Clinical Trial Summary
2.1. Objective:
• Primary Objective: To compare outcomes of patients with extremity injuries presenting with
or without pre-hospital tourniquet placement.
2.2. Study Outcome Measures
- Primary Outcome: Incidence of arrival in shock (SBP <90)
- Secondary Outcomes: Demographics, comorbidities, mechanism of injury, cause of injury,
diagnosis codes, procedure codes, Injury Severity Scale, Abbreviated Injury Scale,
operative management vs. non-operative management, radiologic findings, pathologic
findings, tourniquet effectiveness (as determined both subjectively by trauma surgeon
and objectively by presence vs. absence of pulse below level of tourniquet application),
total number of units of blood products transfused within first 24 hrs, total number of
units of blood products for index admission, type of blood products or other fluid
given, hospital length of stay, ICU length of stay, ventilator days, infectious
complications, other complications, discharge disposition, 24 hr mortality, overall
mortality.
This is a prospective, observational study. All patients who present to the participating
ED's who meet inclusion/exclusion criteria will be identified by the treating trauma
surgeons. Data collected will include basic patient demographics, data regarding the
patient's injuries, data regarding tourniquet use, and data regarding outcomes. Please see
the attached data collection tool for specifics (Appendix 12.1). Data will be collected
prospectively in an observational manner using the data collection tool. Data collected on
individual collection sheets will be de-identified. We plan to complete the data collection
and analysis by 01\01\2021.
