Blood SafetyMedicNCT02330081

Survival and Recovery of Radio-labeled Platelets Derived From Mirasol-treated Whole Blood

A study testing Mirasol treatment of whole blood in people with Blood Safety, run by Terumo BCTbio at 1 site in Norway.

Completed

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

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for: Blood Safety
What is being tested?: Mirasol treatment of whole blood
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 22 participants
Where: 1 siteNorway
Study dates: Apr 2015to Jul 2015
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 to 70 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Healthy adult subjects, who meet the inclusion criteria defined by the Blood Center for whole blood donation.
Age ≥ 18 and < 70 years
Able to commit to the study follow-up schedule.
Subjects must have adequate antecubital venous access for whole blood collection and follow-up blood draws.
Subjects of child-bearing potential (female or male) must agree to use effective contraception per site guideline or abstain from heterosexual intercourse during the course of the study.
Female of childbearing potential must be willing to take a pregnancy test prior to infusion of radiolabeled platelets.
Subjects must agree to report adverse events (AEs) during the required reporting period.

Who cannot join

Use of medications that interfere with platelet function within 48 hours of planned whole blood collection.
Participation currently, or within the last 12 months, in another investigational trial that would potentially interfere with the analysis of this investigation (e.g., pharmaceutical).
Inability to comply with the protocol in the opinion of the investigator.
Unable or unwilling to give informed consent.

Trial locations and contacts

1 site in 1 country.

Norway1 site

Haukeland University Hospital
Bergen, 2021

Other trials in Norway

About this study

Official title: Mirasol System for Whole Blood: Survival and Recovery of Radio-labeled Platelets Derived From Mirasol-treated Whole Blood in Healthy Volunteers

A total of twelve healthy volunteers will donate one unit of fresh whole blood. This unit will be treated with the Mirasol Pathogen Reduction Technology for Whole blood and then stored for 24h. At the end of storage, platelet concentrates will be separated from the unit, tested for key in vitro parameters and radiolabeled. On the same day (so 24h after the donation of whole blood), the volunteer will donate a fresh sample of whole blood. Platelets will be separated from this fresh sample and labeled with another radio-isotope. Then, the two radiolabeled platelet aliquots will be infused simultaneously and the recovery and survival of the two types of platelets will be measured.

Read the detailed description

The study will be a prospective, single-center, single-arm, intra-subject controlled, open-label design.

Subjects will donate one unit of fresh whole blood. This unit will be treated with the Mirasol PRT System for whole blood and then stored for 24 hours ± 1 hour at 22 ± 2°C. At the end of storage, platelet concentrates will be separated from the unit according to the Biomedical Excellence for Safer Transfusion (BEST) procedures. An aliquot will be removed from the platelet concentrates for testing and for radiolabeling and reinfusion. The platelets in Mirasol-treated whole blood will be tested for key in vitro parameters directly after treatment (Day 0) and at the end of storage (Day 1). Sterility testing will also be conducted on the stored units.

An aliquot of the platelet concentrate separated from each unit of stored Mirasol-treated whole blood will be radiolabeled with either 111Indium Oxine or 51Chromium, and autologously infused. An intra-subject control will be utilized as per the BEST guidelines for platelet radiolabeling procedures. On the day of infusion, the subject will donate a fresh sample of whole blood. Platelets will be separated from this fresh sample and labeled with the radio-isotope that was not used to label the subject's Mirasol-treated platelet sample. The two radiolabeled platelet aliquots (Mirasol-treated and fresh control) will be infused simultaneously, and the recovery and survival of the two types of platelets will be measured according to standard institutional practice.

Conditions: Blood Safety
Being tested: Mirasol treatment of whole blood
Keywords: pathogen reduction technology, whole blood, Platelets, Mirasol

What participants receive

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

Mirasol treatment of whole bloodDevice
Also called Mirasol pathogen reduction system, Mirasol system for whole blood
Subject will be infused with two products at the same time:
1. radio-labeled platelets derived from subject's stored whole blood which has been treated with Mirasol.
2. radio-labeled platelets derived from subject's untreated fresh whole blood.

