In vivo viability of stored red blood cells derived from riboflavin plus ultraviolet light-treated whole blood
BACKGROUND: A novel system using ultraviolet (UV) light and riboflavin (Mirasol System, CaridianBCT Biotechnologies) to fragment nucleic acids has been developed to treat whole blood (WB), aiming at the reduction of potential pathogen load and white blood cell inactivation. We evaluated stored red b...
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| Published in | Transfusion (Philadelphia, Pa.) Vol. 51; no. 7; pp. 1460 - 1468 |
|---|---|
| Main Authors | , , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
Malden, USA
Blackwell Publishing Inc
01.07.2011
Wiley |
| Subjects | |
| Online Access | Get full text |
| ISSN | 0041-1132 1537-2995 1537-2995 |
| DOI | 10.1111/j.1537-2995.2010.03027.x |
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| Abstract | BACKGROUND: A novel system using ultraviolet (UV) light and riboflavin (Mirasol System, CaridianBCT Biotechnologies) to fragment nucleic acids has been developed to treat whole blood (WB), aiming at the reduction of potential pathogen load and white blood cell inactivation. We evaluated stored red blood cell (RBC) metabolic status and viability, in vitro and in vivo, of riboflavin/UV light–treated WB (IMPROVE study).
STUDY DESIGN AND METHODS: The study compared recovery and survival of RBCs obtained from nonleukoreduced WB treated using three different UV light energies (22, 33, or 44 J/mLRBC). After treatment, WB from 12 subjects was separated into components and tested at the beginning and end of component storage. After 42 days of storage, an aliquot of RBCs was radiolabeled and autologously reinfused into subjects for analysis of 24‐hour recovery and survival of RBCs.
RESULTS: Eleven subjects completed the in vivo study. No device‐related adverse events were observed. By Day 42 of storage, a significant change in the concentrations of sodium and potassium was observed. Five subjects had a 24‐hour RBC recovery of 75% or more with no significant differences among the energy groups. RBC t1/2 was 24 ± 9 days for the combined three groups. Significant correlations between 24‐hour RBC recovery and survival, hemolysis, adenosine triphosphate (ATP), and CO2 levels were observed.
CONCLUSIONS: This study shows that key RBC quality variables, hemolysis, and ATP concentration may be predictive of their 24‐hour recovery and t1/2 survival. These variables will now be used to assess modifications to the system including storage duration, storage temperature, and appropriate energy dose for treatment. |
|---|---|
| AbstractList | BACKGROUND:
A novel system using ultraviolet (UV) light and riboflavin (Mirasol System, CaridianBCT Biotechnologies) to fragment nucleic acids has been developed to treat whole blood (WB), aiming at the reduction of potential pathogen load and white blood cell inactivation. We evaluated stored red blood cell (RBC) metabolic status and viability, in vitro and in vivo, of riboflavin/UV light–treated WB (IMPROVE study).
STUDY DESIGN AND METHODS:
The study compared recovery and survival of RBCs obtained from nonleukoreduced WB treated using three different UV light energies (22, 33, or 44 J/mL
RBC
). After treatment, WB from 12 subjects was separated into components and tested at the beginning and end of component storage. After 42 days of storage, an aliquot of RBCs was radiolabeled and autologously reinfused into subjects for analysis of 24‐hour recovery and survival of RBCs.
RESULTS:
Eleven subjects completed the in vivo study. No device‐related adverse events were observed. By Day 42 of storage, a significant change in the concentrations of sodium and potassium was observed. Five subjects had a 24‐hour RBC recovery of 75% or more with no significant differences among the energy groups. RBC t
1/2
was 24 ± 9 days for the combined three groups. Significant correlations between 24‐hour RBC recovery and survival, hemolysis, adenosine triphosphate (ATP), and CO
2
levels were observed.
