Pre-hospital Tourniquet in Extremity Injury

NCT ID: NCT04216225

Last Updated: 2024-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-11-01

Study Completion Date

2025-01-01

Brief Summary

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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

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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.

Conditions

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Extremity Injury

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

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pre-hospital tourniquet placement

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Methodist Health System

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael Truitt, M.D.

Role: PRINCIPAL_INVESTIGATOR

The Methodist Hospital Research Institute

Locations

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Methodist Dallas Medical Center

Dallas, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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098.GME.2017.D

Identifier Type: -

Identifier Source: org_study_id

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