Pre-hospital Tourniquet in Extremity Injury

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.

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Key information

Conditions

Extremity Injury

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Methodist Dallas Medical Center

Dallas, Texas, 75203, United States

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

pre-hospital tourniquet placement

Other

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

Primary outcomes

Incidence of arrival in shock

Time frame: First 24 hours .

(Systolic Blood Pressure <90 mmHg (Millimeter of mercury))

Sponsors and collaborators

Lead sponsor

Methodist Health System

Other

Registry information

Official study title

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

Important dates

Study start: 2018
Primary completion: 2021
Study completion: 2021
First posted: Jan 2, 2020
Registry last updated: Jun 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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