CONCLUSIONS:
This study shows that key RBC quality variables, hemolysis, and ATP concentration may be predictive of their 24‐hour recovery and t
1/2
survival. These variables will now be used to assess modifications to the system including storage duration, storage temperature, and appropriate energy dose for treatment. BACKGROUND: A novel system using ultraviolet (UV) light and riboflavin (Mirasol System, CaridianBCT Biotechnologies) to fragment nucleic acids has been developed to treat whole blood (WB), aiming at the reduction of potential pathogen load and white blood cell inactivation. We evaluated stored red blood cell (RBC) metabolic status and viability, in vitro and in vivo, of riboflavin/UV light–treated WB (IMPROVE study). STUDY DESIGN AND METHODS: The study compared recovery and survival of RBCs obtained from nonleukoreduced WB treated using three different UV light energies (22, 33, or 44 J/mLRBC). After treatment, WB from 12 subjects was separated into components and tested at the beginning and end of component storage. After 42 days of storage, an aliquot of RBCs was radiolabeled and autologously reinfused into subjects for analysis of 24‐hour recovery and survival of RBCs. RESULTS: Eleven subjects completed the in vivo study. No device‐related adverse events were observed. By Day 42 of storage, a significant change in the concentrations of sodium and potassium was observed. Five subjects had a 24‐hour RBC recovery of 75% or more with no significant differences among the energy groups. RBC t1/2 was 24 ± 9 days for the combined three groups. Significant correlations between 24‐hour RBC recovery and survival, hemolysis, adenosine triphosphate (ATP), and CO2 levels were observed. CONCLUSIONS: This study shows that key RBC quality variables, hemolysis, and ATP concentration may be predictive of their 24‐hour recovery and t1/2 survival. These variables will now be used to assess modifications to the system including storage duration, storage temperature, and appropriate energy dose for treatment. A novel system using ultraviolet (UV) light and riboflavin (Mirasol System, CaridianBCT Biotechnologies) to fragment nucleic acids has been developed to treat whole blood (WB), aiming at the reduction of potential pathogen load and white blood cell inactivation. We evaluated stored red blood cell (RBC) metabolic status and viability, in vitro and in vivo, of riboflavin/UV light-treated WB (IMPROVE study). The study compared recovery and survival of RBCs obtained from nonleukoreduced WB treated using three different UV light energies (22, 33, or 44 J/mL(RBC)). After treatment, WB from 12 subjects was separated into components and tested at the beginning and end of component storage. After 42 days of storage, an aliquot of RBCs was radiolabeled and autologously reinfused into subjects for analysis of 24-hour recovery and survival of RBCs. Eleven subjects completed the in vivo study. No device-related adverse events were observed. By Day 42 of storage, a significant change in the concentrations of sodium and potassium was observed. Five subjects had a 24-hour RBC recovery of 75% or more with no significant differences among the energy groups. RBC t(1/2) was 24 ± 9 days for the combined three groups. Significant correlations between 24-hour RBC recovery and survival, hemolysis, adenosine triphosphate (ATP), and CO(2) levels were observed. This study shows that key RBC quality variables, hemolysis, and ATP concentration may be predictive of their 24-hour recovery and t(1/2) survival. These variables will now be used to assess modifications to the system including storage duration, storage temperature, and appropriate energy dose for treatment. A novel system using ultraviolet (UV) light and riboflavin (Mirasol System, CaridianBCT Biotechnologies) to fragment nucleic acids has been developed to treat whole blood (WB), aiming at the reduction of potential pathogen load and white blood cell inactivation. We evaluated stored red blood cell (RBC) metabolic status and viability, in