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-10898517-B2
Publication Date
2021-01-26
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 to treat hemorrhagic trauma and shock by transfusing oxygen-reduced (OR) or oxygen-and-carbon-dioxide-reduced (OCR) stored red blood cells, wherein the blood product has a reduced oxygen saturation level prior to and during storage for a storage period. Oxygen saturation embodiments [procedural detail omitted for safety], and compatible additive solutions [procedural detail omitted for safety] are disclosed for use with low-O2 storage. The method compares outcomes to conventionally stored blood.
The invention addresses subjects having low mean arterial pressure by increasing arterial pressure through administration of stored oxygen reduced blood, wherein the pressure is increased relative to conventionally stored blood. The approach preserves ATP and 2,3-DPG, improves 24-hour recovery and lactate clearance, accelerates mean arterial pressure restoration with less transfused volume [procedural detail omitted for safety], normalizes glucose, improves hematocrit recovery, and reduces markers of organ injury, dysfunction, and inflammation.
Claims Coverage
One independent claim is present and three main inventive features are identified.
Administering stored oxygen reduced blood to increase arterial pressure
A method for increasing arterial pressure in a hemorrhagic trauma subject in need thereof having a low mean arterial pressure comprising administering stored oxygen reduced blood to said subject.
Stored oxygen reduced blood having 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.
Increased arterial pressure relative to conventionally stored blood
Wherein said low mean arterial pressure in said hemorrhagic trauma subject is increased relative to a patient administered conventionally stored blood.
The independent claim covers administering a blood product whose oxygen saturation is reduced prior to storage to increase arterial pressure in hemorrhagic trauma subjects, with the increase measured relative to administration of conventionally stored blood.
Stated Advantages
Preservation of ATP and 2,3-DPG in stored red blood cells.
Improved 24-hour recovery following transfusion.
Accelerated and increased mean arterial pressure restoration with reduced transfusion volume [procedural detail omitted for safety].
Quicker normalization of lactate and glucose and better hematocrit recovery following transfusion.
Reduction in markers of organ injury and dysfunction, including lower lactate, reduced AST and ALT, reduced u-NGAL, reduced serum creatinine and BUN, and reduced inflammatory markers (CXCL1, IL-6, CD45+ neutrophils).
Increases mean arterial pressure in hemorrhagic trauma subjects relative to conventionally stored blood.
Documented Applications
Treatment of hemorrhagic trauma and shock subjects in need of increased arterial pressure by administering stored oxygen-reduced or oxygen-and-carbon-dioxide-reduced red blood cells.
Use in resuscitation contexts to accelerate mean arterial pressure restoration, reduce transfusion volume, and mitigate organ injury and dysfunction following hemorrhagic shock, as demonstrated in [procedural detail omitted for safety].
Administration to hemorrhagic trauma subjects characterized by increased urine neutrophil gelatinase-associated lipocalin (u-NGAL) prior to administering.
Administration to hemorrhagic trauma subjects characterized by decreased hematocrit prior to administering.
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