Methodology of the Field Administration of Stroke Therapy - Magnesium (FAST-MAG) phase 3 trial: Part 2 - prehospital study methods.

ABSTRACT:

Rationale

In acute stroke, the volume of salvageable brain tissue is maximal at onset and declines rapidly with time. Prehospital start of clinical trial interventions would enable delivery of neuroprotective agents, such as magnesium sulfate, to stroke patients in the hyperacute period when they are potentially most effective.

Aims

A broad aim of the FAST-MAG study is to develop and validate techniques to perform pivotal trials of neuroprotective therapies for acute stroke in the prehospital setting. In tandem with an accompanying general trial design article, this manuscript provides a detailed overview of several novel prehospital study methods employed in the NIH FAST-MAG Trial.

Design

Multicenter, randomized, double-blinded, placebo-controlled, pivotal clinical t

SUBMITTER: Saver JL 

PROVIDER: S-EPMC4909491 | biostudies-literature | 2014 Feb

REPOSITORIES: biostudies-literature