Focus of Study: Radiolabel Recovery and Survival of RBCsPhase 1IMPROVEIINCT01907906
Inactivation of Whole Blood With Mirasol
A Phase 1 study testing Mirasol System for Whole Blood in people with Focus of Study: Radiolabel Recovery and Survival of RBCs, run by Terumo BCTbio at 2 sites in United States.
Trial summary
The purpose of this study is to evaluate radiolabeled recovery and survival of autologous red blood cells (RBC), derived from Mirasol-treated fresh whole blood (WB), stored as leukoreduced packed RBC (LR-pRBC), and re-infused in healthy adult subjects Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Focus of Study: Radiolabel Recovery and Survival of RBCs
- What is being tested?
- Mirasol System for Whole Blood
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2013to May 2014
- 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
- Eligible whole blood donor
- Age ≥ 18 years, of either sex
- Able to commit to the study follow-up schedule
- Subjects must have adequate bilateral antecubital venous access for WB collection and follow-up blood draws
- Negative screening test panel for infectious diseases
- Subjects of child-bearing potential (female or male) must agree to use effective contraceptive during the course of the study per site guidelines
Show all 14Show fewer
- Subjects must agree to report adverse events (AEs) during the required reporting period
- Negative direct antiglobulin test (DAT) with subject's RBC
- Negative indirect antiglobulin test (IAT) with subject's serum
- Inclusion for radiolabeled reinfusion of LR-pRBC on Day 21 (evaluated the day of, prior to, reinfusion):
- Maintenance of healthy status
- Negative direct antiglobulin test (DAT) with subject's RBC (fresh)
- Negative indirect antiglobulin test (IAT) with subject's serum (fresh) versus autologous stored LR-pRBC
- Negative serum or urine pregnancy test in females
Who cannot join
- Any serious medical illness and/or therapy, including: abnormal bleeding episodes, clotting or bleeding disorder, evidence of anemia, myocardial infarction, uncontrolled hypertension, heart disease, surgery with bleeding complications, epilepsy or any major surgery (with general or spinal anesthesia) within the last 6 months
- Pregnant or nursing females; For women of childbearing potential, negative serum or urine pregnancy tests at the time of WB donation and before the reinfusion are required
- Unable to give informed consent
- 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)
- Have received an accumulated radiation dose that would exclude them from the study according to the local radiation safety limits established by each institution
- Inability to comply with the protocol in the opinion of the investigator
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Hoxworth Blood Center
Cincinnati, Ohio, 45267
Puget Sound Blood Center
Seattle, Washington, 98104
About this study
Official title: Inactivation of Whole Blood With Mirasol : Performance in Red Blood Cells in Healthy Volunteers
The purpose of this study is to evaluate radiolabeled recovery and survival of autologous red blood cells (RBC), derived from Mirasol-treated fresh whole blood (WB), stored as leukoreduced packed RBC (LR-pRBC), and re-infused in healthy adult subjects
Read the detailed description
This is a feasibility level study conducted to assess the recovery and survival of autologous, radiolabeled leukoreduced packed red blood cells (LR-pRBC) derived from fresh whole blood (WB) units that have been treated with the Mirasol System for Whole Blood (Mirasol System) and stored for 21 days at 1-6°C.1
- Being tested
- Mirasol System for Whole Blood
- Keywords
- Pathogen reduction technology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mirasol System for Whole BloodDevice
Also called Pathogen Reduction Technology
LR-pRBC units derived from WB will be treated with the Mirasol System. Treatment with the Mirasol System requires riboflavin to be mixed into the whole blood unit, which is then exposed to ultra violet (UV) light for a period of time; approximately an hour.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Mirasol-treated WB then untreated WB | Experimental | Screening Period (14 days); Treatment Period 1 (49 days): Donation of WB treated with Mirasol System for Whole Blood on Day 0, LR-pRBCs manufactured \& stored 21 days, radiolabeled RBCs reinfused on Day 21 and samples collected over 28 days (Days 21-49); WB Donation Deferral Period (35-49 days); Treatment Period 2 (49 days): Donation of WB, UNTREATED on Day 0, LR-pRBCs manufactured \& stored 21 days, radiolabeled RBCs reinfused on Day 21 and samples collected over 28 days (Days 21-49) Study Exit on Treatment Period 2, Day 49 Receives: Device: Mirasol System for Whole Blood |
| Arm 2: Untreated WB then Mirasol-treated WB | Experimental | Screening Period (14 days); Treatment Period 1 (49 days): Donation of WB, UNTREATED on Day 0, LR-pRBCs manufactured \& stored 21 days, radiolabeled RBCs reinfused on Day 21 and samples collected over 28 days (Days 21-49); WB Donation Deferral Period (35-49 days); Treatment Period 2 (49 days): Donation of WB treated with Mirasol System for Whole Blood on Day 0, LR-pRBCs manufactured \& stored 21 days, radiolabeled RBCs reinfused on Day 21 and samples collected over 28 days (Days 21-49) Study Exit on Treatment Period 2, Day 49 Receives: Device: 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) 24-Hour Recovery
To evaluate, as per FDA criteria, the 24-hour post transfusion RBC recovery in healthy adult subjects of leuko-reduced packed red blood cells (LR-pRBC) that have been derived from Mirasol-treated fresh WB units and stored at 1 to 6°C for 21 days.
24-hour RBC Recovery is a measure of the % of RBCs that are still functioning 24 hours after they have been reinfused back into the donor following storage over 21 days.
Measured: 24 hours
Secondary outcomes (36)
Red Blood Cell (RBC) Survival by Product
Assessment of linear \& exponential RBC survival and half-life (T50) over 28 days for RBCs derived from Mirasol-treated WB versus RBCs derived from untreated WB.
Measured: 28 days
Area Under the Curve (AUC) of Red Blood Cell (RBC) Survival
Assessment of AUC of RBC survival over 28 days for RBCs derived from Mirasol-treated Whole Blood (WB) versus RBCs derived from untreated WB.
Measured: 28 days
Spearman's Correlation Coefficients: 24-Hour Red Blood Cell (RBC) Recovery (%) With Hemolysis (%)
Spearman's Correlation Coefficients comparing 24-Hour RBC Recovery (%) with Hemolysis (%) in packed Red Blood Cells (pRBCs) derived from Mirasol-treated whole blood (WB) versus pRBCs derived from untreated WB
Measured: 24 hours
Spearman's Correlation Coefficients: 24-Hour RBC Recovery (%) With Adenosine Triphosphate (ATP) (µmol/g Hgb)
Spearman's Correlation Coefficients comparing 24-Hour RBC Recovery (%) with ATP (µmol/g Hgb) in packed Red Blood Cells (pRBCs) derived from Mirasol-treated whole blood (WB) versus pRBCs derived from untreated WB
Measured: 24 hours
Spearman's Correlation Coefficients: 24-Hour RBC Recovery (%) pCO2 (mmHg at 37° C)
Spearman's Correlation Coefficients comparing 24-Hour RBC Recovery (%) with pCO2 (mmHg at 37° C) in packed Red Blood Cells (pRBCs) derived from Mirasol-treated whole blood (WB) versus pRBCs derived from untreated WB
Measured: 24 hours
Spearman's Correlation Coefficients: Linear T50 (Days) With Hemolysis (%)
Spearman's Correlation Coefficients comparing Linear T50 (Days) with each of Hemolysis (%) in packed Red Blood Cells (pRBCs) derived from Mirasol-treated whole blood (WB) versus pRBCs derived from untreated WB
Measured: 28 days
Spearman's Correlation Coefficients: Linear T50 (Days) With Adenosine Triphosphate (ATP) (µmol/g Hgb)
Spearman's Correlation Coefficients comparing Linear T50 (Days) with ATP (µmol/g Hgb) in packed Red Blood Cells (pRBCs) derived from Mirasol-treated whole blood (WB) versus pRBCs derived from untreated WB
Measured: 28 days
Spearman's Correlation Coefficients: Linear T50 (Days) With pCO2 (mmHg at 37° C)
Spearman's Correlation Coefficients comparing Linear T50 (Days) with pCO2 (mmHg at 37° C) in packed Red Blood Cells (pRBCs) derived from Mirasol-treated whole blood (WB) versus pRBCs derived from untreated WB
Measured: 28 days
Neoantigenicity - Day 21 Direct Antigen Test (DAT)
DAT testing of Red Blood Cells (RBCs) via Anti-immunoglobulin G (Anti-IgG) and Anti Complement Component 3 (Anti-C3) as derived from Mirasol-treated whole blood (WB) versus untreated WB conducted on Day 21 of both Treatment Periods 1 and 2. Number of positive results (indicating a new antigen formation) were recorded.
