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Prehospital Use of Plasma for Traumatic Hemorrhage - PUPTH-IIA

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Virginia Commonwealth University Richmond United States

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The Prehospital Use of Plasma in Traumatic Hemorrhage PUPTH Trial was an investigator-initiated, prospective, randomized, open-label, non-blinded trial to determine the effect of pre-hospital administration of thawed blood plasma on mortality and coagulation response in severely-injured trauma patients 3 Reynolds et al. Operational stagnation in the early trial phases was corrected by implementing Incident Command Structure to trial organization. However prehospital deployment of thawed plasma was a significant and possibly non-sustainable cost burden to the hospital, and a major logistic burden to field personnel. Regulatory compliance demands consumed the major proportion of overall operating costs. Initial recruitment projections suggested 50 to 70 patients per year could be enrolled. However, only three patients were successfully enrolled in a five-month period. The decision was made to terminate the trial in December 2015. Prehospital use of thawed plasma for treating civilian massive trauma was not logistically feasible for this institution. Systematic identification of major obstacles to implementation suggested potential solutions for further trials these have been summarized in two manuscripts submitted for publication.

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Technical Report,01 Jun 2012,31 May 2016



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Approved For Public Release;

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