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Pre-hospital Tourniquet in Extremity Injury

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04216225
Recruitment Status : Recruiting
First Posted : January 2, 2020
Last Update Posted : January 2, 2020
Sponsor:
Information provided by (Responsible Party):
Methodist Health System

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, ISS, AIS, 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.

Condition or disease Intervention/treatment
Extremity Injury Other: pre-hospital tourniquet placement

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.

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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Prospective Observational Multi-center Analysis of Pre-hospital Tourniquet in Extremity Injury
Actual Study Start Date : November 1, 2018
Estimated Primary Completion Date : January 1, 2021
Estimated Study Completion Date : January 1, 2021

Resource links provided by the National Library of Medicine



Intervention Details:
  • Other: pre-hospital tourniquet placement
    patients with extremity injuries presenting with or without pre-hospital tourniquet placement.


Primary Outcome Measures :
  1. Incidence of arrival in shock [ Time Frame: first 24 hrs. ]
    (Systolic Blood Pressure <90 mmHg)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04216225


Contacts
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Contact: Crystee Cooper, DHEd 214-947-1280 crsyteecooper@mhd.com
Contact: Nitasha Phatak, Ph.D. 214-947-4459 NitashaPhatak@mhd.com

Locations
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United States, Texas
Methodist Dallas Medical Center Recruiting
Dallas, Texas, United States, 75203
Contact: Michael Truitt, MD    214-947-2315    michaeltruitt@mhd.com   
Sponsors and Collaborators
Methodist Health System
Investigators
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Principal Investigator: Michael Truitt, M.D. Methodist Dallas Medical Center
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Responsible Party: Methodist Health System
ClinicalTrials.gov Identifier: NCT04216225    
Other Study ID Numbers: 098.GME.2017.D
First Posted: January 2, 2020    Key Record Dates
Last Update Posted: January 2, 2020
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Wounds and Injuries