HemorrhageNCT03762863
Retention of Tourniquet Application Skills Following Participation in a Bleeding Control Course
A study testing Tourniquet application skill retention in people with Hemorrhage, run by Somerville Office of Emergency Management at 1 site in United States.
Trial summary
Prospective, observational study of students 6 months after completing a Stop the Bleed course to determine overall ability to effectively use a tourniquet to stop external extremity hemorrhage. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hemorrhage
- What is being tested?
- Tourniquet application skill retention
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2018to 30 Jun 2019
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All adults (18 years of age and above) participating in an American College of Surgeons Sponsored "Stop the Bleed" course
Who cannot join
- Less than 18 years of age
- Any participant that attends another program that includes tourniquet application skills after attendance at the Stop the Bleed program
- Any participant that does not consent for inclusion for study data collection
Trial locations and contacts
1 site in 1 country.
United States1 site
Somerville EMS Headquarters
Somerville, New Jersey, 08876
About this study
Prospective, observational study of students 6 months after completing a Stop the Bleed course to determine overall ability to effectively use a tourniquet to stop external extremity hemorrhage. Following the release of the Hartford Consensus in October 2015, the American College of Surgeons Committee on Trauma initiated the National Stop the Bleed campaign (2) that among several proactive recommendations was to encourage first responders and the lay public to become trained, equipped and empowered to step forward and intervene in a bleeding emergency. The Stop the Bleed initiative provides baseline education and training in the use of tourniquets to stop extremity hemorrhage when pressure alone does not work. While the program has progressively provided education and training to over 130,000 individuals worldwide there are no recommendations regarding time intervals for refresher training to maintain confidence and competence in the use of tourniquets. The rationale for this study is to ascertain if tourniquet application skills are sufficiently maintained 6 months after participation in a Stop the Bleed course and to provide recommendations for refresher training based on the results.
Read the detailed description
In response to an alarming rise in active shooter/hostile incidents in the United States, in 2013 the American College of Surgeons convened a committee of multidisciplinary trauma experts who in collaboration with the federal government created a protocol for a national policy to enhance survivability from these active shooter incidents as well as other intentional mass casualty events. The committee's recommendations were called the Hartford Consensus. Among the recommendations of the Hartford Consensus was the training of first responders (law enforcement, EMS and fire personnel) as well as the public (so-called "immediate responders") in the basics of bleeding control. In October 2015, responding aforementioned recommendation, the White House launched the Stop the Bleed national awareness campaign as a "call to action". Under the auspices of the American College of Surgeons Committee on Trauma, a curriculum was developed teaching responders how to recognize and intervene in the event of catastrophic bleeding. Of the three bleeding control interventions promoted (external pressure, wound packing and tourniquet application) the tourniquet application component of the Stop the Bleed curriculum is evidence-based and provides the student with both didactic and psychomotor education. To date there is a paucity of data available to provide insight as to how long this vital skill is retained. More over there is no recommendation on refresher education with additional opportunities to practice this life-saving procedure. This study will serve as a follow-up to Stop the Bleed (also called Bleeding Control or B-Con) education provided by the investigator. The intent is to bring participants from a Bleeding Control course back to the investigator 6 months following initial education and assess their retention of tourniquet application skills. All participants will be assessed using a tourniquet simulator and their success will be measured in their ability to stop the bleeding using the simulator. The participants will be observed for proper identification of bleeding necessitating the use of a tourniquet, selection of the proper site of application, proper application of the device (use as described in the Stop the Bleed curriculum). This study will not involve the use of actual patients or human subjects. It is intended to be follow up assessment to skills-based education with an endpoint that will provide insight as to a time-frame for refresher training. Of the three bleeding control skills taught as part of the Stop the Bleed curriculum, the application the tourniquet is a universal stop the bleed intervention and most likely intervention to be used to stop the bleed.
- Conditions
- Hemorrhage
- Being tested
- Tourniquet application skill retention
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tourniquet application skill retentionDevice
Also called Evaluation of retention of critical steps in tourniquet application 6 months after attending a Stop the Bleed class.
