NCT04216225

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2018

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

December 30, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 2, 2020

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
Last Updated

November 20, 2024

Status Verified

September 1, 2024

Enrollment Period

6.2 years

First QC Date

December 30, 2019

Last Update Submit

November 18, 2024

Conditions

Extremity Injury

Outcome Measures

Primary Outcomes (1)

  • Incidence of arrival in shock

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

    First 24 hours .

Interventions

pre-hospital tourniquet placementOTHER

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients who present to the participating ED's who meet inclusion/exclusion criteria will be identified by the treating trauma surgeons.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Methodist Dallas Medical Center

Dallas, Texas, 75203, United States

Location

Study Officials

  • Michael Truitt, M.D.

    The Methodist Hospital Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 30, 2019

First Posted

January 2, 2020

Study Start

November 1, 2018

Primary Completion

January 1, 2025

Study Completion

January 1, 2025

Last Updated

November 20, 2024

Record last verified: 2024-09

Locations

US(1)