Study groups in NCT02330081
Study group	Role	What they receive
Mirasol	Experimental	Subject will be infused with two products at the same time: 1. radio-labeled platelets derived from subjects stored whole blood which has been treated with Mirasol. 2. radio-labeled platelets derived from subjects untreated fresh whole blood. Receives: Device: Mirasol treatment of whole blood

What is being measured

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

Platelet 24-hour Relative Recovery
Relative recovery of platelets derived from Mirasol-treated whole blood (WB) units that had been stored for 24 ± 1 hours at 22 ± 2ºC, measured as a percentage of platelets derived from freshly collected WB from the same participant. Platelets were isolated from both Mirasol-treated WB and from fresh WB from the same participant, radiolabeled with either 111Indium or 51Chromium, and these 2 radiolabeled platelet samples (ie, 1 untreated, fresh and 1 Mirasol-treated, stored) were combined and reinfused back to the same participant.
Measured: 24 hours
Relative Platelet Survival
Mean survival time of platelets derived from Mirasol-treated whole blood (WB) units that had been stored for 24 ± 1 hours at 22 ± 2ºC as compared to the mean survival time of fresh platelets from the same donor, measured in hours. Platelets were isolated from both Mirasol-treated WB and from fresh WB from the same participant, radiolabeled with either 111Indium or 51Chromium, and these 2 radiolabeled platelet samples (ie, 1 untreated, fresh and 1 Mirasol-treated, stored) were combined and reinfused back to the same participant.
Measured: Days 1 through 10 post-infusion

Secondary outcomes (12)

in Vitro Characteristics of Whole Blood and Platelets Derived From Mirasol-treated Whole Blood - Hemoglobin
Measured: Day 0 post-collection, day 0 post-illumination, day 1 post-storage
in Vitro Characteristics of Whole Blood and Platelets Derived From Mirasol-treated Whole Blood - Hematocrit
Measured: Day 0 post-collection, day 0 post-illumination, day 1 post-storage
in Vitro Characteristics of Whole Blood and Platelets Derived From Mirasol-treated Whole Blood - White Blood Cells
Measured: Day 0 post-collection, day 0 post-illumination, day 1 post-storage
in Vitro Characteristics of Whole Blood and Platelets Derived From Mirasol-treated Whole Blood - Platelets
Measured: Day 0 post-collection, day 0 post-illumination, day 1 post-storage
in Vitro Characteristics of Whole Blood and Platelets Derived From Mirasol-treated Whole Blood - pH
pH is a measure of the acidity or alkalinity of a solution, numerically equal to 7 for neutral solutions, increasing with increasing alkalinity and decreasing with increasing acidity. The pH scale commonly in use ranges from 0 to 14
Measured: Day 0 post-collection, day 0 post-illumination, day 1 post-storage
in Vitro Characteristics of Whole Blood and Platelets Derived From Mirasol-treated Whole Blood - CO2
Measured: Day 0 post-collection, day 0 post-illumination, day 1 post-storage
in Vitro Characteristics of Whole Blood and Platelets Derived From Mirasol-treated Whole Blood - pO2
Measured: Day 0 post-collection, day 0 post-illumination, day 1 post-storage
in Vitro Characteristics of Whole Blood and Platelets Derived From Mirasol-treated Whole Blood - Potassium
Measured: Day 0 post-collection, day 0 post-illumination, day 1 post-storage
in Vitro Characteristics of Whole Blood and Platelets Derived From Mirasol-treated Whole Blood - Glucose
Measured: Day 0 post-collection, day 0 post-illumination, day 1 post-storage
in Vitro Characteristics of Whole Blood and Platelets Derived From Mirasol-treated Whole Blood - Lactate
Measured: Day 0 post-collection, day 0 post-illumination, day 1 post-storage
in Vitro Characteristics of Whole Blood and Platelets Derived From Mirasol-treated Whole Blood - Hemolysis
Hemolysis is the rupture or destruction of red blood cells (RBCs), which releases hemoglobin from inside the RBCs into the plasma (where it is called "free hemoglobin"). Hemolysis is measured as the percentage of free hemoglobin compared to the total hemoglobin in a blood sample.
Measured: Day 0 post-collection, day 0 post-illumination, day 1 post-storage
in Vitro Characteristics of Whole Blood and Platelets Derived From Mirasol-treated Whole Blood - Plasma Free Hemoglobin
Measured: Day 0 post-collection, day 0 post-illumination, day 1 post-storage

Timeline

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

Apr 2015Jul 2015

First posted1 Jan 2015 (estimated)
Study startApr 2015
Primary completionJul 2015
Study completionJul 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 SafetyStudies 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: Device feasibility
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 22 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02330081
Sponsor's protocol ID: CTS-0081
Acronym: Medic
Status last verified: May 2019
First submitted: 30 Dec 2014
Last updated: 12 Jun 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

Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingObservational study
A Study in Children and, Adults With Congenital Thrombotic Thrombocytopenic Purpura (cTTP) Treated With Adzynma
Thrombotic Thrombocytopenic Purpura (TTP)
Active, not recruitingPhase 2
A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB)
Chronic Hepatitis B Virus Infection, Hepatitis B
RecruitingPhase 3
A Phase III Renal Outcomes and Cardiovascular Mortality Study to Investigate the Efficacy and Safety of Baxdrostat in Combination With Dapagliflozin in Participants With Chronic Kidney Disease and High Blood Pressure
Chronic Kidney Disease and Hypertension
RecruitingPhase 3
rhTPO for Thrombocytopenia in Chronic Liver Disease Patients Undergoing Elective Invasive Procedures.
Thrombocytopenia Associated With Chronic Liver Disease

All Blood Safety trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Mirasol System for Whole Blood: Survival and Recovery of Radio-labeled Platelets Derived From Mirasol-treated Whole Blood in Healthy Volunteers
ClinicalTrials.gov ID: NCT02330081
Acronym / sponsor ID: Medic / CTS-0081
Conditions: Blood Safety
Keywords: pathogen reduction technology, whole blood, Platelets, Mirasol
Study type: Interventional
Recruitment status: Completed
Enrolment: 22 participants (actual)
Lead sponsor: Terumo BCTbioIndustry (pharma, biotech, devices)
Collaborators: United States Department of Defense
Study start: Apr 2015
Primary completion: Jul 2015 (actual)
Study completion: Jul 2015 (actual)
First posted: 1 Jan 2015 (estimated)
Results: Posted 31 May 2019

Clinical summary

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

Detailed description

The study will be a prospective, single-center, single-arm, intra-subject controlled, open-label design.

Study design

Primary purpose: Device feasibility
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Mirasol	Experimental	Device: Mirasol treatment of whole bloodSubject will be infused with two products at the same time: 1. radio-labeled platelets derived from subjects stored whole blood which has been treated with Mirasol. 2. radio-labeled platelets derived from subjects untreated fresh whole blood.

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Healthy adult subjects, who meet the inclusion criteria defined by the Blood Center for whole blood donation.
Age ≥ 18 and < 70 years
Able to commit to the study follow-up schedule.
Subjects must have adequate antecubital venous access for whole blood collection and follow-up blood draws.
Subjects of child-bearing potential (female or male) must agree to use effective contraception per site guideline or abstain from heterosexual intercourse during the course of the study.

Key exclusion criteria (4 listed)

Use of medications that interfere with platelet function within 48 hours of planned whole blood collection.
Participation currently, or within the last 12 months, in another investigational trial that would potentially interfere with the analysis of this investigation (e.g., pharmaceutical).
Inability to comply with the protocol in the opinion of the investigator.
Unable or unwilling to give informed consent.

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 treatment of whole bloodAlso: Mirasol pathogen reduction system, Mirasol system for whole bloodSubject will be infused with two products at the same time: 1. radio-labeled platelets derived from subject's stored whole blood which has been treated with Mirasol. 2. radio-labeled platelets derived from subject's untreated fresh whole blood.	Device	Mirasol

Primary outcome

Platelet 24-hour Relative Recovery
Time frame: 24 hours
Relative recovery of platelets derived from Mirasol-treated whole blood (WB) units that had been stored for 24 ± 1 hours at 22 ± 2ºC, measured as a percentage of platelets derived from freshly collected WB from the same participant. Platelets were isolated from both Mirasol-treated WB and from fresh WB from the same participant, radiolabeled with either 111Indium or 51Chromium, and these 2 radiolabeled platelet samples (ie, 1 untreated, fresh and 1 Mirasol-treated, stored) were combined and reinfused back to the same participant.
Relative Platelet Survival
Time frame: Days 1 through 10 post-infusion
Mean survival time of platelets derived from Mirasol-treated whole blood (WB) units that had been stored for 24 ± 1 hours at 22 ± 2ºC as compared to the mean survival time of fresh platelets from the same donor, measured in hours. Platelets were isolated from both Mirasol-treated WB and from fresh WB from the same participant, radiolabeled with either 111Indium or 51Chromium, and these 2 radiolabeled platelet samples (ie, 1 untreated, fresh and 1 Mirasol-treated, stored) were combined and reinfused back to the same participant.