Measured: Day 21
Neoantigenicity - Day 21 Indirect Antigen Test (IAT)
Day 21 IAT testing of RBCs via LISS-15, Anti-IgG and C3 as derived from Mirasol-treated WB versus untreated WB. Number of positive results (indicating antibody formation to a new antigen) were recorded.
Measured: Day 21 of Treatment Periods 1 and 2
Neoantigenicity - Day 42 Direct Antigen Test (DAT)
DAT testing of RBCs via Anti-IgG and Anti-C3 as derived from Mirasol-treated WB versus untreated WB. Number of positive results (indicating a new antigen formation) were recorded.
Measured: Day 42 of Treatment Periods 1 and 2
Neoantigenicity - Day 42 Indirect Antigen Test (IAT)
IAT testing of RBCs via low ionic strength solution (LISS-15), Anti-IgG and C3 as derived from Mirasol-treated WB versus untreated WB. Number of positive results (indicating antibody formation to a new antigen) were recorded.
Measured: Day 42 of Treatment Periods 1 and 2
In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Hematocrit (%)
Measured: Day 0
In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Hematocrit (%)
Measured: Day 21
In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - ATP
Measured: Day 0
In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - ATP
Measured: Day 21
In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - White Blood Cell (WBC) Count
Measured: Day 0
In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - White Blood Cell (WBC) Count
Measured: Day 21
In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Total Hemoglobin
Measured: Day 0
In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Total Hemoglobin
Measured: Day 21
In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - pH (at 37° C)
Measured: Day 0
In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - pH (at 37° C)
Measured: Day 21
In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - pCO2 (mmHg at 37° C)
Measured: Day 0
In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - pCO2 (mmHg at 37° C)
Measured: Day 21
In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Potassium
Measured: Day 0
In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Potassium
Measured: Day 21
In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Glucose
Measured: Day 0
In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Glucose
Measured: Day 21
In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Lactate
Measured: Day 0
In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Lactate
Measured: Day 21
In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Supernatant Hgb
Measured: Day 0
In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Supernatant Hgb
Measured: Day 21
In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - 2,3-diphosphoglycerate (DPG)
Measured: Day 0
In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - 2,3-diphosphoglycerate (DPG)
Measured: Day 21
In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Hemolysis (%)
Measured: Day 0
In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Hemolysis (%)
Measured: Day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2013 (estimated)
- Study startJun 2013
- Primary completionMay 2014
- Study completionMay 2014
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 Focus of Study: Radiolabel Recovery and Survival of RBCsStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Terumo BCTbio
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- U.S. Army Medical Research and Development Command
- Responsible party
- Sponsor
- Investigators
- Raymond P Goodrich, PhD, Study director, TerumoBCT Biotechnologies
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01907906
- Sponsor's protocol ID
- CTS-0080
- Other IDs
- ERMS#12308001
- Acronym
- IMPROVEII
- Status last verified
- Jul 2015
- First submitted
- 20 Jun 2013
- Last updated
- 18 Aug 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inactivation of Whole Blood With Mirasol : Performance in Red Blood Cells in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01907906
- Acronym / sponsor ID
- IMPROVEII / CTS-0080
- Keywords
- Pathogen reduction technology
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Terumo BCTbioIndustry (pharma, biotech, devices)
