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Description: HBOC-201 is a bovine polymerized HBOC that is universally compatible, does not require refrigeration or special training for administration, and has been evaluated in over 800 volunteers and surgery patients. The sponsor, Biopure Corp., completed a phase III perioperative orthopedic trial in over 600 patients and submitted a BLA to the FDA (currently under review) for orthopedic perioperative use. The HBOC trial will be completed in two stages. Stage I will consist of a phase IIb trial in fifty subjects in five U.S. trauma centers. Stage II will consist of a pivotal phase III trial in approximately 1,100 subjects in up to 25 trauma centers. Prehospital patients with severe hemorrhagic shock without severe traumatic brain injury will be randomly assigned to receive HBOC-201 or Lactated Ringer's solution in the field. All other care will be standard, as per Advanced Trauma Life Support (ATLS) or similar protocols. Enrolled subjects will then be followed for up to 28 days. Primary and secondary outcome measurements will be mortality, and markers and surrogates of morbidity and mortality, respectively.
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| Biopure, Corp |
$5,132 |
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For-Profit |
Cambridge,
MA
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Citation
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Source:
Appropriations Report Language - Conference
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Reference:
108-622
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Location:
Line 130, Page 303
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Citation Excerpt: Room Elevated Temperature Stable Hemoglobin-based Oxygen Carrier
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