Methods for the Storage of Whole Blood, and Compositions Thereof

Abstract

Methods and compositions for improved clinical outcomes for trauma patients receiving whole blood transfusion. Methods and compositions for improved clinical outcomes for blood transfusions for cancer patients are also provided.

1 .- 34 . (canceled) 
     
     
         35 . A leukoreduced whole blood composition for transfusion to a trauma patient in need of multiple transfusions comprising:
 oxygen and carbon dioxide reduced leukoreduced whole blood (OCR-LRWB), and   having a pre-storage and storage oxygen saturation (SO 2 ) of 30% or less and a pre-storage and storage partial pressure of carbon dioxide of less than 60 mmHg, and   having a 2,3-DPG level at 15 days that is greater than the initial 2,3-DPG level of said oxygen and carbon dioxide leukoreduced whole blood (OCR-LRWB).   
     
     
         36 . The blood composition of  claim 35 , wherein the 2,3-DPG level of said OCR-LRWB is at least 80% or higher than the 2,3-DPG level of the blood at day zero. 
     
     
         37 . The blood composition of  claim 35 , wherein the 2,3-DPG level of said OCR-LRWB is at least 5 to 20 DPG μmol/gHb after 15 days of storage. 
     
     
         38 . The blood composition of  35 , wherein said pre-storage oxygen saturation is less than 20%. 
     
     
         39 . The blood composition of  claim 35 , wherein said pre-storage partial pressure of carbon dioxide is between 1 and 60 mmHg. 
     
     
         40 . The blood composition of  claim 35 , wherein said OCR-LRWB comprises an anticoagulant solution selected from citrate-phosphate-dextrose with adenine (CPDA1) or citrate-phosphate-dextrose (CPD). 
     
     
         41 . The blood composition of  claim 35 , wherein said oxygen and carbon dioxide leukoreduced whole blood (OCR-LRWB) has reduced levels of a biologic response modifier (BRM) selected from the group consisting of a cytokine, a chemokine, an isoprostane, and an oxidized lipid product relative to non-oxygen and carbon dioxide leukoreduced whole blood (non-OCR-LRWB). 
     
     
         42 . The blood composition of  claim 41 , wherein a patient transfused with said oxygen and carbon dioxide leukoreduced whole blood (OCR-LRWB) has a reduced inflammatory response relative to a patient transfused with non-OCR-LRWB. 
     
     
         43 . The blood composition of  claim 41 , wherein a patient transfused with said oxygen and carbon dioxide leukoreduced whole blood (OCR-LRWB) has a reduced immune modulation relative to a patient transfused with non-OCR-LRWB. 
     
     
         44 . The blood composition of  claim 41 , wherein a patient transfused with said oxygen and carbon dioxide leukoreduced whole blood (OCR-LRWB) has a reduced risk of multiple organ dysfunction relative to a patient transfused with non-OCR-LRWB. 
     
     
         45 . The blood composition of  claim 41 , wherein a patient transfused with said oxygen and carbon dioxide leukoreduced whole blood (OCR-LRWB) has a reduced risk of sepsis relative to a patient transfused with non-OCR-LRWB. 
     
     
         46 . The blood composition of  claim 41 , wherein a patient transfused with said oxygen and carbon dioxide leukoreduced whole blood (OCR-LRWB) has a reduced risk of infection relative to a patient transfused with non-OCR-LRWB. 
     
     
         47 . The blood composition of  claim 41 , wherein a patient transfused with said oxygen and carbon dioxide leukoreduced whole blood (OCR-LRWB) has a reduced risk of mortality relative to a patient transfused with non-OCR-LRWB. 
     
     
         48 . The blood composition of  claim 41 , wherein a patient transfused with said oxygen and carbon dioxide leukoreduced whole blood (OCR-LRWB) has a higher red blood cell (RBC) deformability relative to a patient transfused with non-OCR-LRWB. 
     
     
         49 . The blood composition of  claim 41 , wherein said blood has equivalent or better coagulation parameters measured by thromboelastography (TEG) when compared to non-OCR-LRWB. 
     
     
         50 . The blood composition of  claim 41 , wherein said blood has equivalent or better coagulation parameters as determined by PT/PTT, fibrinogen, D-dimer, and thrombin generation assays when compared to non-OCR-LRWB. 
     
     
         51 . The blood composition of any one of  claim 41 , wherein said blood has equivalent or better platelet function parameters measured by platelet aggregometer when compared to non-OCR-LRWB. 
     
     
         52 . The blood composition of any one of  claim 41 , wherein said blood has equivalent or better levels of clotting factors including Factor V, Factor VIII, AT, Protein C, or vWF when compared to non-OCR-LRWB. 
     
     
         53 . The blood composition of  claim 41 , wherein said blood is safe for transfusion into a patient in need thereof for at least three weeks. 
     
     
         54 .- 88 . (canceled) 
     
     
         89 . The blood composition of  claim 35 , wherein said pre-storage oxygen saturation is less than 10% or less than 5%. 
     
     
         90 . The blood composition of  claim 39 , wherein said pre-storage partial pressure of carbon dioxide is between 10 and 60 mmHg, 20 and 40 mmHg, or 1 and 20 mmHg. 
     
     
         91 . The blood composition of  claim 35 , wherein said patient in need of multiple transfusions is a trauma patient, transplant patient, cardiac surgery patient, obstetrics patient, GI surgery patient, cancer patient, or orthopedic surgery patient.