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2014 (estimated)
- Study startApr 2014
- Primary completionDec 2014
- Study completionJan 2015
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 Blood DonorsStudies 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 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haemonetics Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lou A Maes, MD, Principal investigator, ARC Mid-Atlantic Region Blood ServicesJose Cancelas, MD, Principal investigator, Hoxworth Blood Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02145507
- Sponsor's protocol ID
- TP-CLN-100331
- Status last verified
- Mar 2022
- First submitted
- 19 May 2014
- Last updated
- 25 Apr 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Investigation to Evaluate the Haemonetics LeukoSep Leukocyte Reduction Filtration System for Whole Blood With CPD Anticoagulant and SOLX Additive - Pivotal Trial
- ClinicalTrials.gov ID
- NCT02145507
- Acronym / sponsor ID
- TP-CLN-100331
- Conditions
- Blood Donors
- Keywords
- Leukoreduction, Red Blood Cell post-leukoreduction recovery, Packed red blood cell post storage hemolysis, Red blood cell recovery, Plasma clotting factors, 2,3-DPG rejuvenation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- Haemonetics CorporationIndustry (pharma, biotech, devices)
- Study start
- Apr 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 23 May 2014 (estimated)
- Results
- Posted 28 Mar 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate a new blood collection and filtration system that is intended to be used to collect, filter, separate and store red blood cells and, separately, plasma. The new blood collection and filtration system will be compared to an already-approved and currently used system. Further, this study will evaluate new processing conditions relative to the individual components of the collection and filtration system. All study participants will donate two units of whole blood with individual units being donated at least 56 days apart. One unit of whole blood will be donated with the new system, and the other unit will be collected with the already-approved system. A subset of the donors (approximately 24 of the 120 participants) will have a small quantity of their red blood cells injected back into their body 42-days after they were donated in order to evaluate how well the red blood cells survive. Blood and blood products from all donors will be analyzed the day of collection and after storage (plasma after at least 30 days of storage and red blood cells after exactly 42 days of storage).
Detailed description
In vitro and in vivo performance of SOLX® RBCs produced with the modified SOLX® System will be used to demonstrate the acceptability of both the proposed product modification and expanded indications. To accomplish this, the study will require a total of 120 evaluable donors completing the study. Enrolled donors will be assigned to either of two study arms. Each study arm will entail a randomized, paired, 2-x-2 crossover design where every study donor (n = 60 evaluable study donors who complete the study per arm) 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 collected with the investigational product (IP) and the other unit will be collected with the control product (CP). 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.
Each of the two study arms will evaluate outcomes resulting from different storage, filtration and processing conditions:
- Arm 1 will entail holding whole blood units at 20-24°C after collection for ≥ 20 hours (IP) or ≥ 6 hours (CP) prior to initiating room temperature filtration. Following room temperature centrifugation and subsequent separation, SOLX® PRBC will be placed at 1-6°C and plasma placed at ≤ -18°C within 24 hours (IP) or within 8 hour (CP) of collection. The first donation will occur with product indicated per randomization and the second donation will occur with product alternate to the randomization. Arm 1 will further entail an in vivo double-radiolabelled autologous RBC recovery substudy (n = 20-24, paired IP and CP data will be collected) and an evaluation of pre- and post-rejuvenation PRBC 2,3-DPG levels (all IP and CP units). The in vivo substudy and rejuvenation evaluation is limited to only Arm 1 and is not included in Arm 2.
- Arm 2 will entail holding whole blood units at 1-6°C after collection for ≥ 66 hours (both IP and CP) prior to initiating cold filtration. Following refrigerated centrifugation and subsequent separation, SOLX® PRBCs will be placed at 1-6°C within 72 hours of collection (both IP and CP). Plasma will not be evaluated for this arm and will be discarded. The first donation will occur with product indicated per randomization and the second donation will occur with product alternate to the randomization.
For each study arm that does not meet the protocol-defined in vitro acceptance criteria for exactly 1 unit, an additional 71 evaluable donors will be enrolled, thus increasing the number of evaluable enrolled donors completing the respective study arm to 131 donors. Only those acceptance criteria endpoints that were not met within their respective study arm will be evaluated and neither matched/paired crossover controls nor in vivo RBC recovery (Arm 1 In vivo substudy) will be evaluated. If all protocol defined in vitro acceptance criteria are met or > 1 subject does not meet the protocol defined in vitro acceptance criteria relative to a specific study arm, then no enrollment will occur relative to the same study arm.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Room Temperature Storage/Filtration | Other | Drug: SOLX (Investigational), Drug: AS-3 (Control)SOLX (Investigational Product) and AS-3 (Control) |
| Arm 2 : Cold storage | Other | Drug: SOLX (Investigational), Drug: AS-3 (Control)SOLX (Investigational Product) and AS-3 (Control) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age - Study donor must be ≥ 18 years of age
- Weight - Study donor must be ≥ 110 pounds
- Temperature - Study donor's body temperature must be ≤ 37.5°C / 99.5°F (oral)
- Hemoglobin - Study donor's hemoglobin must be ≥12.5 g/dL
- Hematocrit - Study donor's hematocrit must be ≥ 38%. Donor Eligibility - Study donor must meet all criteria per respective site's Research Blood Donation Record (BDR)
Key exclusion criteria (1 listed)
- -Failure to meet one or more of the above criteria
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 |
|---|---|---|
| SOLX (Investigational)Also: AS-7, Additive solution 7SOLX is regulated as a drug but is not intended to provide a direct therapeutic benefit. | Drug | Arm 1: Room Temperature Storage/Filtration, Arm 2 : Cold storage |
| AS-3 (Control)Also: Additive solution formula 3AS-3 solution is regulated as a drug but is not intended to provide a direct therapeutic benefit | Drug | Arm 1: Room Temperature Storage/Filtration, Arm 2 : Cold storage |
Primary outcome
Red Blood Cell Post-filtration Recovery
Time frame: Arm and product dependent (< 8 hours, 20-24 hours, 66-72 hours post collection)
The percent of recovered red blood cells when the content of pre-filtration whole blood is compared to the post-filtration leukoreduced whole blood content.
Residual Leukocyte Count
Time frame: <8 hours and 20-24 hours
The level of residual white blood cells in whole blood filtered after either <8 hours (AS-3) or 20-24hours (SOLX) of room temperature storage or cold storage for 72 hours.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Blood Donors
Not yet recruitingObservational study
Collection and Distribution of Blood Components From Healthy Donors for In Vitro Research Use
Blood Donors, Apheresis
Enrolling by invitationObservational study
Screening for Hematology Branch Protocols
Hematologic Disease and Disorders, Donors
RecruitingObservational study
COLLECT BLOOD/RESEARCH USE
Blood Donors, Research Subjects
Active, not recruitingObservational study
Blood Biomarkers in Pediatric Kidney Transplant Recipients
Rejection of Kidney Allograft
RecruitingObservational study
Trifecta-Lung cfDNA-MMDx Study
Lung Transplantation
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.
Lou A Maes, MD principal investigator
ARC Mid-Atlantic Region Blood Services
Jose Cancelas, MD principal investigator
Hoxworth Blood Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SOLX (Investigational) in people with Blood Donors, run by Haemonetics Corporation 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 1 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 25 Apr 2022. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 28 Mar 2022). 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?
Red Blood Cell Post-filtration Recovery (time frame: Arm and product dependent (< 8 hours, 20-24 hours, 66-72 hours post collection)). The study lists 2 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 25 Apr 2022.