Accounting for repeat enrollments during an emergency clinical trial: the Rapid Anticonvulsant Medications Prior to Arrival Trial (RAMPART).

ABSTRACT:

Objectives

The objectives were to describe the frequency of repeat enrollment within a specific exception from informed consent trial testing benzodiazepine treatment of prehospital status epilepticus and to estimate the effect of repeat enrollments on the analysis of the primary outcome.

Methods

This was a secondary analysis of data collected as part of the Rapid Anticonvulsant Medication Prior to Arrival Trial (RAMPART), a study comparing intramuscular midazolam to intravenous lorazepam given by paramedics to patients with prehospital status epilepticus. Subjects in RAMPART achieved a successful primary outcome if they had cessation of seizures by the time of emergency department arrival. Data were collected on all subjects, but only the first enrollment for each individua

SUBMITTER: Meurer WJ 

PROVIDER: S-EPMC4363089 | biostudies-literature | 2015 Mar

REPOSITORIES: biostudies-literature