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-11026971-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 provides methods of treating hemorrhagic trauma by administering stored oxygen‑reduced blood or oxygen‑and‑carbon‑dioxide‑reduced blood that comprise a blood product having a reduced oxygen saturation level prior to storage for a storage period. It reduces the risk of hemorrhagic trauma adverse events, specifically liver injury and liver damage, relative to a patient receiving conventionally stored blood. Preparation, oxygen saturation thresholds, storage durations, and additive solutions are [procedural detail omitted for safety].
The patent addresses improving storage metrics and post‑transfusion outcomes versus conventionally stored blood. Documented data in a rat hemorrhagic shock/resuscitation model show higher ATP and 2,3‑DPG during storage, improved 24‑hour in vivo recovery with reduced microparticles, faster restoration of hematocrit and greater mean arterial pressure with less transfused volume, more rapid normalization of lactate and glucose, reduced liver injury markers, and improved kidney and inflammatory markers.
Claims Coverage
Two independent claims (1 and 13) are identified; five inventive features are extracted, covering methods of administering stored oxygen‑reduced blood to hemorrhagic trauma subjects to reduce liver‑related adverse outcomes.
Administering stored oxygen reduced blood
A method comprising administering stored oxygen reduced blood to a subject having hemorrhagic trauma to reduce the risk of a hemorrhagic trauma adverse event.
Stored oxygen reduced blood having a reduced oxygen saturation level prior to storage
Stored oxygen reduced blood comprising a blood product having a reduced oxygen saturation level prior to storage for a storage period.
Reduced risk of liver injury relative to conventionally stored blood
Wherein the hemorrhagic trauma adverse event is liver injury and said risk is reduced relative to a patient receiving conventionally stored blood.
Subject has increased levels of AST, ALT, or both
Hemorrhagic trauma subject has increased levels of aspartate aminotransferase (AST), increased levels of alanine aminotransferase (ALT), or both AST and ALT.
Reduction in risk of liver damage relative to conventionally stored blood
Wherein said risk of liver damage is reduced relative to a patient receiving conventionally stored blood.
The independent claims center on administering blood products that are oxygen‑reduced prior to storage to hemorrhagic trauma subjects to reduce liver injury or liver damage relative to conventionally stored blood, with product characteristics reciting reduced oxygen saturation prior to storage and patient selection that can include elevated AST and/or ALT.
Stated Advantages
Improved storage quality metrics, including higher ATP, 2,3‑DPG, improved 24‑hour in vivo recovery, and reduced microparticles.
Faster and greater restoration of mean arterial pressure and hematocrit with less transfused volume.
More rapid normalization of metabolic markers, including lactate and glucose.
Reduced liver injury markers (reduced AST and ALT) and reduced risk of liver damage relative to conventionally stored blood.
Improved kidney markers (reduced serum creatinine and BUN) and decreased inflammation (reduced CXCL1, IL‑6, u‑NGAL and percent CD45+ neutrophils).
Documented Applications
Treatment of hemorrhagic trauma subjects to reduce the risk of liver injury.
Method for reducing the risk of liver damage in hemorrhagic trauma subjects with increased AST and/or ALT by administering stored oxygen reduced blood.
Resuscitation in a hemorrhagic shock model, as demonstrated in a rat hemorrhagic shock/resuscitation model.
Use for patient populations and indications including classes I–IV hemorrhage, surgical risk settings, and subjects with comorbidities.
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