US2023028174A1PendingUtilityA1

Methods for the Storage of Whole Blood, and Compositions Thereof

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Assignee: HEMANEXT INCPriority: May 18, 2015Filed: Sep 27, 2022Published: Jan 26, 2023
Est. expiryMay 18, 2035(~8.8 yrs left)· nominal 20-yr term from priority
Inventors:Tatsuro Yoshida
A61K 35/14A61P 43/00A61P 7/00A61K 35/18A61M 1/0272A61M 2202/0427A61M 1/0281A61M 1/3609A61M 1/36A61P 35/00A61P 25/00
75
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Claims

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.

Claims

exact text as granted — not AI-modified
1 .- 34 . (canceled) 
     
     
         35 . An oxygen reduced stored whole blood composition with platelets (OR-WB+PLT) for transfusion to a trauma patient in need thereof comprising OR-WB+PLT in an anticoagulant solution, having a pre-storage and storage oxygen saturation (SO 2 ) of 30% or less and stored for a storage period, wherein the stored OR-WB+PLT has one or more coagulation parameters that are equivalent to or better than the same one or more coagulation parameters in conventionally stored non-oxygen reduced whole blood with platelets (non-OR-WB+PLT). 
     
     
         36 .- 48 . (canceled) 
     
     
         49 . The oxygen reduced stored whole blood composition with platelets (OR-WB+PLT) of  claim 35 , wherein the one or more coagulation parameters are measured by thromboelastography (TEG), wherein the one or more coagulation parameters are selected from the group consisting of thromboelastography angle (TEG angle), thromboelastography kinetic value (TEG K), thromboelastography maximum amplitude (TEG MA), and thromboelastography reaction time (TEG R). 
     
     
         50 .- 88 . (canceled) 
     
     
         89 . The oxygen reduced stored whole blood composition with platelets (OR-WB+PLT) of  claim 49 , wherein the TEG angle is more than 40°. 
     
     
         90 . The oxygen reduced stored whole blood composition with platelets (OR-WB+PLT) of  claim 49 , wherein the TEG K is between 1 minute to 5 minutes. 
     
     
         91 . The oxygen reduced stored whole blood composition with platelets (OR-WB+PLT) of  claim 49 , wherein the TEG MA is between 35 millimeters (mm) to 65 mm. 
     
     
         92 . The oxygen reduced stored whole blood composition with platelets (OR-WB+PLT) of  claim 49 , wherein the TEG R is between 4 minutes to 8 minutes. 
     
     
         93 . The oxygen reduced stored whole blood composition with platelets (OR-WB+PLT) of  claim 35 , wherein the one or more coagulation parameters are selected from the group consisting of prothrombin time (PT), partial thromboplastin time (PTT), fibrinogen level, D-dimer value, and thrombin generation value. 
     
     
         94 . The oxygen reduced stored whole blood composition with platelets (OR-WB+PLT) of  claim 93 , wherein the PT is between 10 seconds to 15 seconds. 
     
     
         95 . The oxygen reduced stored whole blood composition with platelets (OR-WB+PLT) of  claim 93 , wherein the PTT is between 32 seconds to 42 seconds. 
     
     
         96 . The oxygen reduced stored whole blood composition with platelets (OR-WB+PLT) of  claim 93 , wherein the fibrinogen level is between 250 milligrams per deciliter (mg/dL) to 350 mg/dL. 
     
     
         97 . The oxygen reduced stored whole blood composition with platelets (OR-WB+PLT) of  claim 35 , wherein the stored OR-WB+PLT has platelet function parameters that are equivalent to or better than platelet function parameters in conventionally stored non-oxygen reduced whole blood with platelets (non-OR-WB+PLT). 
     
     
         98 . The oxygen reduced stored whole blood composition with platelets (OR-WB+PLT) of  claim 97 , wherein the platelet function parameters are measured by platelet aggregometry. 
     
     
         99 . The oxygen reduced stored whole blood composition with platelets (OR-WB+PLT) of  claim 35 , wherein the stored OR-WB+PLT has a level of a clotting factor that is equivalent to or better than a level of the same clotting factor in conventionally stored non-oxygen reduced whole blood with platelets (non-OR-WB+PLT). 
     
     
         100 . The oxygen reduced stored whole blood composition with platelets (OR-WB+PLT) of  claim 99 , wherein the clotting factor is selected from the group consisting of Factor V, Factor VIII, antithrombin (AT), Protein C, Von Willebrand Factor (vWF), and any combination thereof. 
     
     
         101 . The oxygen reduced stored whole blood composition with platelets (OR-WB+PLT) of  claim 35 , wherein the stored OR-WB+PLT has higher red blood cell (RBC) deformability compared to RBC deformability of conventionally stored non-oxygen reduced whole blood with platelets (non-OR-WB+PLT). 
     
     
         102 . The oxygen reduced stored whole blood composition with platelets (OR-WB+PLT) of  claim 35 , wherein the anticoagulant solution is selected from the group consisting of citrate-phosphate-dextrose (CPD), citrate-phosphate-dextrose-adenine solution 1 (CPDA-1), acid-citrate-dextrose (ACD), and acid-citrate-dextrose solution A (ACD-A). 
     
     
         103 . The oxygen reduced stored whole blood composition with platelets (OR-WB+PLT) of  claim 35 , wherein the trauma patient in need thereof is in need of multiple blood transfusions. 
     
     
         104 . The oxygen reduced stored whole blood composition with platelets (OR-WB+PLT) of  claim 35 , wherein the trauma patient in need thereof is a hemorrhagic trauma patient or a blunt trauma patient. 
     
     
         105 . The oxygen reduced stored whole blood composition with platelets (OR-WB+PLT) of  claim 35 , wherein the storage period is two weeks, three weeks, or more than three weeks. 
     
     
         106 . The oxygen reduced stored whole blood composition with platelets (OR-WB+PLT) of  claim 35 , wherein the stored OR-WB+PLT is safe for transfusion into the trauma patient in need thereof for at least a three week period of time.

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