Traumatic Hemorrhage Clinical Trial
— PATTSOfficial title:
Determine the Most Effective Intervention for Hemorrhage Control Readiness for Laypersons
Verified date | March 2018 |
Source | Brigham and Women's Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a randomized controlled study evaluating the ability of laypersons to correctly apply a tourniquet using different instructional methods. There are four arms being evaluated: flashcards, audio-kit with visual aids, formal in person Bleeding Control Basic (B-Con) course, and a control arm. All participants will then undergo B-Con training at the end of each session and then participants will be evaluated within a 3-6 month time period to evaluate their retention of knowledge and skills taught by the B-Con course.
Status | Completed |
Enrollment | 562 |
Est. completion date | January 30, 2018 |
Est. primary completion date | January 30, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - employees of Gillette Stadium >18 years old Exclusion Criteria: - participants who self-report prior hemorrhage control training will be excluded from the final analysis for tourniquet application but included in randomization |
Country | Name | City | State |
---|---|---|---|
United States | Brigham and Women's Hospital | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Brigham and Women's Hospital | Gillette Stadium, The Gillian Reny Stepping Strong Center for Trauma Innovation |
United States,
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Goolsby C, Branting A, Chen E, Mack E, Olsen C. Just-in-Time to Save Lives: A Pilot Study of Layperson Tourniquet Application. Acad Emerg Med. 2015 Sep;22(9):1113-7. doi: 10.1111/acem.12742. Epub 2015 Aug 20. — View Citation
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Correct application of tourniquet at initial training and retention training | Correct Tourniquet Application ( Yes/No) is comprised of 3 measures (participants must succeed at All 3 Elements: Length of Time, Tension, Location must be correct for appropriate tourniquet application) 1. Timing (Minutes and Seconds) 2. Tension (Tightness) of Tourniquet (Yes or No, is determined by attempting to forcefully slide a Kelly clamp under between the tourniquet and the extremity of the mannequin) 3. Location of Tourniquet ( Measurement in Inches from wound site ) | 4 hours and 6 Months Average | |
Secondary | Time to tourniquet application | Minutes and Seconds | 4 hours | |
Secondary | Layperson Empowerment before and after B-Con training | Evaluation of layperson self-reported empowerment before and after B-Con training assessing parameters such as their willingness to assist in an emergency and their comfort level controlling hemorrhage using a Likert Scale (1-5). | Change over time immediately after training and 3-9 months later | |
Secondary | Reasons for incorrect tourniquet application | The criteria for incorrect tourniquet application include inadequate tightness, not incorrect anatomical placement, and greater than 7 minutes needed to place the tourniquet which will be assessed. | immediately and 3-9 months after intial training (retention testing) |
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