J Trauma
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Randomized Controlled Trial Multicenter Study
HBOC-201 vasoactivity in a phase III clinical trial in orthopedic surgery subjects--extrapolation of potential risk for acute trauma trials.
Vasoactivity has hampered progress of hemoglobin-based oxygen carriers (HBOCs) due to concern for adverse blood pressure responses and secondary complications. A recent formulation, highly polymerized HBOC-201 (Biopure, Cambridge, MA), has been found to be less vasoactive than prior less polymerized formulations, and to improve outcome in animal models of hemorrhagic shock (HS) compared with standard resuscitation fluids. HBOCs are envisioned to have life- saving potential for severe trauma patients for whom death due to HS is common despite transport to level I trauma centers. As part of a benefit:risk analysis for a proposed clinical trial of HBOC-201 in patients with traumatic HS, we analyzed data from a previous phase III clinical trial of this HBOC that involved orthopedic surgery patients, for vasoactivity and related effects, with focus on patients more representative of the trauma population. ⋯ Our limited HEM-0115 safety analysis shows that key potentially vasoactivity-related adverse safety signals were more frequent with HBOC-201 than RBC in older patients undergoing orthopedic surgery with rapid access to safe blood transfusions. That incidences of these safety signals were generally lower and group differences narrowed in subpopulations with stable trauma, hypotension, and younger age, suggests an acceptable safety profile in younger acute trauma populations, especially in settings where rapid access to safe blood transfusions is unavailable; confirmation in controlled clinical trials is urgently warranted.
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Randomized Controlled Trial
Autonomous control of inspired oxygen concentration during mechanical ventilation of the critically injured trauma patient.
Transport of mechanically ventilated patients in a combat zone presents challenges including conservation of resources. In the battlefield setting, the provision of adequate oxygen supplies remains a significant issue. Autonomous control of oxygen concentration may allow a reduction in mission load. ⋯ Autonomous control of FIO2 offers the opportunity for a reduction in oxygen usage, allowing a weight and resource reduction, without increasing risk of hypoxemia in ventilated trauma patients.