Methods and treatment of trauma adverse events with oxygen reduced blood
Inventors
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Assignees
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HemanextHemanext is a privately held medical technology company specializing in oxygen-controlled red blood cell processing and storage systems for transfusion medicine. The company develops, manufactures, and commercializes innovative storage solutions that preserve the quality and function of red blood cells by limiting oxygen and carbon dioxide exposure, with the goal of improving transfusion outcomes for patients with chronic and acute conditions. Hemanext's products have received FDA De Novo marketing authorization and CE Mark certification, enabling global distribution. The company is recognized for its focus on scientific evidence, operational compatibility, and strategic partnerships with blood establishments and clinical researchers.
Hemanext is a privately held medical technology company specializing in oxygen-controlled red blood cell processing and storage systems for transfusion medicine. The company develops, manufactures, and commercializes innovative storage solutions that preserve the quality and function of red blood cells by limiting oxygen and carbon dioxide exposure, with the goal of improving transfusion outcomes for patients with chronic and acute conditions. Hemanext's products have received FDA De Novo marketing authorization and CE Mark certification, enabling global distribution. The company is recognized for its focus on scientific evidence, operational compatibility, and strategic partnerships with blood establishments and clinical researchers.
Publication Number
US-11576931-B2
Publication Date
2023-02-14
Expiration Date
Abstract
Methods for the reversal of hemorrhagic shock or hemorrhagic trauma. Methods for restoring mean arterial pressure to a normal range and reducing trauma adverse risks in a patient through the administration of oxygen reduced blood compositions.
Core Innovation
The invention discloses treating hemorrhagic trauma and hemorrhagic shock by transfusing stored oxygen-reduced (OR) or oxygen- and carbon-dioxide-reduced (OCR) blood products. The disclosure specifies [procedural detail omitted for safety] and presents in vivo hemorrhagic shock data showing improved storage quality with higher ATP and 2,3-DPG during storage, increased 24-hour red blood cell recovery, and improved clinical outcomes compared to conventionally stored blood.
In a hemorrhage/resuscitation model OR/OCR transfusion requires less volume to restore hemodynamics and accelerates recovery of physiological and metabolic parameters. The disclosure addresses trauma patients in need of transfusion therapy who present with elevated blood glucose and indicators of organ injury or dysfunction, and aims to lower blood glucose, promote lactate clearance, restore mean arterial pressure and hematocrit, and reduce markers of liver and kidney injury and inflammation.
Claims Coverage
One independent claim is asserted, encompassing six inventive features covering a method to reduce elevated blood glucose in a trauma patient by administering stored oxygen-reduced blood, with defined product characteristics and comparative efficacy.
Administration of stored oxygen-reduced blood to reduce blood glucose in trauma patients
A method comprising administering stored oxygen-reduced blood to a trauma patient who has an elevated blood glucose level, wherein the blood glucose level is reduced after administration.
Stored blood having a reduced oxygen saturation prior to storage
The administered blood product is characterized by a reduced oxygen saturation level prior to storage.
Applicability to trauma patients with elevated blood glucose
The trauma patient comprises a blood glucose level that is elevated prior to said administering, and wherein said blood glucose level is reduced after said administering.
Oxygen- and carbon dioxide-reduced blood product
A variant of the stored blood is also reduced in carbon dioxide prior to storage with specified pCO2 parameters [procedural detail omitted for safety].
Comparative glucose reduction versus conventional stored blood
The claimed post-administration reduction in blood glucose is defined as greater than the reduction observed after administering non-oxygen-reduced blood stored under conventional conditions [procedural detail omitted for safety].
Selection from enumerated blood product types
The reduced-oxygen blood product is selected from a defined list of blood product types including oxygen-reduced whole blood and various oxygen-reduced packed, leukoreduced, and platelet-reduced red blood cell products.
The claims cover a transfusion method that uses stored blood with reduced oxygen content (and optionally reduced carbon dioxide) administered to trauma patients with elevated glucose, with asserted superior glucose reduction and a defined set of selectable blood product types.
Stated Advantages
Improved storage quality, including higher ATP and 2,3-DPG during storage and improved 24-hour red blood cell recovery compared to conventionally stored blood.
Improved resuscitation outcomes, including requirement of less transfusion volume to restore hemodynamics and faster restoration of mean arterial pressure and hematocrit.
Faster metabolic recovery, including more rapid reduction of lactate and hyperglycemia.
Reduced organ injury and inflammation markers, including decreases in serum creatinine, blood urea nitrogen (BUN), AST/ALT, CXCL1, IL-6, u-NGAL, and CD45+ neutrophils.
Documented Applications
Hemorrhagic trauma
Surgery-related hemorrhage
Transfusion therapy for hemorrhagic shock
Transfusion therapy to reduce elevated blood glucose in a trauma patient in need of transfusion.
Resuscitation in a hemorrhagic shock model (rat hemorrhagic shock resuscitation model) to improve hemodynamics, metabolic recovery, and decrease organ injury and inflammation.
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