Phase 1
N=29
Inactivation of Whole Blood With Mirasol
Focus of Study: Radiolabel Recovery and Survival of RBCs
Bottom Line
View on ClinicalTrials.gov: NCT01907906 ↗Enrolled (actual)
29
Serious AEs
0.0%
Results posted
Jul 2015
Primary outcome: Primary: Red Blood Cell (RBC) 24-Hour Recovery — 82.51; 91.70 % 24-hour RBC Recovery
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Mirasol System for Whole Blood (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Terumo BCTbio
- Primary completion
- May 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Red Blood Cell (RBC) 24-Hour Recovery |
82.51; 91.70 | — |
| SECONDARY Red Blood Cell (RBC) Survival by Product |
60.49; 81.57; 22.58; 35.83; 46.71; 67.81 | — |
| SECONDARY Area Under the Curve (AUC) of Red Blood Cell (RBC) Survival |
1715.2; 2055.2 | — |
| SECONDARY Spearman's Correlation Coefficients: 24-Hour Red Blood Cell (RBC) Recovery (%) With Hemolysis (%) |
-0.1779; 0.4286 | — |
| SECONDARY Spearman's Correlation Coefficients: 24-Hour RBC Recovery (%) With Adenosine Triphosphate (ATP) (µmol/g Hgb) |
0.6107; 0.4116 | — |
| SECONDARY Spearman's Correlation Coefficients: 24-Hour RBC Recovery (%) pCO2 (mmHg at 37° C) |
0.0383; 0.0475 | — |
| SECONDARY Spearman's Correlation Coefficients: Linear T50 (Days) With Hemolysis (%) |
-0.0592; 0.0564 | — |
| SECONDARY Spearman's Correlation Coefficients: Linear T50 (Days) With Adenosine Triphosphate (ATP) (µmol/g Hgb) |
0.2487; 0.0261 | — |
| SECONDARY Spearman's Correlation Coefficients: Linear T50 (Days) With pCO2 (mmHg at 37° C) |
-0.0691; -0.1065 | — |
| SECONDARY Neoantigenicity - Day 21 Direct Antigen Test (DAT) |
0; 0 | — |
| SECONDARY Neoantigenicity - Day 21 Indirect Antigen Test (IAT) |
0; 0 | — |
| SECONDARY Neoantigenicity - Day 42 Direct Antigen Test (DAT) |
0; 0 | — |
| SECONDARY Neoantigenicity - Day 42 Indirect Antigen Test (IAT) |
0; 0 | — |
| SECONDARY In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Hematocrit (%) |
58.3; 60.5 | — |
| SECONDARY In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Hematocrit (%) |
58.3; 60.5 | — |
| SECONDARY In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - ATP |
4.416; 5.403 | — |
| SECONDARY In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - ATP |
4.416; 5.403 | — |
| SECONDARY In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - White Blood Cell (WBC) Count |
0.004; 0.021 | — |
| SECONDARY In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - White Blood Cell (WBC) Count |
0.004; 0.021 | — |
| SECONDARY In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Total Hemoglobin |
19.26; 19.90 | — |
| SECONDARY In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Total Hemoglobin |
19.26; 19.90 | — |
| SECONDARY In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - pH (at 37° C) |
6.5537; 6.5662 | — |
| SECONDARY In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - pH (at 37° C) |
6.5537; 6.5662 | — |
| SECONDARY In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - pCO2 (mmHg at 37° C) |
93.09; 98.43 | — |
| SECONDARY In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - pCO2 (mmHg at 37° C) |
93.09; 98.43 | — |
| SECONDARY In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Potassium |
65.50; 36.73 | — |
| SECONDARY In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Potassium |
65.50; 36.73 | — |
| SECONDARY In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Glucose |
408.5; 398.6 | — |
| SECONDARY In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Glucose |
408.5; 398.6 | — |
| SECONDARY In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Lactate |
17.54; 20.34 | — |
| SECONDARY In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Lactate |
17.54; 20.34 | — |
| SECONDARY In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Supernatant Hgb |
99.6; 76.7 | — |
| SECONDARY In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Supernatant Hgb |
99.6; 76.7 | — |
| SECONDARY In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - 2,3-diphosphoglycerate (DPG) |
0.248; 0.333 | — |
| SECONDARY In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - 2,3-diphosphoglycerate (DPG) |
0.248; 0.333 | — |
| SECONDARY In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Hemolysis (%) |
0.215; 0.150 | — |
| SECONDARY In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Hemolysis (%) |
0.215; 0.150 | — |
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
Eligibility Criteria
Inclusion Criteria
- 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
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT01907906). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.