12 secondary outcomes

in Vitro Characteristics of Whole Blood and Platelets Derived From Mirasol-treated Whole Blood - Hemoglobin
Time frame: Day 0 post-collection, day 0 post-illumination, day 1 post-storage
in Vitro Characteristics of Whole Blood and Platelets Derived From Mirasol-treated Whole Blood - Hematocrit
Time frame: Day 0 post-collection, day 0 post-illumination, day 1 post-storage
in Vitro Characteristics of Whole Blood and Platelets Derived From Mirasol-treated Whole Blood - White Blood Cells
Time frame: Day 0 post-collection, day 0 post-illumination, day 1 post-storage
in Vitro Characteristics of Whole Blood and Platelets Derived From Mirasol-treated Whole Blood - Platelets
Time frame: Day 0 post-collection, day 0 post-illumination, day 1 post-storage
in Vitro Characteristics of Whole Blood and Platelets Derived From Mirasol-treated Whole Blood - pH
Time frame: Day 0 post-collection, day 0 post-illumination, day 1 post-storage
in Vitro Characteristics of Whole Blood and Platelets Derived From Mirasol-treated Whole Blood - CO2
Time frame: Day 0 post-collection, day 0 post-illumination, day 1 post-storage
in Vitro Characteristics of Whole Blood and Platelets Derived From Mirasol-treated Whole Blood - pO2
Time frame: Day 0 post-collection, day 0 post-illumination, day 1 post-storage
in Vitro Characteristics of Whole Blood and Platelets Derived From Mirasol-treated Whole Blood - Potassium
Time frame: Day 0 post-collection, day 0 post-illumination, day 1 post-storage
in Vitro Characteristics of Whole Blood and Platelets Derived From Mirasol-treated Whole Blood - Glucose
Time frame: Day 0 post-collection, day 0 post-illumination, day 1 post-storage
in Vitro Characteristics of Whole Blood and Platelets Derived From Mirasol-treated Whole Blood - Lactate
Time frame: Day 0 post-collection, day 0 post-illumination, day 1 post-storage
in Vitro Characteristics of Whole Blood and Platelets Derived From Mirasol-treated Whole Blood - Hemolysis
Time frame: Day 0 post-collection, day 0 post-illumination, day 1 post-storage
in Vitro Characteristics of Whole Blood and Platelets Derived From Mirasol-treated Whole Blood - Plasma Free Hemoglobin
Time frame: Day 0 post-collection, day 0 post-illumination, day 1 post-storage

Results and safety

Results posted to the registry on 31 May 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	22	14

Primary outcome: Platelet 24-hour Relative Recovery

Time frame: 24 hours. Mean (95% Confidence Interval). Unit: Percentage of platelet count

Measure	Test Platelets From Mirasol-treated Whole Blood n = 14	Control Platelets n = 14
Value	43.31 (37.93 to 48.69)	52.01 (45.22 to 58.80)

Test Platelets From Mirasol-treated Whole Blood vs Control Platelets: Risk Ratio (RR): 83.3

Population analysed: Per Protocol Population = all subjects in the mITT Population who met all of the inclusion and none of the exclusion criteria at enrollment, had no concurrent illness or notable signs/symptoms during the 24 hours prior to reinfusion, had completed all postinfusion blood sampling for recovery and survival calculations and had no protocol violations.

Primary outcome: Relative Platelet Survival

Time frame: Days 1 through 10 post-infusion. Mean (95% Confidence Interval). Unit: hours

Measure	Test Platelets From Mirasol-treated Whole Blood n = 14	Control Platelets n = 14
Value	152.9 (136.4 to 169.4)	188.8 (175.2 to 202.3)

Test Platelets From Mirasol-treated Whole Blood vs Control Platelets: Mean Ratio Survival Time: 81

12 secondary outcomes are reported in the full results.

Adverse events

Time frame: 10 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Mirasol	0 of 22 (0%)	10 of 22 (45.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Blood Safety

Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingObservational study
A Study in Children and, Adults With Congenital Thrombotic Thrombocytopenic Purpura (cTTP) Treated With Adzynma
Thrombotic Thrombocytopenic Purpura (TTP)
Active, not recruitingPhase 2
A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB)
Chronic Hepatitis B Virus Infection, Hepatitis B
RecruitingPhase 3
A Phase III Renal Outcomes and Cardiovascular Mortality Study to Investigate the Efficacy and Safety of Baxdrostat in Combination With Dapagliflozin in Participants With Chronic Kidney Disease and High Blood Pressure
Chronic Kidney Disease and Hypertension
RecruitingPhase 3
rhTPO for Thrombocytopenia in Chronic Liver Disease Patients Undergoing Elective Invasive Procedures.
Thrombocytopenia Associated With Chronic Liver Disease

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.

Ray Goodrich, PhD study chair

Terumo BCT VP Science, Clinical and Laboratory

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

Questions about this trial

What is this clinical trial studying?

A study testing Mirasol treatment of whole blood in people with Blood Safety, run by Terumo BCTbio at 1 site in Norway.

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 4 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 Jun 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 Norway. 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 31 May 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?

Platelet 24-hour Relative Recovery (time frame: 24 hours). 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 NCT02330081.

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 Jun 2019.