vitro and in vivo, of riboflavin/UV light-treated WB (IMPROVE study).BACKGROUNDA novel system using ultraviolet (UV) light and riboflavin (Mirasol System, CaridianBCT Biotechnologies) to fragment nucleic acids has been developed to treat whole blood (WB), aiming at the reduction of potential pathogen load and white blood cell inactivation. We evaluated stored red blood cell (RBC) metabolic status and viability, in vitro and in vivo, of riboflavin/UV light-treated WB (IMPROVE study).The study compared recovery and survival of RBCs obtained from nonleukoreduced WB treated using three different UV light energies (22, 33, or 44 J/mL(RBC)). After treatment, WB from 12 subjects was separated into components and tested at the beginning and end of component storage. After 42 days of storage, an aliquot of RBCs was radiolabeled and autologously reinfused into subjects for analysis of 24-hour recovery and survival of RBCs.STUDY DESIGN AND METHODSThe study compared recovery and survival of RBCs obtained from nonleukoreduced WB treated using three different UV light energies (22, 33, or 44 J/mL(RBC)). After treatment, WB from 12 subjects was separated into components and tested at the beginning and end of component storage. After 42 days of storage, an aliquot of RBCs was radiolabeled and autologously reinfused into subjects for analysis of 24-hour recovery and survival of RBCs.Eleven subjects completed the in vivo study. No device-related adverse events were observed. By Day 42 of storage, a significant change in the concentrations of sodium and potassium was observed. Five subjects had a 24-hour RBC recovery of 75% or more with no significant differences among the energy groups. RBC t(1/2) was 24 ± 9 days for the combined three groups. Significant correlations between 24-hour RBC recovery and survival, hemolysis, adenosine triphosphate (ATP), and CO(2) levels were observed.RESULTSEleven subjects completed the in vivo study. No device-related adverse events were observed. By Day 42 of storage, a significant change in the concentrations of sodium and potassium was observed. Five subjects had a 24-hour RBC recovery of 75% or more with no significant differences among the energy groups. RBC t(1/2) was 24 ± 9 days for the combined three groups. Significant correlations between 24-hour RBC recovery and survival, hemolysis, adenosine triphosphate (ATP), and CO(2) levels were observed.This study shows that key RBC quality variables, hemolysis, and ATP concentration may be predictive of their 24-hour recovery and t(1/2) survival. These variables will now be used to assess modifications to the system including storage duration, storage temperature, and appropriate energy dose for treatment.CONCLUSIONSThis study shows that key RBC quality variables, hemolysis, and ATP concentration may be predictive of their 24-hour recovery and t(1/2) survival. These variables will now be used to assess modifications to the system including storage duration, storage temperature, and appropriate energy dose for treatment. |
| Author | Cancelas, Jose A. Reddy, Heather L. Fletcher, Dana Goodrich, Raymond P. Pratt, P. Gayle Worsham, D. Nicole Dunn, Susan K. Marschner, Susanne Rugg, Neeta |
| Author_xml | – sequence: 1 givenname: Jose A. surname: Cancelas fullname: Cancelas, Jose A. organization: From the Hoxworth Blood Center, Cincinnati, Ohio; and CaridianBCT Biotechnologies, Lakewood, Colorado – sequence: 2 givenname: Neeta surname: Rugg fullname: Rugg, Neeta organization: From the Hoxworth Blood Center, Cincinnati, Ohio; and CaridianBCT Biotechnologies, Lakewood, Colorado – sequence: 3 givenname: Dana surname: Fletcher fullname: Fletcher, Dana organization: From the Hoxworth Blood Center, Cincinnati, Ohio; and CaridianBCT Biotechnologies, Lakewood, Colorado – sequence: 4 givenname: P. Gayle surname: Pratt fullname: Pratt, P. Gayle organization: From the Hoxworth Blood Center, Cincinnati, Ohio; and CaridianBCT Biotechnologies, Lakewood, Colorado – sequence: 5 givenname: D. Nicole surname: Worsham fullname: Worsham, D. Nicole organization: From the Hoxworth Blood Center, Cincinnati, Ohio; and CaridianBCT Biotechnologies, Lakewood, Colorado – sequence: 6 givenname: Susan K. surname: Dunn fullname: Dunn, Susan K. organization: From the Hoxworth Blood Center, Cincinnati, Ohio; and CaridianBCT Biotechnologies, Lakewood, Colorado – sequence: 7 givenname: Susanne surname: Marschner fullname: Marschner, Susanne organization: From the Hoxworth Blood Center, Cincinnati, Ohio; and CaridianBCT Biotechnologies, Lakewood, Colorado – sequence: 8 givenname: Heather L. surname: Reddy fullname: Reddy, Heather L. organization: From the Hoxworth Blood Center, Cincinnati, Ohio; and CaridianBCT Biotechnologies, Lakewood, Colorado – sequence: 9 givenname: Raymond P. surname: Goodrich fullname: Goodrich, Raymond P. organization: From the Hoxworth Blood Center, Cincinnati, Ohio; and CaridianBCT Biotechnologies, Lakewood, Colorado |
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| Keywords | Blood cell Treatment Transfusion Conservation Red blood cell Riboflavin B-Vitamins |
| Language | English |
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Transfusion 1999;39:128-34. 2004; 44 2010; 38 2009; 41 2010 1980; 45 2008; 36 2009; 113 2005; 81 2008; 95 2009; 49 2005; 45 1998; 38 1992; 6 2006; 61 2006; 46 2002; 42 1981; 115 1975; 28 1999; 39 2008; 48 2009; 108 2007; 21 2004; 80 1992; 82 2007; 47 2010; 50 e_1_2_8_27_2 e_1_2_8_28_2 e_1_2_8_29_2 e_1_2_8_23_2 e_1_2_8_24_2 e_1_2_8_25_2 e_1_2_8_26_2 e_1_2_8_9_2 Cancelas JA (e_1_2_8_22_2) 2008; 95 e_1_2_8_4_2 e_1_2_8_3_2 e_1_2_8_6_2 e_1_2_8_5_2 e_1_2_8_8_2 e_1_2_8_7_2 e_1_2_8_20_2 e_1_2_8_21_2 e_1_2_8_16_2 e_1_2_8_17_2 e_1_2_8_18_2 e_1_2_8_19_2 e_1_2_8_12_2 e_1_2_8_13_2 e_1_2_8_14_2 e_1_2_8_15_2 Rock G (e_1_2_8_2_2) 2010 e_1_2_8_31_2 e_1_2_8_30_2 e_1_2_8_10_2 e_1_2_8_11_2 |
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International Committee for Standardization in Haematology publication-title: Br J Haematol – volume: 45 start-page: 1750 year: 2005 end-page: 8 article-title: Platelet glycolytic flux increases stimulated by ultraviolet‐induced stress is not the direct cause of platelet morphology and activation changes: possible implications for the role of glucose in platelet storage publication-title: Transfusion – volume: 46 start-page: 1553 year: 2006 end-page: 60 article-title: Mirasol PRT treatment of donor white blood cells prevents the development of xenogeneic graft‐versus‐host disease in Rag2‐/‐gamma c‐/‐ double knockout mice publication-title: Transfusion – volume: 42 start-page: 146 year: 2002 end-page: 52 article-title: Production of pathogen‐inactivated RBC concentrates using PEN110 chemistry: a Phase I clinical study publication-title: Transfusion – volume: 113 start-page: 3406 year: 2009 end-page: 17 article-title: Transfusion‐related mortality: the ongoing risks of allogeneic blood transfusion and the available strategies for their prevention publication-title: Blood – volume: 82 start-page: 114 year: 1992 end-page: 21 article-title: Improved post‐transfusion quality of density separated AS‐3 red cells after extended storage publication-title: Br J Haematol – volume: 6 start-page: 153 year: 1992 end-page: 69 article-title: Evaluation of posttransfusion recovery and survival of transfused red cells publication-title: Transfus Med Rev – volume: 61 start-page: 181 year: 2006 end-page: 4 article-title: Fresh whole blood transfusion: a controversial military practice publication-title: J Trauma – volume: 41 start-page: 199 year: 2009 end-page: 204 article-title: The influence of riboflavin photochemistry on plasma coagulation factors publication-title: Transfus Apher Sci – volume: 44 start-page: 1 year: 2004 end-page: 4 article-title: Universal leukoreduction and acute transfusion reactions: putting the puzzle together publication-title: Transfusion – volume: 46 start-page: 1778 year: 2006 end-page: 86 article-title: Viability of red cells prepared with S‐303 pathogen inactivation treatment publication-title: Transfusion – volume: 50 