IMPROVE: Feasibility Study of Mirasol-Treated Whole Blood Red Cell Recovery and Survival
Sponsor
Terumo BCTbio (Industry)
Overall Status
Terminated
CT.gov ID
NCT00742001
Collaborator
United States Department of Defense (U.S. Fed)
12
1
3
3.2
3.8
Study Details
Study Description
Brief Summary
Feasibility trial to evaluate recovery and survival of red blood cells (RBCs) from Mirasol-treated whole blood
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
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.
Study Design
Study Type:
Interventional
Actual Enrollment
:
12 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Other
Official Title:
IMPROVE: Inactivation of Whole Blood With Mirasol (R): Performance in Red Blood Cells, Platelets and Plasma Investigation
Actual Study Start Date
:
Sep 10, 2008
Actual Primary Completion Date
:
Nov 20, 2008
Actual Study Completion Date
:
Dec 16, 2008
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Mirasol Illumination Dose #1 Whole blood units treated with Mirasol at Illumination dose #1 (A1) of 22 Joules per milliliter of red blood cells (J/mL RBCs) |
Biological: 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
Other Names:
|
| Experimental: Mirasol Illumination Dose #2 Whole Blood units treated with Mirasol at Illumination dose #2 (A2) of 33 J/mL RBCs |
Biological: 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
Other Names:
|
| Experimental: Mirasol Illumination Dose #3 Whole Blood units treated with Mirasol at Illumination dose #3 (A3) of 44 J/mL RBCs |
Biological: 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
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Red Blood Cell (RBC) Recovery [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.
Secondary Outcome Measures
- Predicted Total Lifespan of Red Blood Cells (RBCs), Based on 28-day RBC Survival [28-days post autologous infusion of RBCs]
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.
- Count of Participants With Serious Adverse Events (SAE) [28-days post autologous infusion of RBCs]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
-
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
Exclusion Criteria:
-
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Cincinnati, Hoxworth Blood Center | Cincinnati | Ohio | United States | 45267 |
Sponsors and Collaborators
- Terumo BCTbio
- United States Department of Defense
Investigators
- Principal Investigator: Jose Cancelas-Perez, M.D, Ph.D, University of Cincinnati, Hoxworth Blood Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Terumo BCTbio
ClinicalTrials.gov Identifier:
NCT00742001
Other Study ID Numbers:
- CTS-0040
First Posted:
Aug 27, 2008
Last Update Posted:
Aug 28, 2019
Last Verified:
Aug 1, 2019
Keywords provided by Terumo BCTbio
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Mirasol Illumination Dose #1 (A1) | Mirasol Illumination Dose #2 (A2) | Mirasol Illumination Dose #3 (A3) |
|---|---|---|---|
| Arm/Group Description | 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 | 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 | 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 |
| Period Title: Overall Study | |||
| STARTED | 4 | 4 | 4 |
| COMPLETED | 4 | 4 | 3 |
| NOT COMPLETED | 0 | 0 | 1 |
Baseline Characteristics
| Arm/Group Title | Mirasol Illumination Dose #1 (A1) | Mirasol Illumination Dose #2 (A2) | Mirasol Illumination Dose #3 (A3) | Total |
|---|---|---|---|---|
| Arm/Group Description | 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 | 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 | 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 of all reporting groups |
| Overall Participants | 4 | 4 | 4 | 12 |
| Age (Count of Participants) | ||||
| <=18 years |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Between 18 and 65 years |
4
100%
|
3
75%
|
4
100%
|
11
91.7%
|
| >=65 years |
0
0%
|
1
25%
|
0
0%
|
1
8.3%
|
| Age (years) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [years] |
46
(7)
|
42
(18)
|
51
(13)
|
46
(13)
|
| Sex: Female, Male (Count of Participants) | ||||
| Female |
2
50%
|
2
50%
|
1
25%
|
5
41.7%
|
| Male |
2
50%
|
2
50%
|
3
75%
|
7
58.3%
|
| Ethnicity (NIH/OMB) (Count of Participants) | ||||
| Hispanic or Latino |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Not Hispanic or Latino |
4
100%
|
4
100%
|
4
100%
|
12
100%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Region of Enrollment (participants) [Number] | ||||
| United States |
4
100%
|
4
100%
|
4
100%
|
12
100%
|
| Height (inches) (inches) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [inches] |
69
(4)
|
70
(3)
|
68
(3)
|
69
(3)
|
| Weight (lbs) (lbs) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [lbs] |
219
(26)
|
180
(17)
|
253
(62)
|
217
(48)
|
| Pulse (bpm) (bpm) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [bpm] |
68
(5)
|
68
(3)
|
72
(11)
|
69
(7)
|
| Systolic Blood Pressure (mmHg) (mmHg) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [mmHg] |
123
(11)
|
112
(11)
|
122
(16)
|
119
(13)
|
| Diastolic Blood Pressure (mmHg) (mmHg) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [mmHg] |
