Academic emergency medicine : official journal of the Society for Academic Emergency Medicine
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In 1996, federal regulations were put into effect that allowed enrollment of critically ill or injured patients into Food and Drug Administration (FDA)-regulated clinical trials using an exception from informed consent (EFIC) under narrowly prescribed research circumstances. Despite the low likelihood that a legally authorized representative (LAR) would be present within the interventional time frame, the EFIC regulations require the availability of an informed consent process, to be applied if an LAR is present and able to provide prospective consent for patient enrollment into the trial. The purpose of this article is to describe a series of unanticipated consent-related questions arising when a potential surrogate decision-maker appeared to be available at the time of patient enrollment into a trial proceeding under EFIC.
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To prevent unnecessary antivenom administration in crotaline snakebite, observation for progression is recommended for the patient with minor envenomation whose condition is stable and not progressing. The objective of this study was to determine the association between the time from bite to initial antivenom administration (Time(AV)) and the total amount of antivenom administered (Total(AV)) and to determine what proportion of patients did not have progression of the envenomation syndrome and did not receive antivenom. ⋯ Time(AV) was not associated with Total(AV) when adjusted for likely confounders and supports current recommendations to observe for progression in minor envenomation. The majority of envenomations progressed, resulting in only a small proportion of patients not eventually receiving antivenom. The authors recommend observation in an environment where the patient can be adequately reassessed for progression of the envenomation.
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The objective was to compare systolic blood pressure (sBP) over time in swine that have had 30% of their blood volume removed (Class III shock) and treated with intravenous (IV) whole blood or IV hydroxocobalamin, compared to nontreated control animals. ⋯ Intravenous hydroxocobalamin was more effective than no treatment and as effective as whole blood transfusion, in reversing hypotension and inhibiting rises in serum lactate in this prehospital, controlled, Class III swine hemorrhage model.