Clinical trial NCT01907906: Inactivation of Whole Blood With Mirasol
Official title: Inactivation of Whole Blood With Mirasol : Performance in Red Blood Cells in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Focus of Study: Radiolabel Recovery and Survival of RBCs
Keywords: Pathogen reduction technology
Lead sponsor: Terumo BCTbio
Sponsor class: INDUSTRY
Collaborators: name: U.S. Army Medical Research and Development Command
First posted: 2013-07-25
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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

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

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

Primary outcomes:
measure: Red Blood Cell (RBC) 24-Hour Recovery
timeFrame: 24 hours
Secondary outcomes:
measure: Red Blood Cell (RBC) Survival by Product
timeFrame: 28 days
measure: Area Under the Curve (AUC) of Red Blood Cell (RBC) Survival
timeFrame: 28 days
measure: Spearman's Correlation Coefficients: 24-Hour Red Blood Cell (RBC) Recovery (%) With Hemolysis (%)
timeFrame: 24 hours
measure: Spearman's Correlation Coefficients: 24-Hour RBC Recovery (%) With Adenosine Triphosphate (ATP) (µmol/g Hgb)
timeFrame: 24 hours
measure: Spearman's Correlation Coefficients: 24-Hour RBC Recovery (%) pCO2 (mmHg at 37° C)
timeFrame: 24 hours
measure: Spearman's Correlation Coefficients: Linear T50 (Days) With Hemolysis (%)
timeFrame: 28 days
measure: Spearman's Correlation Coefficients: Linear T50 (Days) With Adenosine Triphosphate (ATP) (µmol/g Hgb)
timeFrame: 28 days
measure: Spearman's Correlation Coefficients: Linear T50 (Days) With pCO2 (mmHg at 37° C)
timeFrame: 28 days
measure: Neoantigenicity - Day 21 Direct Antigen Test (DAT)
timeFrame: Day 21
measure: Neoantigenicity - Day 21 Indirect Antigen Test (IAT)
timeFrame: Day 21 of Treatment Periods 1 and 2
measure: Neoantigenicity - Day 42 Direct Antigen Test (DAT)
timeFrame: Day 42 of Treatment Periods 1 and 2
measure: Neoantigenicity - Day 42 Indirect Antigen Test (IAT)
timeFrame: Day 42 of Treatment Periods 1 and 2
measure: In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Hematocrit (%)
timeFrame: Day 0
measure: In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Hematocrit (%)
timeFrame: Day 21
measure: In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - ATP
timeFrame: Day 0
measure: In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - ATP
timeFrame: Day 21
measure: In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - White Blood Cell (WBC) Count
timeFrame: Day 0
measure: In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - White Blood Cell (WBC) Count
timeFrame: Day 21
measure: In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Total Hemoglobin
timeFrame: Day 0
measure: In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Total Hemoglobin
timeFrame: Day 21
measure: In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - pH (at 37° C)
timeFrame: Day 0
measure: In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - pH (at 37° C)
timeFrame: Day 21
measure: In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - pCO2 (mmHg at 37° C)
timeFrame: Day 0
measure: In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - pCO2 (mmHg at 37° C)
timeFrame: Day 21
measure: In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Potassium
timeFrame: Day 0
measure: In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Potassium
timeFrame: Day 21
measure: In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Glucose
timeFrame: Day 0
measure: In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Glucose
timeFrame: Day 21
measure: In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Lactate
timeFrame: Day 0
measure: In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Lactate
timeFrame: Day 21
measure: In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Supernatant Hgb
timeFrame: Day 0
measure: In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Supernatant Hgb
timeFrame: Day 21
measure: In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - 2,3-diphosphoglycerate (DPG)
timeFrame: Day 0
measure: In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - 2,3-diphosphoglycerate (DPG)
timeFrame: Day 21
measure: In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Hemolysis (%)
timeFrame: Day 0
measure: In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Hemolysis (%)
timeFrame: Day 21
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Hoxworth Blood Center
state: Ohio
city: Seattle
country: United States
facility: Puget Sound Blood Center
state: Washington
Study officials:
affiliation: TerumoBCT Biotechnologies
name: Raymond P Goodrich, PhD
role: STUDY_DIRECTOR
References: