Healthy VolunteersNCT02684630

Trima Accel® System Post Count Algorithm Study

A study testing Trima Accel System in people with Healthy Volunteers, run by Terumo BCT at 2 sites in United States.

Completed

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

Trial summary

The purpose of this study is to optimize collected platelet yields in single and double platelet collections, while maintaining donor postplatelet count of >100,000/µL. 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: 131 participants
Where: 2 sitesUnited States
Study dates: 28 Jan 2016to 28 May 2016
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.
Meets Blood Center criteria for blood donation and is scheduled for an apheresis procedure that includes a single or double platelet product. These criteria are based on FDA Regulations and American Association of Blood Banks (AABB) Guidelines.
Appears to have adequate venous access to obtain a postprocedure platelet count.
Has given written informed consent.

Who cannot join

Has undergone a splenectomy.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Bonfils Blood Center
Denver, Colorado, 80230
San Diego Blood Bank
San Diego, California, 92102

Other trials in United States

About this study

Official title: A Multicenter Study to Evaluate Modified Postcount Algorithm Software on the Trima Accel® System in Volunteer Blood Donors

The purpose of this study is to optimize collected platelet yields in single and double platelet collections, while maintaining donor postplatelet count of >100,000/µL.

Read the detailed description

This is a prospective, open-label, non-randomized study to evaluate Trima Accel System modified postcount algorithm software.

Platelets will be collected according to the Trima Accel System Operator's Manual. Collection procedures will include those in which:

a single platelet product is collected
a double platelet product is collected, with or without other components.

Study participation will be up to 8 days. The apheresis procedure can last from 25 to 150 minutes, dependent upon the product(s) to be collected, machine configuration, donor parameters, the quality of the vascular access, and the tolerance of the donor to the citrate anticoagulant.

Donors will have one apheresis procedure and follow-up with any serious adverse events for 7 days.

Conditions: Healthy Volunteers
Being tested: Trima Accel System

What participants receive

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

Trima Accel SystemDevice
Platelet Apheresis Procedure

Study groups in NCT02684630
Study group	Role	What they receive
Single Platelet Product	Experimental	Healthy adult volunteer blood donors that qualify for a single unit platelet collection, with or without other components, will undergo plateletpheresis on the Trima Accel® Automated Blood Collection System (Trima Accel System). Receives: Device: Trima Accel System
Double Platelet Product	Experimental	Healthy adult volunteer blood donors that qualify for a double unit platelet collection, with or without other components, will undergo plateletpheresis on the Trima Accel® Automated Blood Collection System (Trima Accel System). Receives: Device: Trima Accel System

What is being measured

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

Donor Postprocedure Platelet Count Following Donation of Single Platelet Product
The primary endpoint for this study was the postprocedure participant platelet count for participants who have completed a single or double platelet collection. A procedure was a success if the participant's postprocedure platelet count was ≥ 100,000 platelets/μL. A procedure was a failure if the participant's postprocedure platelet count was < 100,000 platelets/μL.
Measured: The blood draw to determine postprocedure platelet count will occur ≥ 15 minutes after the end of apheresis
Donor Postprocedure Platelet Count Following Donation of Double Platelet Product
The primary endpoint for this study was the participant's postprocedure platelet count after completing a double platelet collection. A procedure was considered a success if the participant's postprocedure platelet count was ≥ 100,000 platelets/μL.
Measured: The blood draw to determine post procedure platelet count will occur ≥ 15 minutes after the end of apheresis

Timeline

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

28 Jan 201628 May 2016

First posted18 Feb 2016 (estimated)
Study start28 Jan 2016
Primary completion28 May 2016
Study completion28 May 2016

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: Basic science
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 131 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02684630
Sponsor's protocol ID: CTS-5054
Status last verified: Jun 2017
First submitted: 3 Nov 2015
Last updated: 12 Jul 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Healthy Volunteers trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter Study to Evaluate Modified Postcount Algorithm Software on the Trima Accel® System in Volunteer Blood Donors
ClinicalTrials.gov ID: NCT02684630
Acronym / sponsor ID: CTS-5054
Conditions: Healthy Volunteers
Study type: Interventional
Recruitment status: Completed
Enrolment: 131 participants (actual)
Lead sponsor: Terumo BCTIndustry (pharma, biotech, devices)
Study start: 28 Jan 2016
Primary completion: 28 May 2016 (actual)
Study completion: 28 May 2016 (actual)
First posted: 18 Feb 2016 (estimated)
Results: Posted 8 Jun 2017

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 optimize collected platelet yields in single and double platelet collections, while maintaining donor postplatelet count of >100,000/µL.

