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-11052110-B2
Publication Date
2021-07-06
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 disclosure describes treating hemorrhagic trauma and hemorrhagic shock by transfusing oxygen-reduced (OR) or oxygen-and-carbon dioxide-reduced (OCR) stored red blood cells with reduced oxygen saturation prior to and during storage [procedural detail omitted for safety]. The processed blood improves storage quality markers such as increased ATP and 2,3-DPG and reduced hemolysis, and increases short-term red blood cell recovery.
In a hemorrhagic shock resuscitation model, administering oxygen-reduced or oxygen-and-carbon dioxide-reduced stored blood produces faster restoration of mean arterial pressure and hematocrit, more rapid reduction of lactate and glucose, and decreased organ injury and inflammation as indicated by reductions in AST, ALT, serum creatinine, BUN, CXCL1, IL-6, u-NGAL, and CD45+ neutrophils. Rat hemorrhagic-shock data show improved 24-hour recovery and reduced transfusion volume.
The invention addresses hemorrhagic trauma in subjects who present with increased lactate indicating hemorrhagic shock and elevated organ injury and inflammatory biomarkers. The methods disclose administering stored oxygen-reduced blood to reduce lactate, reverse hemorrhagic shock, and reduce biomarkers of organ injury and inflammation, using blood products prepared with [procedural detail omitted for safety].
The disclosure compares these oxygen-reduced or oxygen-and-carbon dioxide-reduced units to conventionally stored blood and reports superior physiological and biochemical outcomes. The disclosure provides quantitative benefit ranges and describes gas-exchange processing and storage [procedural detail omitted for safety]. The processed blood restores mean arterial pressure faster and to higher levels, lowers lactate to targeted ranges [procedural detail omitted for safety], and more rapidly reduces glucose, while decreasing inflammatory markers and organ injury.
Claims Coverage
Independent claim 1 recites four main inventive features relating to a method for reducing lactate in a hemorrhagic trauma subject through administration of a stored oxygen-reduced blood product with defined pre-storage oxygen saturation and an observed reduction in lactate after administration.
Method for reducing lactate in a hemorrhagic trauma subject
A method for reducing lactate levels in a hemorrhagic trauma subject comprising administering stored oxygen reduced blood to a subject in need thereof having hemorrhagic trauma, wherein the trauma patient comprises an increased lactate level indicating hemorrhagic shock prior to administering, and wherein the lactate level is reduced after administering.
Administering stored oxygen reduced blood
Administering stored oxygen reduced blood to a subject in need thereof having hemorrhagic trauma as the therapeutic act by which lactate reduction and reversal of hemorrhagic shock are achieved.
Blood product with reduced oxygen saturation prior to storage
Said stored oxygen reduced blood comprising a blood product having a reduced oxygen saturation level prior to storage for a storage period [procedural detail omitted for safety].
Reduction of lactate after administering
The method is characterized by the trauma patient having an increased lactate level prior to administering and by the lactate level being reduced after administering the stored oxygen reduced blood, with dependent claims specifying target ranges for the reduced lactate [procedural detail omitted for safety].
Claim 1 covers a therapeutic method targeting hemorrhagic trauma patients with elevated lactate by administering a stored blood product that is oxygen reduced prior to storage, where the reduced oxygen saturation of the blood product and the post-administration reduction in lactate are the central inventive elements.
Stated Advantages
Improved red blood cell storage quality, including increased ATP and 2,3-DPG and reduced hemolysis.
Increased short-term red blood cell recovery after transfusion.
Restores mean arterial pressure faster and to higher levels.
Faster restoration of hematocrit.
Reduces required transfusion volume by 10–90% compared to conventional stored blood.
Lowers lactate to targeted ranges [procedural detail omitted for safety].
More rapid reduction of glucose.
Decreased organ injury and inflammation as indicated by reductions in AST, ALT, serum creatinine, BUN, CXCL1, IL-6, u-NGAL, and CD45+ neutrophils.
Improves 24-hour recovery after transfusion.
Documented Applications
Treating hemorrhagic trauma and hemorrhagic shock by transfusing oxygen-reduced (OR) or oxygen-and-carbon dioxide-reduced (OCR) stored red blood cells to reduce lactate and reverse hemorrhagic shock.
Use in hemorrhagic shock resuscitation models to evaluate physiological, biochemical, and organ injury outcomes.
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