76
(5)
|
69
(7)
|
76
(13)
|
74
(9)
|
| Oral Temperature degrees Fahrenheit (F) (degrees Fahrenheit (F)) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [degrees Fahrenheit (F)] |
98
(0.6)
|
97
(0.3)
|
97
(0.4)
|
97
(0.5)
|
Outcome Measures
| Title | Red Blood Cell (RBC) Recovery |
|---|---|
| Description | 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. |
| Time Frame | 24-hour post autologous infusion of RBCs |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Mirasol Illumination Dose #1 (A1) | Mirasol Illumination Dose #2 (A2) | Mirasol Illumination Dose #3 (A3) |
|---|---|---|---|
| Arm/Group Description | 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 | 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 | 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 |
| Measure Participants | 4 | 4 | 3 |
| Mean (Standard Deviation) [percentage of recovered RBCs] |
77.8
(3.4)
|
70.5
(7.5)
|
68.1
(6.3)
|
| Title | Predicted Total Lifespan of Red Blood Cells (RBCs), Based on 28-day RBC Survival |
|---|---|
| Description | 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. |
| Time Frame | 28-days post autologous infusion of RBCs |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Mirasol Illumination Dose #1 (A1) | Mirasol Illumination Dose #2 (A2) | Mirasol Illumination Dose #3 (A3) |
|---|---|---|---|
| Arm/Group Description | Whole blood units treated with Mirasol at Illumination dose #1. 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 | Whole Blood units treated with Mirasol at Illumination dose #2. 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 | Whole Blood units treated with Mirasol at Illumination dose #3. 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 |
| Measure Participants | 4 | 4 | 3 |
| Mean (Standard Deviation) [days] |
75.9
(17.8)
|
66.9
(31.0)
|
55.9
(20.6)
|
| Title | Count of Participants With Serious Adverse Events (SAE) |
|---|---|
| Description | |
| Time Frame | 28-days post autologous infusion of RBCs |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Mirasol Illumination Dose #1 (A1) | Mirasol Illumination Dose #2 (A2) | Mirasol Illumination Dose #3 (A3) |
|---|---|---|---|
| Arm/Group Description | Whole blood units treated with Mirasol at Illumination dose #1. 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 | Whole Blood units treated with Mirasol at Illumination dose #2. 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 | Whole Blood units treated with Mirasol at Illumination dose #3. 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 |
| Measure Participants | 4 | 4 | 3 |
| Count of Participants [Participants] |
0
0%
|
0
0%
|
0
0%
|
Adverse Events
| Time Frame | From the time of autologous RBC re-infusion until study completion (28 days) | |||||
|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||
| Arm/Group Title | Mirasol Illumination Dose #1 (A1) | Mirasol Illumination Dose #2 (A2) | Mirasol Illumination Dose #3 (A3) | |||
| Arm/Group Description | 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 | 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 | 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 | |||
All Cause Mortality |
||||||
| Mirasol Illumination Dose #1 (A1) | Mirasol Illumination Dose #2 (A2) | Mirasol Illumination Dose #3 (A3) | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | |||
Serious Adverse Events |
||||||
| Mirasol Illumination Dose #1 (A1) | Mirasol Illumination Dose #2 (A2) | Mirasol Illumination Dose #3 (A3) | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | |||
Other (Not Including Serious) Adverse Events |
||||||
| Mirasol Illumination Dose #1 (A1) | Mirasol Illumination Dose #2 (A2) | Mirasol Illumination Dose #3 (A3) | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1/4 (25%) | 2/4 (50%) | 2/4 (50%) | |||
| Gastrointestinal disorders | ||||||
| Slight heartburn | 0/4 (0%) | 0 | 1/4 (25%) | 1 | 0/4 (0%) | 0 |
| Dyspepsia | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/4 (25%) | 1 |
| Respiratory, thoracic and mediastinal disorders | ||||||
| Head stuffiness and congestion (allergy related) | 1/4 (25%) | 1 | 0/4 (0%) | 0 | 0/4 (0%) | 0 |
| Cold, sore throat, sinusitis | 1/4 (25%) | 1 | 0/4 (0%) | 0 | 0/4 (0%) | 0 |
| Upper respiratory infection | 0/4 (0%) | 0 | 1/4 (25%) | 1 | 0/4 (0%) | 0 |
| Sinus infection and bronchitis | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/4 (25%) | 1 |
| Flu | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/4 (25%) | 1 |
Limitations/Caveats
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.
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
All publication of results and or design of this study are contingent upon approval from the sponsor.
Results Point of Contact
| Name/Title | Marty Huntington / Sr Mgr Global Clinical Affairs |
|---|---|
| Organization | Terumo BCT |
| Phone | +1 (303) 231-4849 |
| Marty.Huntington@terumobct.com |
Responsible Party:
Terumo BCTbio
ClinicalTrials.gov Identifier:
NCT00742001
Other Study ID Numbers:
- CTS-0040
First Posted:
Aug 27, 2008
Last Update Posted:
Aug 28, 2019
Last Verified:
Aug 1, 2019