Healthy VolunteersNCT03097289
In Vivo Recovery and Survival Study of Platelets Collected on Trima Accel System and Stored in InterSol Solution
A study testing Trima Accel system in people with Healthy Volunteers, run by Terumo BCT at 2 sites in United States.
Trial summary
The purpose of this study is to evaluate the quality of platelets collected on the Trima Accel system after storage for 5 days in a Platelet Additive Solution (PAS), called InterSol. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Trima Accel system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 2 sitesUnited States
- Study dates
- 26 Jul 2017to 24 Nov 2017
- Phase
- Interventional
- 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 18 years or older
- Normal health status as per AABB criteria for a healthy donor
- Able to commit to the study schedule
- Meets the inclusion criteria defined by the Blood Center for an apheresis platelet with PAS collection on the Trima Accel system. These criteria are based on FDA Regulations and AABB standards. Note: Participants who are deferred from volunteer community donations because of travel restrictions, piercings, or tattoos may participate in the study, as products are not transfused
- Participants of child-bearing potential (either male or female) must agree to use an effective method of contraception during the course of the study
- Female of childbearing potential must be willing to take a pregnancy test prior to infusion of radiolabeled platelets
- Has given written informed consent
Who cannot join
- Previously received radiation therapy
- Has been diagnosed with a platelet disorder (ie, platelet dysfunction)
- Already participated in 4 research studies involving radioisotopes within the contemporaneous calendar-year
- Pregnant or nursing females
- Participation currently, or within the last 12 months, in another investigational trial that would potentially interfere with the analysis of this investigation
- History of known hypersensitivity to indium or chromium
- Treatment with aspirin or aspirin containing medications within 7 days of apheresis or treatment with non-steroidal anti inflammatory drugs (NSAID), anti-platelet agents or other drugs affecting platelet viability within 3 days of apheresis (eg, ibuprofen or other NSAIDs)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Hoxworth Blood Center
Cincinnati, Ohio, 45267
BloodCenter of Wisconsin
Milwaukee, Wisconsin, 53233
About this study
Official title: An In Vivo Recovery and Survival Study of Platelets Collected on the Trima Accel System and Stored in InterSol Solution
The purpose of this study is to evaluate the quality of platelets collected on the Trima Accel system after storage for 5 days in a Platelet Additive Solution (PAS), called InterSol.
Read the detailed description
Platelets suspended in platelet additive solutions (PAS) have been collected and transfused in Europe for over 20 years. These PAS solutions outside of the United States (US) are not tied to an apheresis device; however in the US, PAS solutions have traditionally been linked to a corresponding apheresis device.
Currently in the US, there are two solutions approved by the Food and Drug Administration (FDA) as a PAS for the replacement of 65% plasma in platelet components. Isoplate Solution is approved for use with the Trima Accel® Automated Blood Collection System (Trima Accel System) and InterSol Solution is approved for use with the Amicus Separator System.
Terumo BCT is pursuing FDA clearance for InterSol in combination with the Trima Accel system in order to provide blood centers with the option to use InterSol as well as Isoplate Solution when collecting platelets to be stored in a PAS.
This is a prospective, open-label, multicenter, controlled study. Up to 40 healthy adult subjects will be enrolled in this study to ensure 24 evaluable subjects across two Investigational Sites. Evaluable is defined as the subject completing the recovery and survival procedure and neither the subject or the product meeting any of the Clinical Investigation Plan (CIP) analysis exclusion criteria.
The additional platelet donors account for screen failures, incomplete procedures and CIP exclusions.
Two (2) sets of platelets will be collected from each subject:
- A Test unit - A hyperconcentrated platelet product collected on the Trima Accel system and diluted to a final ratio of 65% InterSol/35% plasma through the addition of InterSol directly to the platelet bag by the Trima Accel system after collection.
- A Control sample - Fresh platelets prepared from a whole blood sample drawn from the same subject on Study Day 5 in accordance with standard procedure.