start-page: 2461 year: 2010 end-page: 73 article-title: The cost‐effectiveness of pathogen reduction technology as assessed using a multiple risk reduction model publication-title: Transfusion – volume: 36 start-page: S340 year: 2008 end-page: 5 article-title: Warm fresh whole blood transfusion for severe hemorrhage: U.S. military and potential civilian applications publication-title: Crit Care Med – ident: e_1_2_8_20_2 doi: 10.1046/j.1537-2995.2002.00021.x – ident: e_1_2_8_3_2 doi: 10.1046/j.1537-2995.1998.38198141508.x – ident: e_1_2_8_14_2 doi: 10.1111/j.1537-2995.2007.01171.x – ident: e_1_2_8_12_2 doi: 10.1111/j.1751-1097.2005.tb00210.x – ident: e_1_2_8_27_2 doi: 10.1016/S0887-7963(92)70166-7 – ident: e_1_2_8_8_2 doi: 10.1111/j.0041-1132.2004.00657.x – ident: e_1_2_8_10_2 doi: 10.1111/j.1751-1097.2004.tb00043.x – ident: e_1_2_8_29_2 doi: 10.1111/j.1537-2995.2010.02704.x – ident: e_1_2_8_6_2 doi: 10.1016/j.blre.2007.07.003 – ident: e_1_2_8_7_2 doi: 10.1182/blood-2008-10-167643 – ident: e_1_2_8_24_2 doi: 10.1111/j.1537-2995.2008.01642.x – ident: e_1_2_8_15_2 doi: 10.1111/j.1365-2141.1980.tb07189.x – ident: e_1_2_8_28_2 doi: 10.1111/j.1432-1033.1981.tb05246.x – ident: e_1_2_8_25_2 doi: 10.1046/j.1537-2995.1999.39299154725.x – ident: e_1_2_8_30_2 doi: 10.1097/01.ta.0000222671.84335.64 – ident: e_1_2_8_4_2 doi: 10.1111/j.1537-2995.2005.00583.x – ident: e_1_2_8_23_2 doi: 10.1016/j.biologicals.2009.10.019 – ident: e_1_2_8_16_2 doi: 10.1111/j.1365-2141.1992.tb04602.x – ident: e_1_2_8_17_2 doi: 10.1111/j.1537-2995.2009.02272.x – ident: e_1_2_8_21_2 doi: 10.1111/j.1537-2995.2006.00973.x – ident: e_1_2_8_18_2 doi: 10.1016/j.transci.2009.09.006 – ident: e_1_2_8_5_2 doi: 10.1213/ane.0b013e3181930a6e – ident: e_1_2_8_19_2 doi: 10.1111/j.1537-2995.2009.02517.x – ident: e_1_2_8_13_2 doi: 10.1111/j.1423-0410.1975.tb02756.x – ident: e_1_2_8_11_2 doi: 10.1016/j.biologicals.2009.10.016 – ident: e_1_2_8_9_2 doi: 10.1111/j.1537-2995.2006.00939.x – volume: 95 start-page: 8 issue: 1 year: 2008 ident: e_1_2_8_22_2 article-title: A randomized, controlled, 2‐period crossover study of recovery and lifespan of radiolabeled autologous 35‐day‐old red blood cells prepared with a modified S‐303 treatment for pathogen inactivation publication-title: Vox Sang – ident: e_1_2_8_31_2 doi: 10.1097/CCM.0b013e31817e2ef9 – year: 2010 ident: e_1_2_8_2_2 article-title: A comparison of methods of pathogen inactivation of FFP publication-title: Vox Sang – ident: e_1_2_8_26_2 doi: 10.1111/j.1537-2995.2005.00582.x |
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| Snippet | BACKGROUND: A novel system using ultraviolet (UV) light and riboflavin (Mirasol System, CaridianBCT Biotechnologies) to fragment nucleic acids has been... BACKGROUND: A novel system using ultraviolet (UV) light and riboflavin (Mirasol System, CaridianBCT Biotechnologies) to fragment nucleic acids has been... A novel system using ultraviolet (UV) light and riboflavin (Mirasol System, CaridianBCT Biotechnologies) to fragment nucleic acids has been developed to treat... |
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| SubjectTerms | Adenosine Triphosphate - analysis Anesthesia. Intensive care medicine. Transfusions. Cell therapy and gene therapy Biological and medical sciences Blood Blood Preservation - methods Blood Preservation - standards Blood. Blood and plasma substitutes. Blood products. Blood cells. Blood typing. Plasmapheresis. Apheresis Bone marrow, stem cells transplantation. Graft versus host reaction Cell Survival - drug effects Cell Survival - radiation effects Erythrocytes - cytology Erythrocytes - drug effects Hemolysis - drug effects Hemolysis - radiation effects Humans Medical sciences Predictive Value of Tests Riboflavin - pharmacology Transfusions. Complications. Transfusion reactions. Cell and gene therapy Ultraviolet Rays - adverse effects |
| Title | In vivo viability of stored red blood cells derived from riboflavin plus ultraviolet light-treated whole blood |
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