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An endpoint difference between 3 energies was not observed at interim analysis
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| Name | Class |
|---|---|
| United States Department of Defense | FED |
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Feasibility trial to evaluate recovery and survival of red blood cells (RBCs) from Mirasol-treated whole blood
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
|
| Mirasol Illumination Dose #2 | Experimental | Whole Blood units treated with Mirasol at Illumination dose #2 (A2) of 33 J/mL RBCs |
|
| Mirasol Illumination Dose #3 | Experimental | Whole Blood units treated with Mirasol at Illumination dose #3 (A3) of 44 J/mL RBCs |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mirasol System for Whole Blood. | Biological | Treatment of whole blood with the Mirasol system at 3 experimental illumination energies for testing of autologous RBC recovery and survival in healthy subjects |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 24-hour post autologous infusion of RBCs |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jose Cancelas-Perez, M.D, Ph.D | University of Cincinnati, Hoxworth Blood Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Cincinnati, Hoxworth Blood Center | Cincinnati | Ohio | 45267 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Mirasol Illumination Dose #1 (A1) | Whole blood units treated with Mirasol at Illumination dose #1: 22 Joules per milliliter of red blood cells (J/mL RBC) Mirasol System for Whole Blood.: Treatment of whole blood with the Mirasol system at 3 experimental illumination energies for testing of autologous RBC recovery and survival in healthy subjects |
| FG001 | Mirasol Illumination Dose #2 (A2) | Whole Blood units treated with Mirasol at Illumination dose #2: 33 J/mL RBC Mirasol System for Whole Blood.: Treatment of whole blood with the Mirasol system at 3 experimental illumination energies for testing of autologous RBC recovery and survival in healthy subjects |
| FG002 | Mirasol Illumination Dose #3 (A3) | Whole Blood units treated with Mirasol at Illumination dose #3: 44 J/mL RBC Mirasol System for Whole Blood.: Treatment of whole blood with the Mirasol system at 3 experimental illumination energies for testing of autologous RBC recovery and survival in healthy subjects |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Mirasol Illumination Dose #1 (A1) | Whole blood units treated with Mirasol at Illumination dose #1: 22 J/mL RBC Mirasol System for Whole Blood.: Treatment of whole blood with the Mirasol system at 3 experimental illumination energies for testing of autologous RBC recovery and survival in healthy subjects |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | percentage of recovered RBCs | 24-hour post autologous infusion of RBCs |
|
From the time of autologous RBC re-infusion until study completion (28 days)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Mirasol Illumination Dose #1 (A1) | Whole blood units treated with Mirasol at Illumination dose #1: 22 J/mL RBC Mirasol System for Whole Blood.: Treatment of whole blood with the Mirasol system at 3 experimental illumination energies for testing of autologous RBC recovery and survival in healthy subjects |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Slight heartburn | Gastrointestinal disorders |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Marty Huntington / Sr Mgr Global Clinical Affairs | Terumo BCT | +1 (303) 231-4849 | Marty.Huntington@terumobct.com |
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|
| 28-days post autologous infusion of RBCs |
| Count of Participants With Serious Adverse Events (SAE) | 28-days post autologous infusion of RBCs |
| Mirasol Illumination Dose #2 (A2) |
Whole Blood units treated with Mirasol at Illumination dose #2: 33 J/mL RBC Mirasol System for Whole Blood.: Treatment of whole blood with the Mirasol system at 3 experimental illumination energies for testing of autologous RBC recovery and survival in healthy subjects |
| BG002 | Mirasol Illumination Dose #3 (A3) | Whole Blood units treated with Mirasol at Illumination dose #3: 44 J/mL RBC Mirasol System for Whole Blood.: Treatment of whole blood with the Mirasol system at 3 experimental illumination energies for testing of autologous RBC recovery and survival in healthy subjects |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Height (inches) | Mean | Standard Deviation | inches |
|
| Weight (lbs) | Mean | Standard Deviation | lbs |
|
| Pulse (bpm) | Mean | Standard Deviation | bpm |
|
| Systolic Blood Pressure (mmHg) | Mean | Standard Deviation | mmHg |
|
| Diastolic Blood Pressure (mmHg) | Mean | Standard Deviation | mmHg |
|
| Oral Temperature degrees Fahrenheit (F) | Mean | Standard Deviation | degrees Fahrenheit (F) |
|
Whole Blood units treated with Mirasol at Illumination dose #2: 33 J/mL RBC Mirasol System for Whole Blood.: Treatment of whole blood with the Mirasol system at 3 experimental illumination energies for testing of autologous RBC recovery and survival in healthy subjects |
| OG002 | Mirasol Illumination Dose #3 (A3) | Whole Blood units treated with Mirasol at Illumination dose #3: 44 J/mL RBC Mirasol System for Whole Blood.: Treatment of whole blood with the Mirasol system at 3 experimental illumination energies for testing of autologous RBC recovery and survival in healthy subjects |
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | days | 28-days post autologous infusion of RBCs |
|
|
|
| Secondary | Count of Participants With Serious Adverse Events (SAE) | Posted | Count of Participants | Participants | 28-days post autologous infusion of RBCs |
|
|
|
| 0 |
| 4 |
| 0 |
| 4 |
| 1 |
| 4 |
| EG001 | Mirasol Illumination Dose #2 (A2) | Whole Blood units treated with Mirasol at Illumination dose #2: 33 J/mL RBC Mirasol System for Whole Blood.: Treatment of whole blood with the Mirasol system at 3 experimental illumination energies for testing of autologous RBC recovery and survival in healthy subjects | 0 | 4 | 0 | 4 | 2 | 4 |
| EG002 | Mirasol Illumination Dose #3 (A3) | Whole Blood units treated with Mirasol at Illumination dose #3: 44 J/mL RBC Mirasol System for Whole Blood.: Treatment of whole blood with the Mirasol system at 3 experimental illumination energies for testing of autologous RBC recovery and survival in healthy subjects | 0 | 4 | 0 | 4 | 2 | 4 |
| Head stuffiness and congestion (allergy related) | Respiratory, thoracic and mediastinal disorders |
|
| Cold, sore throat, sinusitis | Respiratory, thoracic and mediastinal disorders |
|
| Upper respiratory infection | Respiratory, thoracic and mediastinal disorders |
|
| Dyspepsia | Gastrointestinal disorders |
|
| Sinus infection and bronchitis | Respiratory, thoracic and mediastinal disorders |
|
| Flu | Respiratory, thoracic and mediastinal disorders |
|
All publication of results and or design of this study are contingent upon approval from the sponsor.