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Pre-hospital Tourniquet in Extremity Injury

Prospective Observational Multi-center Analysis of Pre-hospital Tourniquet in Extremity Injury

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04216225
Enrollment
55
Registered
2020-01-02
Start date
2018-11-01
Completion date
2021-12-13
Last updated
2026-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Extremity Injury

Brief 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.

Detailed description

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.

Interventions

OTHERpre-hospital tourniquet placement

patients with extremity injuries presenting with or without pre-hospital tourniquet placement.

Sponsors

Methodist Health System
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

Inclusion criteria

≥ 18 y/o Patients with extremity injuries * With a tourniquet in place OR * Who the treating physician deems could have benefited from tourniquet placement

Exclusion criteria

* Children * Prisoners * Pregnant women * Patients with non-traumatic bleeding requiring tourniquet use

Design outcomes

Primary

MeasureTime frameDescription
Incidence of arrival in shockFirst 24 hours .(Systolic Blood Pressure \<90 mmHg (Millimeter of mercury))

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORMichael Truitt, M.D.

The Methodist Hospital Research Institute

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 12, 2026