The current report was designed to test the consistency of
the findings of our previous reports on emergency tourniquet
use (3,4). The design was an observational study
of patient care; there was no experiment or intervention.
Before the study began we predetermined the data of
interest, that is, possible morbidity as well as the mortality
rates with the use of tourniquets. The study was
approved by our institutional review board as part of an
ongoing prospective performance improvement project
on tourniquet use (NCT00517166 at www.ClinicalTrials.
gov). The informed consent waiver was approved. Procedures
followed were in accord with the Helsinki Declaration
of 1975.