Eligible donors who have signed an informed consent will be enrolled.
SUBJECT PROCEDURES
Screening can be performed within 5 days of the apheresis procedure or combined with the Apheresis visit.
The following evaluations will be performed:
- Informed consent will be obtained prior to initiating any study specific procedures
- Eligibility will be confirmed
- Demographics (age, gender, race, ethnic origin), height, and weight
- Record medical history as per AABB criteria for healthy donors
Apheresis Visit
The following procedures will be performed:
- Eligibility will be confirmed
- Finger stick hemoglobin
- Apheresis procedure
Apheresis procedures will be run according to the instructions and precautions described in the commercially available Trima Accel Operator's Manual.
The Investigator or designee will perform the venipuncture, monitor the subject during the collection, assess and provide any interventions for adverse effects, remove the needle, dress the puncture site and monitor subject through recovery.
The following information will be documented:
- Trima procedure details
- Adverse events (AEs)
- Medications to treat adverse events
- Device deficiencies
Infusion Day Visit
Five (5) days after a study subject has completed the apheresis procedure to collect Test platelets, they will return for the donation of fresh Control platelets, reinfusion of radiolabeled Test and Control platelets, and post-infusion sampling.
The following procedures will be conducted:
- Confirm eligibility
- Conduct pregnancy test for women of childbearing potential (serum or urine)
- Review adverse events since the previous visit
- Collect a whole blood sample for the production of Control platelets
- Radiolabel Test and Control platelets and prepare for infusion
- Infuse radiolabeled combined Test and Control platelets into subject's vein
- Collect a 5-10 mL blood sample for pre- and post-infusion testing using the opposite arm as for the infusion
The following will be documented:
- Vital signs (blood pressure, heart rate, temperature)
- Adverse events
- Medications to treat adverse events
The subject will return to the study site daily (except on weekends) between Study Day 6 and Study Day 12 . A total of 5 blood samples are required to be collected in this 7 day period in order for the subject's data to be evaluable. The subject will also return to the study site for a final visit on Study Day 16.
At each of these visits a blood sample will be collected for testing.
The following will be documented:
- Adverse events
- Medications to treat adverse events
- Conditions
- Healthy Volunteers
- Being tested
- Trima Accel system
- Keywords
- Healthy Adults
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trima Accel systemDevice
A platelet apheresis procedure involves connecting the blood in the donor's vein through tubing to a machine that separates the blood components. After the separation, the desired component of the blood is removed (platelets and plasma), while the remainder of the blood components are reinfused back into the patient. To prevent clotting, an anticoagulant (ACDA) is used throughout the procedure. Following each blood collection, Platelet Additive Solution (PAS), InterSol, will be added to the platelet product to prepare the final product for 5 day storage. The entire procedure is painless and should take 90 to 120 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Platelets stored in InterSol | Experimental | Platelets collected on the Trima Accel system and stored in 65% InterSol/35% plasma Receives: Device: Trima Accel system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recovered Percentage of the Extrapolated Platelet Count at Time 0
The percent recovery of platelets stored in InterSol for 5 Days as compared to fresh controls. Percent recovery was expressed as a percentage and was extrapolated for a value at Time 0. The FDA acceptance criteria for recovery is >66% of control with a 1-sided 97.5% confidence limit.
