Methods and treatment of trauma adverse events with oxygen reduced blood
Inventors
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Assignees
MemberHemanextHemanextHemanext 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-11026970-B2
Publication Date
2021-06-08
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 methods to treat hemorrhagic trauma and hemorrhagic shock by administering stored oxygen-reduced (OR) or oxygen-and-carbon-dioxide-reduced (OCR) red blood cell products that have a reduced oxygen saturation level after storage. The disclosure specifies product characteristics and compatible additive solutions and contemplates storage over standard storage periods. The method reduces risk of organ damage relative to a patient receiving conventionally stored blood and frames OR/OCR units as an alternative for resuscitation.
The problem being solved is reducing organ damage and improving hemodynamic and metabolic outcomes in hemorrhagic trauma. OR/OCR units preserve ATP and 2,3-DPG, improve 24-hour in vivo recovery, restore mean arterial pressure faster and to higher levels, more rapidly restore hematocrit, and normalize lactate and glucose while reducing transfused blood volume. The disclosure reports reduced organ-injury biomarkers and inflammatory markers relative to conventionally stored blood.
Claims Coverage
One independent claim is present and it defines three main inventive features directed to administration, a stored blood product having reduced oxygen saturation after storage, and a comparative clinical outcome versus conventionally stored blood.
Administering stored oxygen-reduced blood
A method comprising administering stored oxygen reduced blood to a subject having hemorrhagic trauma.
Stored blood having reduced oxygen saturation after storage
The stored blood product is characterized by a reduced oxygen saturation level compared to an oxygen saturation level prior to storage for a storage period.
Reducing risk of organ damage relative to conventionally stored blood
The method is claimed to reduce the risk of organ damage in the hemorrhagic trauma subject relative to a patient receiving conventionally stored blood.
The independent claim centers on administering a stored blood product with reduced oxygen saturation to hemorrhagic trauma subjects to achieve a reduced risk of organ damage compared with conventionally stored blood.
Stated Advantages
Reduced risk of organ damage in hemorrhagic trauma subjects relative to conventionally stored blood.
Faster restoration of mean arterial pressure and to higher levels after transfusion.
Reduced transfused blood volume required to achieve resuscitation endpoints.
Preservation of red blood cell energy and oxygen-delivery metabolites (ATP and 2,3-DPG) during storage.
Improved 24-hour in vivo recovery of transfused red blood cells.
Reduced markers of organ injury and inflammation, including reductions in AST, ALT, serum creatinine, BUN, CXCL1, IL-6, u-NGAL, and CD45+ neutrophils, with reported >30% reductions for some endpoints.
Faster normalization of lactate and glucose following hemorrhagic shock/resuscitation.
Reduced hemolysis, microparticles, and oxidation, and improved deformability versus conventionally stored blood.
More rapid restoration of hematocrit.
Documented Applications
Treatment of hemorrhagic trauma and hemorrhagic shock by administering stored oxygen-reduced (OR) or oxygen-and-carbon-dioxide-reduced (OCR) red blood cell products.
Resuscitation in a hemorrhagic shock model with the aim of restoring mean arterial pressure and reducing transfusion volume.
Reduction of organ injury to liver, kidney, and lung in the context of hemorrhagic trauma.
Preclinical demonstration in a rat hemorrhagic shock/resuscitation model providing in vivo evidence of preserved ATP and 2,3-DPG, improved recovery, hemodynamic benefits, and reduced biomarkers.
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