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-11033581-B2
Publication Date
2021-06-15
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 hypoxically stored blood and a method to reduce the amount of stored blood needed for transfusion in hemorrhagic trauma and shock by obtaining blood with low initial oxygen saturation and storing it under anaerobic conditions. Oxygen‑reduced (OR) and oxygen‑and‑carbon‑dioxide‑reduced (OCR) stored red blood cells improve resuscitation outcomes versus conventionally stored blood, as experimental evidence in a rat hemorrhagic shock model demonstrates improved efficacy with lower transfused volumes.
The problem being solved is that conventionally stored blood is less effective for resuscitation of hemorrhagic trauma patients in shock with elevated blood lactate, often necessitating larger transfused volumes and associating with worsened metabolic, organ‑injury, and inflammatory markers. The invention reduces the amount of blood needed while accelerating lactate clearance, restoring hemodynamics, and lowering biomarkers of organ injury and inflammation, thereby reversing shock and improving resuscitation quality relative to conventionally stored blood.
Hypoxically stored red blood cells preserve ATP and 2,3‑DPG and exhibit lower hemolysis during storage, resulting in greater 24‑hour post‑transfusion recovery. Transfusion restores hematocrit and mean arterial pressure faster and to higher levels with substantially less volume, rapidly reduces lactate and glucose toward normal, and reduces liver injury markers while preserving kidney function. Reduced inflammation is observed by decreases in CXCL1, IL‑6, CD45+ neutrophils, and u‑NGAL. Methods are described [procedural detail omitted for safety].
Claims Coverage
The claims include one independent method claim with four main inventive features directed to obtaining low‑oxygen blood, anaerobic storage to form hypoxically stored blood, administration to hemorrhagic trauma patients with elevated lactate and shock, and achieving lactate reduction and shock reversal using a reduced transfusion volume compared to conventionally stored blood.
Blood having an oxygen saturation of 20% or less
Obtaining blood having an oxygen saturation of 20% or less.
Storing blood under anaerobic conditions to form hypoxically stored blood
Storing said blood under anaerobic conditions to form hypoxically stored blood.
Providing hypoxically stored blood to a hemorrhagic trauma patient
Providing said hypoxically stored blood to a hemorrhagic trauma patient in need of a blood transfusion who has elevated blood lactate levels and is in a shock state.
Using reduced amount of hypoxically stored blood to reverse shock and reduce lactate
Reducing elevated blood lactate levels and reversing the shock state using a reduced amount of hypoxically stored blood compared to conventionally stored blood.
The independent claim centers on (1) sourcing low‑oxygen blood, (2) anaerobic storage to create hypoxically stored blood, (3) transfusing that hypoxically stored blood to hemorrhagic trauma patients with elevated lactate and shock, and (4) achieving lactate reduction and shock reversal with less transfused volume than conventionally stored blood.
Stated Advantages
Substantially reduced transfused blood volume required for resuscitation (examples recite reductions in the range of 10–95% and embodiments recite ≥50% reduction).
Preservation of metabolic markers ATP and 2,3‑DPG and lower hemolysis during storage.
Greater 24‑hour RBC recovery relative to conventionally stored blood.
Faster restoration of hematocrit and mean arterial pressure with less transfused volume.
Accelerated lactate clearance to specified post‑transfusion targets and lowered blood glucose to specified targets.
Reduced organ‑injury biomarkers (AST, ALT) and preserved kidney function with reductions in serum creatinine, BUN, and u‑NGAL.
Reduced inflammatory responses as evidenced by reduced CXCL1, IL‑6, and CD45+ neutrophils.
Documented Applications
Resuscitation and transfusion of hemorrhagic trauma patients in shock with elevated blood lactate.
Use in hemorrhagic shock resuscitation to reverse shock and reduce elevated blood lactate levels.
Applications demonstrating improved organ protection and reduced inflammation during resuscitation, as supported by experimental results in a rat hemorrhagic shock model.
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