- Collaborators
- U.S. Army Medical Research and Development Command
- Study start
- Jun 2013
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 25 Jul 2013 (estimated)
- Results
- Posted 27 Jul 2015
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 radiolabeled recovery and survival of autologous red blood cells (RBC), derived from Mirasol-treated fresh whole blood (WB), stored as leukoreduced packed RBC (LR-pRBC), and re-infused in healthy adult subjects
Detailed description
This is a feasibility level study conducted to assess the recovery and survival of autologous, radiolabeled leukoreduced packed red blood cells (LR-pRBC) derived from fresh whole blood (WB) units that have been treated with the Mirasol System for Whole Blood (Mirasol System) and stored for 21 days at 1-6°C.1
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Mirasol-treated WB then untreated WB | Experimental | Device: Mirasol System for Whole BloodScreening Period (14 days); Treatment Period 1 (49 days): Donation of WB treated with Mirasol System for Whole Blood on Day 0, LR-pRBCs manufactured \& stored 21 days, radiolabeled RBCs reinfused on Day 21 and samples collected over 28 days (Days 21-49); WB Donation Deferral Period (35-49 days); Treatment Period 2 (49 days): Donation of WB, UNTREATED on Day 0, LR-pRBCs manufactured \& stored 21 days, radiolabeled RBCs reinfused on Day 21 and samples collected over 28 days (Days 21-49) Study Exit on Treatment Period 2, Day 49 |
| Arm 2: Untreated WB then Mirasol-treated WB | Experimental | Device: Mirasol System for Whole BloodScreening Period (14 days); Treatment Period 1 (49 days): Donation of WB, UNTREATED on Day 0, LR-pRBCs manufactured \& stored 21 days, radiolabeled RBCs reinfused on Day 21 and samples collected over 28 days (Days 21-49); WB Donation Deferral Period (35-49 days); Treatment Period 2 (49 days): Donation of WB treated with Mirasol System for Whole Blood on Day 0, LR-pRBCs manufactured \& stored 21 days, radiolabeled RBCs reinfused on Day 21 and samples collected over 28 days (Days 21-49) Study Exit on Treatment Period 2, Day 49 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Eligible whole blood donor
- Age ≥ 18 years, of either sex
- Able to commit to the study follow-up schedule
- Subjects must have adequate bilateral antecubital venous access for WB collection and follow-up blood draws
- Negative screening test panel for infectious diseases
Key exclusion criteria (6 listed)
- Any serious medical illness and/or therapy, including: abnormal bleeding episodes, clotting or bleeding disorder, evidence of anemia, myocardial infarction, uncontrolled hypertension, heart disease, surgery with bleeding complications, epilepsy or any major surgery (with general or spinal anesthesia) within the last 6 months
- Pregnant or nursing females; For women of childbearing potential, negative serum or urine pregnancy tests at the time of WB donation and before the reinfusion are required
- Unable to give informed consent
- 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)
- Have received an accumulated radiation dose that would exclude them from the study according to the local radiation safety limits established by each institution
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 BloodAlso: Pathogen Reduction TechnologyLR-pRBC units derived from WB will be treated with the Mirasol System. Treatment with the Mirasol System requires riboflavin to be mixed into the whole blood unit, which is then exposed to ultra violet (UV) light for a period of time; approximately an hour. | Device | Arm 1: Mirasol-treated WB then untreated WB, Arm 2: Untreated WB then Mirasol-treated WB |
Primary outcome
Red Blood Cell (RBC) 24-Hour Recovery
Time frame: 24 hours
To evaluate, as per FDA criteria, the 24-hour post transfusion RBC recovery in healthy adult subjects of leuko-reduced packed red blood cells (LR-pRBC) that have been derived from Mirasol-treated fresh WB units and stored at 1 to 6°C for 21 days. 24-hour RBC Recovery is a measure of the % of RBCs that are still functioning 24 hours after they have been reinfused back into the donor following storage over 21 days.
