HealthyPhase 1IMPROVENCT00742001

Feasibility Study of Mirasol-Treated Whole Blood Red Cell Recovery and Survival

A Phase 1 study testing Mirasol System for Whole Blood. in people with Healthy, run by Terumo BCTbio at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Feasibility trial to evaluate recovery and survival of red blood cells (RBCs) from Mirasol-treated whole blood Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Mirasol System for Whole Blood.
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 12 participants
Where: 1 siteUnited States
Study dates: 10 Sep 2008to 16 Dec 2008
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

healthy adults who meet AABB (formerly known as the American Association of Blood Banks) criteria for whole blood donation
females incapable of becoming pregnant
males agreeing to use contraception during trial

Who cannot join

pregnancy or nursing
abnormal medical history (bleeding disorders, anemia, myocardial ischemia, uncontrolled hypertension, heart disease, epilepsy)
major surgery
use of drugs affecting coagulation or RBC function
recent participation in other trials which may confound results

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Cincinnati, Hoxworth Blood Center
Cincinnati, Ohio, 45267

Other trials in United States

About this study

Official title: IMPROVE: Inactivation of Whole Blood With Mirasol (R): Performance in Red Blood Cells, Platelets and Plasma Investigation

Feasibility trial to evaluate recovery and survival of red blood cells (RBCs) from Mirasol-treated whole blood

Read the detailed description

Radiolabeling of red blood cells (RBCs) followed by infusion back to the donor is commonly used to test the quality of RBCs in a person. By measuring the level of radioisotope in a blood sample, these tests evaluate what percentage of the RBCs remain in the bloodstream after 24 hours (recovery) and can predict how long the RBCs will remain in circulation (survival). The IMPROVE trial is a feasibility trial to evaluate these parameters in RBCs obtained from whole blood units that have been treated with the Mirasol System.

Conditions: Healthy
Being tested: Mirasol System for Whole Blood.
Keywords: red blood cells, transfusion, recovery, feasibility, white blood cell inactivation

What participants receive

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

Mirasol System for Whole Blood.Biological
Also called Mirasol System, Mirasol
Treatment of whole blood with the Mirasol system at 3 experimental illumination energies for testing of autologous RBC recovery and survival in healthy subjects

Study groups in NCT00742001
Study group	Role	What they receive
Mirasol Illumination Dose #1	Experimental	Whole blood units treated with Mirasol at Illumination dose #1 (A1) of 22 Joules per milliliter of red blood cells (J/mL RBCs) Receives: Biological: Mirasol System for Whole Blood.
Mirasol Illumination Dose #2	Experimental	Whole Blood units treated with Mirasol at Illumination dose #2 (A2) of 33 J/mL RBCs Receives: Biological: Mirasol System for Whole Blood.
Mirasol Illumination Dose #3	Experimental	Whole Blood units treated with Mirasol at Illumination dose #3 (A3) of 44 J/mL RBCs Receives: Biological: Mirasol System for Whole Blood.

What is being measured

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

Red Blood Cell (RBC) Recovery
The 24-hour recovery calculation was conducted to evaluate the percentage of labeled RBCs remaining in the circulation 24 hours after re-infusion of the cells, as compared to Time 0 measurements (time of re-infusion). FDA requires at least 75% recovery for new RBC processes.
Measured: 24-hour post autologous infusion of RBCs

Secondary outcomes (2)

Predicted Total Lifespan of Red Blood Cells (RBCs), Based on 28-day RBC Survival
The objective of measuring 28-day survival was to identify the potential total lifespan of labeled RBCs in circulation. Normal, native RBCs remain in circulation for a maximum of approximately 120 days; by using the 51Cr half-life of approximately 28 days, and its elution rate from labeled RBCs, the survival of the labeled cells can be predicted.
Measured: 28-days post autologous infusion of RBCs
Count of Participants With Serious Adverse Events (SAE)
Measured: 28-days post autologous infusion of RBCs

Timeline

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

10 Sep 200816 Dec 2008

First posted27 Aug 2008 (estimated)
Study start10 Sep 2008
Primary completion20 Nov 2008
Study completion16 Dec 2008

Why it stopped: An endpoint difference between 3 energies was not observed at interim analysis

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 HealthyStudies 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: Other
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00742001
Sponsor's protocol ID: CTS-0040
Acronym: IMPROVE
Status last verified: Aug 2019
First submitted: 25 Aug 2008
Last updated: 28 Aug 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: 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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Study at a glance

