Extremity InjuryNCT04216225
Pre-hospital Tourniquet in Extremity Injury
An observational study of Extremity Injury, run by Methodist Health System at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Extremity Injury
- What is being tested?
- pre-hospital tourniquet placement
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2018to 13 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: All patients who present to the participating ED's who meet inclusion/exclusion criteria will be identified by the treating trauma surgeons.
Who may be able to join
- ≥ 18 y/o Patients with extremity injuries
- With a tourniquet in place OR
- Who the treating physician deems could have benefited from tourniquet placement
Who cannot join
- Children
- Prisoners
- Pregnant women
- Patients with non-traumatic bleeding requiring tourniquet use
Trial locations and contacts
1 site in 1 country.
United States1 site
Methodist Dallas Medical Center
Dallas, Texas, 75203
About this study
Official title: Prospective Observational Multi-center Analysis of 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.
Read more
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.
Read the 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.
- Conditions
- Extremity Injury
- Being tested
- pre-hospital tourniquet placement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pre-hospital tourniquet placementOther
patients with extremity injuries presenting with or without pre-hospital tourniquet placement.
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of arrival in shock
(Systolic Blood Pressure <90 mmHg (Millimeter of mercury))
Measured: First 24 hours .
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2020
- Study start1 Nov 2018
- Primary completion13 Dec 2021
- Study completion13 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extremity InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Methodist Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Truitt, M.D., Principal investigator, The Methodist Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04216225
- Sponsor's protocol ID
- 098.GME.2017.D
- Status last verified
- Sep 2024
- First submitted
- 30 Dec 2019
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Multi-center Analysis of Pre-hospital Tourniquet in Extremity Injury
- ClinicalTrials.gov ID
- NCT04216225
- Acronym / sponsor ID
- 098.GME.2017.D
- Conditions
- Extremity Injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Methodist Health SystemUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 13 Dec 2021 (actual)
- Study completion
- 13 Dec 2021 (actual)
- First posted
- 2 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All patients who present to the participating ED's who meet inclusion/exclusion criteria will be identified by the treating trauma surgeons.
Key inclusion criteria (3 listed)
- ≥ 18 y/o Patients with extremity injuries
- With a tourniquet in place OR
- Who the treating physician deems could have benefited from tourniquet placement
Key exclusion criteria (4 listed)
- Children
- Prisoners
- Pregnant women
- Patients with non-traumatic bleeding requiring tourniquet use
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pre-hospital tourniquet placementpatients with extremity injuries presenting with or without pre-hospital tourniquet placement. | Other | – |
Primary outcome
Incidence of arrival in shock
Time frame: First 24 hours .
(Systolic Blood Pressure <90 mmHg (Millimeter of mercury))
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Extremity Injury
Not yet recruiting
Accessible Remote Rehabilitation System for Real-Time Biomechanical Monitoring
Hand Injury Rehabilitation, Postoperative Rehabilitation
Not yet recruiting
Stair Biomechanics and Vibration Study After ACLR
Anterior Cruciate Ligament Reconstruction (ACLR), Anterior Cruciate Ligament Injury
Not yet recruiting
Influence of Transcranial Electrical Stimulation on Arm and Hand Function After Cervical Spinal Cord Injury
Spinal Cord Injury
RecruitingPhase 4
Individualised Cryoneurolysis to Treat Pain in the Context of Spasticity in the Upper and Lower Extremities
Centreal Neurological Condition, Acquired Brain Injury (Including Stroke)
Recruiting
Investigating Auto Adjusting Dynamic AFO
Lower Limb; Fusion, Congenital, Lower Limb Fracture
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Truitt, M.D. principal investigator
The Methodist Hospital Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Extremity Injury, run by Methodist Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of arrival in shock (time frame: First 24 hours .). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2026.