36 secondary outcomes
Red Blood Cell (RBC) Survival by Product
Time frame: 28 days
Area Under the Curve (AUC) of Red Blood Cell (RBC) Survival
Time frame: 28 days
Spearman's Correlation Coefficients: 24-Hour Red Blood Cell (RBC) Recovery (%) With Hemolysis (%)
Time frame: 24 hours
Spearman's Correlation Coefficients: 24-Hour RBC Recovery (%) With Adenosine Triphosphate (ATP) (µmol/g Hgb)
Time frame: 24 hours
Spearman's Correlation Coefficients: 24-Hour RBC Recovery (%) pCO2 (mmHg at 37° C)
Time frame: 24 hours
Spearman's Correlation Coefficients: Linear T50 (Days) With Hemolysis (%)
Time frame: 28 days
Spearman's Correlation Coefficients: Linear T50 (Days) With Adenosine Triphosphate (ATP) (µmol/g Hgb)
Time frame: 28 days
Spearman's Correlation Coefficients: Linear T50 (Days) With pCO2 (mmHg at 37° C)
Time frame: 28 days
Neoantigenicity - Day 21 Direct Antigen Test (DAT)
Time frame: Day 21
Neoantigenicity - Day 21 Indirect Antigen Test (IAT)
Time frame: Day 21 of Treatment Periods 1 and 2
Neoantigenicity - Day 42 Direct Antigen Test (DAT)
Time frame: Day 42 of Treatment Periods 1 and 2
Neoantigenicity - Day 42 Indirect Antigen Test (IAT)
Time frame: Day 42 of Treatment Periods 1 and 2
In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Hematocrit (%)
Time frame: Day 0
In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Hematocrit (%)
Time frame: Day 21
In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - ATP
Time frame: Day 0
In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - ATP
Time frame: Day 21
In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - White Blood Cell (WBC) Count
Time frame: Day 0
In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - White Blood Cell (WBC) Count
Time frame: Day 21
In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Total Hemoglobin
Time frame: Day 0
In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Total Hemoglobin
Time frame: Day 21
In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - pH (at 37° C)
Time frame: Day 0
In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - pH (at 37° C)
Time frame: Day 21
In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - pCO2 (mmHg at 37° C)
Time frame: Day 0
In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - pCO2 (mmHg at 37° C)
Time frame: Day 21
In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Potassium
Time frame: Day 0
In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Potassium
Time frame: Day 21
In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Glucose
Time frame: Day 0
In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Glucose
Time frame: Day 21
In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Lactate
Time frame: Day 0
In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Lactate
Time frame: Day 21
In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Supernatant Hgb
Time frame: Day 0
In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Supernatant Hgb
Time frame: Day 21
In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - 2,3-diphosphoglycerate (DPG)
Time frame: Day 0
In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - 2,3-diphosphoglycerate (DPG)
Time frame: Day 21
In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Hemolysis (%)
Time frame: Day 0
In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Hemolysis (%)
Time frame: Day 21
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
Raymond P Goodrich, PhD study director
TerumoBCT Biotechnologies
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 Mirasol System for Whole Blood in people with Focus of Study: Radiolabel Recovery and Survival of RBCs, run by Terumo BCTbio 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 14 inclusion and 6 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 18 Aug 2015. 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 27 Jul 2015). 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) 24-Hour Recovery (time frame: 24 hours). 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 18 Aug 2015.