Measured: 11 days (+/- 1 day)
Number of Days of Platelet Survival
Survival of platelets stored in InterSol for 5 Days as compared to fresh controls. Survival was expressed in days and was approximated using linear regression. The FDA acceptance criteria for survival is >58% of control with a 1-sided 97.5% confidence limit
Measured: 11 days (+/- 1 day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2017
- Study start26 Jul 2017
- Primary completion24 Nov 2017
- Study completion24 Nov 2017
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 Healthy VolunteersStudies 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 N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Apheresis platelets will be collected on the Trima Accel system and stored in 65% InterSol/35% plasma for all subjects
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Terumo BCT
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jose Cancelas, MD, PhD, Principal investigator, Hoxworth Blood CenterMehraboon S Irani, MD, Principal investigator, Versiti Blood Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03097289
- Sponsor's protocol ID
- CTS-5066
- Status last verified
- Nov 2018
- First submitted
- 17 Mar 2017
- Last updated
- 19 Dec 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An In Vivo Recovery and Survival Study of Platelets Collected on the Trima Accel System and Stored in InterSol Solution
- ClinicalTrials.gov ID
- NCT03097289
- Acronym / sponsor ID
- CTS-5066
- Conditions
- Healthy Volunteers
- Keywords
- Healthy Adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Terumo BCTIndustry (pharma, biotech, devices)
- Study start
- 26 Jul 2017 (actual)
- Primary completion
- 24 Nov 2017 (actual)
- Study completion
- 24 Nov 2017 (actual)
- First posted
- 31 Mar 2017 (actual)
- Results
- Posted 27 Nov 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the quality of platelets collected on the Trima Accel system after storage for 5 days in a Platelet Additive Solution (PAS), called InterSol.
Detailed description
Platelets suspended in platelet additive solutions (PAS) have been collected and transfused in Europe for over 20 years. These PAS solutions outside of the United States (US) are not tied to an apheresis device; however in the US, PAS solutions have traditionally been linked to a corresponding apheresis device.
Currently in the US, there are two solutions approved by the Food and Drug Administration (FDA) as a PAS for the replacement of 65% plasma in platelet components. Isoplate Solution is approved for use with the Trima Accel® Automated Blood Collection System (Trima Accel System) and InterSol Solution is approved for use with the Amicus Separator System.
Terumo BCT is pursuing FDA clearance for InterSol in combination with the Trima Accel system in order to provide blood centers with the option to use InterSol as well as Isoplate Solution when collecting platelets to be stored in a PAS.
This is a prospective, open-label, multicenter, controlled study. Up to 40 healthy adult subjects will be enrolled in this study to ensure 24 evaluable subjects across two Investigational Sites. Evaluable is defined as the subject completing the recovery and survival procedure and neither the subject or the product meeting any of the Clinical Investigation Plan (CIP) analysis exclusion criteria.
The additional platelet donors account for screen failures, incomplete procedures and CIP exclusions.
Two (2) sets of platelets will be collected from each subject:
- A Test unit - A hyperconcentrated platelet product collected on the Trima Accel system and diluted to a final ratio of 65% InterSol/35% plasma through the addition of InterSol directly to the platelet bag by the Trima Accel system after collection.
- A Control sample - Fresh platelets prepared from a whole blood sample drawn from the same subject on Study Day 5 in accordance with standard procedure.
Eligible donors who have signed an informed consent will be enrolled.
SUBJECT PROCEDURES
Screening can be performed within 5 days of the apheresis procedure or combined with the Apheresis visit.
The following evaluations will be performed:
- Informed consent will be obtained prior to initiating any study specific procedures
- Eligibility will be confirmed
- Demographics (age, gender, race, ethnic origin), height, and weight
- Record medical history as per AABB criteria for healthy donors
Apheresis Visit
The following procedures will be performed:
- Eligibility will be confirmed
- Finger stick hemoglobin
- Apheresis procedure
Apheresis procedures will be run according to the instructions and precautions described in the commercially available Trima Accel Operator's Manual.
The Investigator or designee will perform the venipuncture, monitor the subject during the collection, assess and provide any interventions for adverse effects, remove the needle, dress the puncture site and monitor subject through recovery.
The following information will be documented:
- Trima procedure details
- Adverse events (AEs)
- Medications to treat adverse events
- Device deficiencies
Infusion Day Visit
Five (5) days after a study subject has completed the apheresis procedure to collect Test platelets, they will return for the donation of fresh Control platelets, reinfusion of radiolabeled Test and Control platelets, and post-infusion sampling.
The following procedures will be conducted:
- Confirm eligibility
- Conduct pregnancy test for women of childbearing potential (serum or urine)
- Review adverse events since the previous visit
- Collect a whole blood sample for the production of Control platelets
- Radiolabel Test and Control platelets and prepare for infusion
- Infuse radiolabeled combined Test and Control platelets into subject's vein
- Collect a 5-10 mL blood sample for pre- and post-infusion testing using the opposite arm as for the infusion
The following will be documented:
- Vital signs (blood pressure, heart rate, temperature)
- Adverse events
- Medications to treat adverse events
The subject will return to the study site daily (except on weekends) between Study Day 6 and Study Day 12 . A total of 5 blood samples are required to be collected in this 7 day period in order for the subject's data to be evaluable. The subject will also return to the study site for a final visit on Study Day 16.
At each of these visits a blood sample will be collected for testing.
The following will be documented:
- Adverse events
- Medications to treat adverse events
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Apheresis platelets will be collected on the Trima Accel system and stored in 65% InterSol/35% plasma for all subjects
| Arm | Type | Receives |
|---|---|---|
| Platelets stored in InterSol | Experimental | Device: Trima Accel systemPlatelets collected on the Trima Accel system and stored in 65% InterSol/35% plasma |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18 years or older
- Normal health status as per AABB criteria for a healthy donor
- Able to commit to the study schedule
- Meets the inclusion criteria defined by the Blood Center for an apheresis platelet with PAS collection on the Trima Accel system. These criteria are based on FDA Regulations and AABB standards. Note: Participants who are deferred from volunteer community donations because of travel restrictions, piercings, or tattoos may participate in the study, as products are not transfused
- Participants of child-bearing potential (either male or female) must agree to use an effective method of contraception during the course of the study
Key exclusion criteria (7 listed)
- Previously received radiation therapy
- Has been diagnosed with a platelet disorder (ie, platelet dysfunction)
- Already participated in 4 research studies involving radioisotopes within the contemporaneous calendar-year
- Pregnant or nursing females
- Participation currently, or within the last 12 months, in another investigational trial that would potentially interfere with the analysis of this investigation
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 |
|---|---|---|
| Trima Accel systemA platelet apheresis procedure involves connecting the blood in the donor's vein through tubing to a machine that separates the blood components. After the separation, the desired component of the blood is removed (platelets and plasma), while the remainder of the blood components are reinfused back into the patient. To prevent clotting, an anticoagulant (ACDA) is used throughout the procedure. Following each blood collection, Platelet Additive Solution (PAS), InterSol, will be added to the platelet product to prepare the final product for 5 day storage. The entire procedure is painless and should take 90 to 120 minutes. | Device | Platelets stored in InterSol |
Primary outcome
Recovered Percentage of the Extrapolated Platelet Count at Time 0
Time frame: 11 days (+/- 1 day)
The percent recovery of platelets stored in InterSol for 5 Days as compared to fresh controls. Percent recovery was expressed as a percentage and was extrapolated for a value at Time 0. The FDA acceptance criteria for recovery is >66% of control with a 1-sided 97.5% confidence limit.
Number of Days of Platelet Survival
Time frame: 11 days (+/- 1 day)
Survival of platelets stored in InterSol for 5 Days as compared to fresh controls. Survival was expressed in days and was approximated using linear regression. The FDA acceptance criteria for survival is >58% of control with a 1-sided 97.5% confidence limit
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Screening Protocol
Pain
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
Mehraboon S Irani, MD principal investigator
Versiti Blood Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trima Accel system in people with Healthy Volunteers, run by Terumo BCT 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 7 inclusion and 7 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 19 Dec 2018. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Nov 2018). 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?
Recovered Percentage of the Extrapolated Platelet Count at Time 0 (time frame: 11 days (+/- 1 day)). 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 19 Dec 2018.