Trial Outcomes & Findings for Feasibility Study of Mirasol-Treated Whole Blood Red Cell Recovery and Survival (NCT NCT00742001)
NCT ID: NCT00742001
Last Updated: 2019-08-28
Results Overview
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.
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
12 participants
Primary outcome timeframe
24-hour post autologous infusion of RBCs
Results posted on
2019-08-28
Participant Flow
Participant milestones
| Measure |
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
|
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
|
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
|
|---|---|---|---|
|
Overall Study
STARTED
|
4
|
4
|
4
|
|
Overall Study
COMPLETED
|
4
|
4
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
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
|
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
|
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
|
|---|---|---|---|
|
Overall Study
Withdrawn; health exclusion (flu)
|
0
|
0
|
1
|
Baseline Characteristics
Feasibility Study of Mirasol-Treated Whole Blood Red Cell Recovery and Survival
Baseline characteristics by cohort
| Measure |
Mirasol Illumination Dose #1 (A1)
n=4 Participants
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
|
Mirasol Illumination Dose #2 (A2)
n=4 Participants
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
|
Mirasol Illumination Dose #3 (A3)
n=4 Participants
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
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Age, Continuous
|
46 years
STANDARD_DEVIATION 7 • n=5 Participants
|
42 years
STANDARD_DEVIATION 18 • n=7 Participants
|
51 years
STANDARD_DEVIATION 13 • n=5 Participants
|
46 years
STANDARD_DEVIATION 13 • n=4 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=5 Participants
|
4 participants
n=7 Participants
|
4 participants
n=5 Participants
|
12 participants
n=4 Participants
|
|
Height (inches)
|
69 inches
STANDARD_DEVIATION 4 • n=5 Participants
|
70 inches
STANDARD_DEVIATION 3 • n=7 Participants
|
68 inches
STANDARD_DEVIATION 3 • n=5 Participants
|
69 inches
STANDARD_DEVIATION 3 • n=4 Participants
|
|
Weight (lbs)
|
219 lbs
STANDARD_DEVIATION 26 • n=5 Participants
|
180 lbs
STANDARD_DEVIATION 17 • n=7 Participants
|
253 lbs
STANDARD_DEVIATION 62 • n=5 Participants
|
217 lbs
STANDARD_DEVIATION 48 • n=4 Participants
|
|
Pulse (bpm)
|
68 bpm
STANDARD_DEVIATION 5 • n=5 Participants
|
68 bpm
STANDARD_DEVIATION 3 • n=7 Participants
|
72 bpm
STANDARD_DEVIATION 11 • n=5 Participants
|
69 bpm
STANDARD_DEVIATION 7 • n=4 Participants
|
|
Systolic Blood Pressure (mmHg)
|
123 mmHg
STANDARD_DEVIATION 11 • n=5 Participants
|
112 mmHg
STANDARD_DEVIATION 11 • n=7 Participants
|
122 mmHg
STANDARD_DEVIATION 16 • n=5 Participants
|
119 mmHg
STANDARD_DEVIATION 13 • n=4 Participants
|
|
Diastolic Blood Pressure (mmHg)
|
76 mmHg
STANDARD_DEVIATION 5 • n=5 Participants
|
69 mmHg
STANDARD_DEVIATION 7 • n=7 Participants
|
76 mmHg
STANDARD_DEVIATION 13 • n=5 Participants
|
74 mmHg
STANDARD_DEVIATION 9 • n=4 Participants
|
|
Oral Temperature degrees Fahrenheit (F)
|
98 degrees Fahrenheit (F)
STANDARD_DEVIATION 0.6 • n=5 Participants
|
97 degrees Fahrenheit (F)
STANDARD_DEVIATION 0.3 • n=7 Participants
|
97 degrees Fahrenheit (F)
STANDARD_DEVIATION 0.4 • n=5 Participants
|
97 degrees Fahrenheit (F)
STANDARD_DEVIATION 0.5 • n=4 Participants
|
PRIMARY outcome
Timeframe: 24-hour post autologous infusion of RBCsThe 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.
Outcome measures
| Measure |
Mirasol Illumination Dose #1 (A1)
n=4 Participants
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
|
Mirasol Illumination Dose #2 (A2)
n=4 Participants
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
|
Mirasol Illumination Dose #3 (A3)
n=3 Participants
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
|
|---|---|---|---|
|
Red Blood Cell (RBC) Recovery
|
77.8 percentage of recovered RBCs
Standard Deviation 3.4
|
70.5 percentage of recovered RBCs
Standard Deviation 7.5
|
68.1 percentage of recovered RBCs
Standard Deviation 6.3
|
SECONDARY outcome
Timeframe: 28-days post autologous infusion of RBCsThe 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.
Outcome measures
| Measure |
Mirasol Illumination Dose #1 (A1)
n=4 Participants
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
|
Mirasol Illumination Dose #2 (A2)
n=4 Participants
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
|
Mirasol Illumination Dose #3 (A3)
n=3 Participants
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
|
|---|---|---|---|
|
Predicted Total Lifespan of Red Blood Cells (RBCs), Based on 28-day RBC Survival
|
75.9 days
Standard Deviation 17.8
|
66.9 days
Standard Deviation 31.0
|
55.9 days
Standard Deviation 20.6
|
SECONDARY outcome
Timeframe: 28-days post autologous infusion of RBCsOutcome measures
| Measure |
Mirasol Illumination Dose #1 (A1)
n=4 Participants
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
|
Mirasol Illumination Dose #2 (A2)
n=4 Participants
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
|
Mirasol Illumination Dose #3 (A3)
n=3 Participants
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
|
|---|---|---|---|
|
Count of Participants With Serious Adverse Events (SAE)
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Mirasol Illumination Dose #1 (A1)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Mirasol Illumination Dose #2 (A2)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Mirasol Illumination Dose #3 (A3)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Mirasol Illumination Dose #1 (A1)
n=4 participants at risk
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
|
Mirasol Illumination Dose #2 (A2)
n=4 participants at risk
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
|
Mirasol Illumination Dose #3 (A3)
n=4 participants at risk
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
|
|---|---|---|---|
|
Gastrointestinal disorders
Slight heartburn
|
0.00%
0/4 • From the time of autologous RBC re-infusion until study completion (28 days)
|
25.0%
1/4 • Number of events 1 • From the time of autologous RBC re-infusion until study completion (28 days)
|
0.00%
0/4 • From the time of autologous RBC re-infusion until study completion (28 days)
|
|
Respiratory, thoracic and mediastinal disorders
Head stuffiness and congestion (allergy related)
|
25.0%
1/4 • Number of events 1 • From the time of autologous RBC re-infusion until study completion (28 days)
|
0.00%
0/4 • From the time of autologous RBC re-infusion until study completion (28 days)
|
0.00%
0/4 • From the time of autologous RBC re-infusion until study completion (28 days)
|
|
Respiratory, thoracic and mediastinal disorders
Cold, sore throat, sinusitis
|
25.0%
1/4 • Number of events 1 • From the time of autologous RBC re-infusion until study completion (28 days)
|
0.00%
0/4 • From the time of autologous RBC re-infusion until study completion (28 days)
|
0.00%
0/4 • From the time of autologous RBC re-infusion until study completion (28 days)
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory infection
|
0.00%
0/4 • From the time of autologous RBC re-infusion until study completion (28 days)
|
25.0%
1/4 • Number of events 1 • From the time of autologous RBC re-infusion until study completion (28 days)
|
0.00%
0/4 • From the time of autologous RBC re-infusion until study completion (28 days)
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/4 • From the time of autologous RBC re-infusion until study completion (28 days)
|
0.00%
0/4 • From the time of autologous RBC re-infusion until study completion (28 days)
|
25.0%
1/4 • Number of events 1 • From the time of autologous RBC re-infusion until study completion (28 days)
|
|
Respiratory, thoracic and mediastinal disorders
Sinus infection and bronchitis
|
0.00%
0/4 • From the time of autologous RBC re-infusion until study completion (28 days)
|
0.00%
0/4 • From the time of autologous RBC re-infusion until study completion (28 days)
|
25.0%
1/4 • Number of events 1 • From the time of autologous RBC re-infusion until study completion (28 days)
|
|
Respiratory, thoracic and mediastinal disorders
Flu
|
0.00%
0/4 • From the time of autologous RBC re-infusion until study completion (28 days)
|
0.00%
0/4 • From the time of autologous RBC re-infusion until study completion (28 days)
|
25.0%
1/4 • Number of events 1 • From the time of autologous RBC re-infusion until study completion (28 days)
|
Additional Information
Marty Huntington / Sr Mgr Global Clinical Affairs
Terumo BCT
Phone: +1 (303) 231-4849
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee All publication of results and or design of this study are contingent upon approval from the sponsor.
- Publication restrictions are in place
Restriction type: OTHER