Detailed description

This is a prospective, open-label, non-randomized study to evaluate Trima Accel System modified postcount algorithm software.

Platelets will be collected according to the Trima Accel System Operator's Manual. Collection procedures will include those in which:

a single platelet product is collected
a double platelet product is collected, with or without other components.

Donors will have one apheresis procedure and follow-up with any serious adverse events for 7 days.

Study design

Primary purpose: Basic science
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Single Platelet Product	Experimental	Device: Trima Accel SystemHealthy adult volunteer blood donors that qualify for a single unit platelet collection, with or without other components, will undergo plateletpheresis on the Trima Accel® Automated Blood Collection System (Trima Accel System).
Double Platelet Product	Experimental	Device: Trima Accel SystemHealthy adult volunteer blood donors that qualify for a double unit platelet collection, with or without other components, will undergo plateletpheresis on the Trima Accel® Automated Blood Collection System (Trima Accel System).

Who may qualify

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

Key inclusion criteria (4 listed)

Age ≥ 18 years.
Meets Blood Center criteria for blood donation and is scheduled for an apheresis procedure that includes a single or double platelet product. These criteria are based on FDA Regulations and American Association of Blood Banks (AABB) Guidelines.
Appears to have adequate venous access to obtain a postprocedure platelet count.
Has given written informed consent.

Key exclusion criteria (1 listed)

Has undergone a splenectomy.

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 SystemPlatelet Apheresis Procedure	Device	Double Platelet Product, Single Platelet Product

Primary outcome

Donor Postprocedure Platelet Count Following Donation of Single Platelet Product
Time frame: The blood draw to determine postprocedure platelet count will occur ≥ 15 minutes after the end of apheresis
The primary endpoint for this study was the postprocedure participant platelet count for participants who have completed a single or double platelet collection. A procedure was a success if the participant's postprocedure platelet count was ≥ 100,000 platelets/μL. A procedure was a failure if the participant's postprocedure platelet count was < 100,000 platelets/μL.
Donor Postprocedure Platelet Count Following Donation of Double Platelet Product
Time frame: The blood draw to determine post procedure platelet count will occur ≥ 15 minutes after the end of apheresis
The primary endpoint for this study was the participant's postprocedure platelet count after completing a double platelet collection. A procedure was considered a success if the participant's postprocedure platelet count was ≥ 100,000 platelets/μL.

Results and safety

Results posted to the registry on 8 Jun 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Single Platelet Product	65	60
Double Platelet Product	63	60

Primary outcome: Donor Postprocedure Platelet Count Following Donation of Single Platelet Product

Time frame: The blood draw to determine postprocedure platelet count will occur ≥ 15 minutes after the end of apheresis. Count of participants. Unit: Participants

Measure	Single Platelet Product n = 60	Double Platelet Product n = 60
Success (n)	60	60
Failure (n)	0	0

Single Platelet Product: Simple sample proportion: 1.00

Population analysed: The Full Analysis Set (FAS) included all participants that completed the study and did not meet any of the protocol exclusion criteria. A participant could only have 1 product included in the FAS. The FAS was used to examine the primary and secondary endpoints.

Primary outcome: Donor Postprocedure Platelet Count Following Donation of Double Platelet Product

Time frame: The blood draw to determine post procedure platelet count will occur ≥ 15 minutes after the end of apheresis. Count of participants. Unit: Participants

Measure	Single Platelet Product n = 60	Double Platelet Product n = 60
Success (n)	60	60
Failure (n)	0	0

Double Platelet Product: Simple sample proportion: 1.00

Adverse events

Time frame: Adverse events that occurred during and up to 24 hours after the apheresis procedure were recorded.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Single Platelet Product	0 of 65 (0%)	5 of 65 (7.7%)	0 of 65
Double Platelet Product	0 of 63 (0%)	2 of 63 (3.2%)	0 of 63

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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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.

Heather Pidcoke, MD, PhD study director

Terumo BCT, Inc

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 4 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 12 Jul 2017. 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 8 Jun 2017). 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?

Donor Postprocedure Platelet Count Following Donation of Single Platelet Product (time frame: The blood draw to determine postprocedure platelet count will occur ≥ 15 minutes after the end of apheresis). 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?

On the ClinicalTrials.gov record for NCT02684630.

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 12 Jul 2017.