Inactivation of Whole Blood With Mirasol

Phase 1CompletedNCT01907906

Terumo BCTbio29 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Focus of Study: Radiolabel Recovery and Survival of RBCs

Interventions

Mirasol System for Whole BloodDEVICE

LR-pRBC units derived from WB will be treated with the Mirasol System. Treatment with the Mirasol System requires riboflavin to be mixed into the whole blood unit, which is then exposed to ultra violet (UV) light for a period of time; approximately an hour.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (2)

Hoxworth Blood Center

Cincinnati, Ohio, United States

Puget Sound Blood Center

Seattle, Washington, United States

Outcomes

Primary Outcomes

Red Blood Cell (RBC) 24-Hour Recovery

To evaluate, as per FDA criteria, the 24-hour post transfusion RBC recovery in healthy adult subjects of leuko-reduced packed red blood cells (LR-pRBC) that have been derived from Mirasol-treated fresh WB units and stored at 1 to 6°C for 21 days. 24-hour RBC Recovery is a measure of the % of RBCs that are still functioning 24 hours after they have been reinfused back into the donor following storage over 21 days.

Time frame: 24 hours

Secondary Outcomes

Red Blood Cell (RBC) Survival by Product

Assessment of linear \& exponential RBC survival and half-life (T50) over 28 days for RBCs derived from Mirasol-treated WB versus RBCs derived from untreated WB.

Time frame: 28 days

Area Under the Curve (AUC) of Red Blood Cell (RBC) Survival

Assessment of AUC of RBC survival over 28 days for RBCs derived from Mirasol-treated Whole Blood (WB) versus RBCs derived from untreated WB.

Time frame: 28 days

Spearman's Correlation Coefficients: 24-Hour Red Blood Cell (RBC) Recovery (%) With Hemolysis (%)

Spearman's Correlation Coefficients comparing 24-Hour RBC Recovery (%) with Hemolysis (%) in packed Red Blood Cells (pRBCs) derived from Mirasol-treated whole blood (WB) versus pRBCs derived from untreated WB

Time frame: 24 hours

Spearman's Correlation Coefficients: 24-Hour RBC Recovery (%) With Adenosine Triphosphate (ATP) (µmol/g Hgb)

Spearman's Correlation Coefficients comparing 24-Hour RBC Recovery (%) with ATP (µmol/g Hgb) in packed Red Blood Cells (pRBCs) derived from Mirasol-treated whole blood (WB) versus pRBCs derived from untreated WB

Time frame: 24 hours

Spearman's Correlation Coefficients: 24-Hour RBC Recovery (%) pCO2 (mmHg at 37° C)

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Spearman's Correlation Coefficients comparing 24-Hour RBC Recovery (%) with pCO2 (mmHg at 37° C) in packed Red Blood Cells (pRBCs) derived from Mirasol-treated whole blood (WB) versus pRBCs derived from untreated WB

Time frame: 24 hours

Spearman's Correlation Coefficients: Linear T50 (Days) With Hemolysis (%)

Spearman's Correlation Coefficients comparing Linear T50 (Days) with each of Hemolysis (%) in packed Red Blood Cells (pRBCs) derived from Mirasol-treated whole blood (WB) versus pRBCs derived from untreated WB

Time frame: 28 days

Spearman's Correlation Coefficients: Linear T50 (Days) With Adenosine Triphosphate (ATP) (µmol/g Hgb)

Spearman's Correlation Coefficients comparing Linear T50 (Days) with ATP (µmol/g Hgb) in packed Red Blood Cells (pRBCs) derived from Mirasol-treated whole blood (WB) versus pRBCs derived from untreated WB

Time frame: 28 days

Spearman's Correlation Coefficients: Linear T50 (Days) With pCO2 (mmHg at 37° C)

Spearman's Correlation Coefficients comparing Linear T50 (Days) with pCO2 (mmHg at 37° C) in packed Red Blood Cells (pRBCs) derived from Mirasol-treated whole blood (WB) versus pRBCs derived from untreated WB

Time frame: 28 days

Neoantigenicity - Day 21 Direct Antigen Test (DAT)

DAT testing of Red Blood Cells (RBCs) via Anti-immunoglobulin G (Anti-IgG) and Anti Complement Component 3 (Anti-C3) as derived from Mirasol-treated whole blood (WB) versus untreated WB conducted on Day 21 of both Treatment Periods 1 and 2. Number of positive results (indicating a new antigen formation) were recorded.

Time frame: Day 21

Neoantigenicity - Day 21 Indirect Antigen Test (IAT)

Day 21 IAT testing of RBCs via LISS-15, Anti-IgG and C3 as derived from Mirasol-treated WB versus untreated WB. Number of positive results (indicating antibody formation to a new antigen) were recorded.

Time frame: Day 21 of Treatment Periods 1 and 2

Neoantigenicity - Day 42 Direct Antigen Test (DAT)

DAT testing of RBCs via Anti-IgG and Anti-C3 as derived from Mirasol-treated WB versus untreated WB. Number of positive results (indicating a new antigen formation) were recorded.

Time frame: Day 42 of Treatment Periods 1 and 2

Neoantigenicity - Day 42 Indirect Antigen Test (IAT)

IAT testing of RBCs via low ionic strength solution (LISS-15), Anti-IgG and C3 as derived from Mirasol-treated WB versus untreated WB. Number of positive results (indicating antibody formation to a new antigen) were recorded.

Time frame: Day 42 of Treatment Periods 1 and 2

In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Hematocrit (%)

Time frame: Day 0

In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Hematocrit (%)

Time frame: Day 21

In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - ATP

Time frame: Day 0

In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - ATP

Time frame: Day 21

In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - White Blood Cell (WBC) Count

Time frame: Day 0

In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - White Blood Cell (WBC) Count

Time frame: Day 21

In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Total Hemoglobin

Time frame: Day 0

In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Total Hemoglobin

Time frame: Day 21

In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - pH (at 37° C)

Time frame: Day 0

In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - pH (at 37° C)

Time frame: Day 21

In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - pCO2 (mmHg at 37° C)

Time frame: Day 0

In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - pCO2 (mmHg at 37° C)

Time frame: Day 21

In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Potassium

Time frame: Day 0

In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Potassium

Time frame: Day 21

In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Glucose

Time frame: Day 0

In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Glucose

Time frame: Day 21

In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Lactate

Time frame: Day 0

In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Lactate

Time frame: Day 21

In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Supernatant Hgb

Time frame: Day 0

In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Supernatant Hgb

Time frame: Day 21

In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - 2,3-diphosphoglycerate (DPG)

Time frame: Day 0

In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - 2,3-diphosphoglycerate (DPG)

Time frame: Day 21

In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Hemolysis (%)

Time frame: Day 0

In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Hemolysis (%)

Time frame: Day 21