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The main purpose of this study is to determine if HBOC-201 is safe and tolerable to trauma subjects, when given to treat the inadequate supply of blood and nutrients to tissues and organs.
Full description
This Phase II study will be a single-center, randomized, single-blind, parallel-group, standard therapy-controlled, variable dose study of HBOC 201 administered to trauma subjects with bleeding or potential for bleeding who require standard fluid therapy for treatment of hypoperfusion. The type and incidence of adverse events and serious adverse events attributed to the study drug will be analyzed.
Secondary variables in this safety and tolerability study, will be summarized with descriptive statistics and frequency tables. The purpose of this data collection is to assess efficacy variables and the feasibility of utilizing these parameters in future trauma studies that will assess parameters of morbidity and mortality and include, but are not limited to:
Hemorrhage with subsequent hypoperfusion is a major cause of both immediate and delayed death in subjects who have sustained traumatic injuries. Effective therapies for hemorrhage to treat hypoperfusion that can be given immediately following injury are lacking. The following issues confound this problem further:
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Inclusion criteria
Systolic Blood Pressure ≤ 100 mm Hg OR Sustained (≥ 10 minutes) Heart Rate ≥ 100
Exclusion criteria
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Interventional model
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53 participants in 2 patient groups
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Central trial contact
Tiana Gorham
Data sourced from clinicaltrials.gov
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