From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: IMPROVE: Inactivation of Whole Blood With Mirasol (R): Performance in Red Blood Cells, Platelets and Plasma Investigation
ClinicalTrials.gov ID: NCT00742001
Acronym / sponsor ID: IMPROVE / CTS-0040
Conditions: Healthy
Keywords: red blood cells, transfusion, recovery, feasibility, white blood cell inactivation
Phase: Phase 1
Study type: Interventional
Recruitment status: TerminatedReason stopped: An endpoint difference between 3 energies was not observed at interim analysis
Enrolment: 12 participants (actual)
Lead sponsor: Terumo BCTbioIndustry (pharma, biotech, devices)
Collaborators: United States Department of Defense
Study start: 10 Sep 2008 (actual)
Primary completion: 20 Nov 2008 (actual)
Study completion: 16 Dec 2008 (actual)
First posted: 27 Aug 2008 (estimated)
Results: Posted 28 Aug 2019

Clinical summary

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

Feasibility trial to evaluate recovery and survival of red blood cells (RBCs) from Mirasol-treated whole blood

Detailed description

Study design

Primary purpose: Other
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 3

Arm	Type	Receives
Mirasol Illumination Dose #1	Experimental	Biological: Mirasol System for Whole Blood.Whole blood units treated with Mirasol at Illumination dose #1 (A1) of 22 Joules per milliliter of red blood cells (J/mL RBCs)
Mirasol Illumination Dose #2	Experimental	Biological: Mirasol System for Whole Blood.Whole Blood units treated with Mirasol at Illumination dose #2 (A2) of 33 J/mL RBCs
Mirasol Illumination Dose #3	Experimental	Biological: Mirasol System for Whole Blood.Whole Blood units treated with Mirasol at Illumination dose #3 (A3) of 44 J/mL RBCs

Who may qualify

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

Key inclusion criteria (3 listed)

healthy adults who meet AABB (formerly known as the American Association of Blood Banks) criteria for whole blood donation
females incapable of becoming pregnant
males agreeing to use contraception during trial

Key exclusion criteria (5 listed)

pregnancy or nursing
abnormal medical history (bleeding disorders, anemia, myocardial ischemia, uncontrolled hypertension, heart disease, epilepsy)
major surgery
use of drugs affecting coagulation or RBC function
recent participation in other trials which may confound results

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
Mirasol System for Whole Blood.Also: Mirasol System, MirasolTreatment of whole blood with the Mirasol system at 3 experimental illumination energies for testing of autologous RBC recovery and survival in healthy subjects	Biological	Mirasol Illumination Dose #1, Mirasol Illumination Dose #2, Mirasol Illumination Dose #3

Primary outcome

Red Blood Cell (RBC) Recovery
Time frame: 24-hour post autologous infusion of RBCs
The 24-hour recovery calculation was conducted to evaluate the percentage of labeled RBCs remaining in the circulation 24 hours after re-infusion of the cells, as compared to Time 0 measurements (time of re-infusion). FDA requires at least 75% recovery for new RBC processes.

2 secondary outcomes

Predicted Total Lifespan of Red Blood Cells (RBCs), Based on 28-day RBC Survival
Time frame: 28-days post autologous infusion of RBCs
Count of Participants With Serious Adverse Events (SAE)
Time frame: 28-days post autologous infusion of RBCs

Results and safety

Results posted to the registry on 28 Aug 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Mirasol Illumination Dose #1 (A1)	4	4
Mirasol Illumination Dose #2 (A2)	4	4
Mirasol Illumination Dose #3 (A3)	4	3

Primary outcome: Red Blood Cell (RBC) Recovery

Time frame: 24-hour post autologous infusion of RBCs. Mean (Standard Deviation). Unit: percentage of recovered RBCs

Measure	Mirasol Illumination Dose #1 (A1) n = 4	Mirasol Illumination Dose #2 (A2) n = 4	Mirasol Illumination Dose #3 (A3) n = 3
Value	77.8 (3.4)	70.5 (7.5)	68.1 (6.3)

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: From the time of autologous RBC re-infusion until study completion (28 days). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Mirasol Illumination Dose #1 (A1)	0 of 4 (0%)	1 of 4 (25%)	0 of 4
Mirasol Illumination Dose #2 (A2)	0 of 4 (0%)	2 of 4 (50%)	0 of 4
Mirasol Illumination Dose #3 (A3)	0 of 4 (0%)	2 of 4 (50%)	0 of 4

Limitations and caveats (from the sponsor): Two major limitations to the interpretation of these data. 1)the small sample size limited the interpretation of some of the data. 2)the high degree of inter-subject variability further limits the interpretation of potential trends seen in the data.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Jose Cancelas-Perez, M.D, Ph.D principal investigator

University of Cincinnati, Hoxworth Blood Center

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

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Mirasol System for Whole Blood. in people with Healthy, run by Terumo BCTbio at 1 site 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 3 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: stopped early, as of the sponsor's last update on 28 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 Aug 2019). 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 (RBC) Recovery (time frame: 24-hour post autologous infusion of RBCs). 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 NCT00742001.

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 28 Aug 2019.