Tourniquet application following the procedure as learned in the Stop the Bleed curriculum.
| Study group | Role | What they receive |
|---|---|---|
| Appropriate application of a CAT tourniquet | Experimental | All study subjects attended an American College of Surgeons Stop the Bleed Basic course with live training by approved instructors. 6 months after participation in the Stop the Bleed class volunteers study subjects are randomly solicited to return for a refresher session. During this refresher session the volunteer study subjects are observed to determine if they have retained tourniquet application skills and to what degree they have retained them. A 10 point check list will be used to evaluated tourniquet application skill retention. Receives: Device: Tourniquet application skill retention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tourniquet application retention
A 10 point data collection checklist was developed paralleling the procedure for tourniquet application as set forth in the American College of Surgeons Committee on Trauma's Stop the Bleed curriculum. Each participant number will be assigned to each volunteer to maintain anonymity and for accounting purposes.
Each participant will be isolated and observed by the investigator as he/she attempts to apply a tourniquet to a simulated leg amputation simulator (BCon Trainer, Techline Technologies, Willow Grove, PA). As the participant proceeds with the application of the tourniquet the observer will compare the steps in the tourniquet application process with the steps on data collection form noting any deviations ("YES" for correct, "NO" for deviation or failure to follow that step). Also noted will be total time to complete the tourniquet application process. The raw data from each form will be transferred to a master spread sheet for ease of data analysis.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2018
- Study start1 Nov 2018
- Primary completion30 Jun 2019
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemorrhageStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Somerville Office of Emergency Management
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03762863
- Sponsor's protocol ID
- QMREC2206a
- Status last verified
- Sep 2019
- First submitted
- 29 Nov 2018
- Last updated
- 25 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: All raw data and methodology will be shared upon study completion
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retention of Tourniquet Application Skills Following Participation in a Bleeding Control Course
- ClinicalTrials.gov ID
- NCT03762863
- Acronym / sponsor ID
- QMREC2206a
- Conditions
- Hemorrhage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Somerville Office of Emergency ManagementUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 4 Dec 2018 (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.
Prospective, observational study of students 6 months after completing a Stop the Bleed course to determine overall ability to effectively use a tourniquet to stop external extremity hemorrhage. Following the release of the Hartford Consensus in October 2015, the American College of Surgeons Committee on Trauma initiated the National Stop the Bleed campaign (2) that among several proactive recommendations was to encourage first responders and the lay public to become trained, equipped and empowered to step forward and intervene in a bleeding emergency. The Stop the Bleed initiative provides baseline education and training in the use of tourniquets to stop extremity hemorrhage when pressure alone does not work. While the program has progressively provided education and training to over 130,000 individuals worldwide there are no recommendations regarding time intervals for refresher training to maintain confidence and competence in the use of tourniquets. The rationale for this study is to ascertain if tourniquet application skills are sufficiently maintained 6 months after participation in a Stop the Bleed course and to provide recommendations for refresher training based on the results.
Detailed description
In response to an alarming rise in active shooter/hostile incidents in the United States, in 2013 the American College of Surgeons convened a committee of multidisciplinary trauma experts who in collaboration with the federal government created a protocol for a national policy to enhance survivability from these active shooter incidents as well as other intentional mass casualty events. The committee's recommendations were called the Hartford Consensus. Among the recommendations of the Hartford Consensus was the training of first responders (law enforcement, EMS and fire personnel) as well as the public (so-called "immediate responders") in the basics of bleeding control. In October 2015, responding aforementioned recommendation, the White House launched the Stop the Bleed national awareness campaign as a "call to action". Under the auspices of the American College of Surgeons Committee on Trauma, a curriculum was developed teaching responders how to recognize and intervene in the event of catastrophic bleeding. Of the three bleeding control interventions promoted (external pressure, wound packing and tourniquet application) the tourniquet application component of the Stop the Bleed curriculum is evidence-based and provides the student with both didactic and psychomotor education. To date there is a paucity of data available to provide insight as to how long this vital skill is retained. More over there is no recommendation on refresher education with additional opportunities to practice this life-saving procedure. This study will serve as a follow-up to Stop the Bleed (also called Bleeding Control or B-Con) education provided by the investigator. The intent is to bring participants from a Bleeding Control course back to the investigator 6 months following initial education and assess their retention of tourniquet application skills. All participants will be assessed using a tourniquet simulator and their success will be measured in their ability to stop the bleeding using the simulator. The participants will be observed for proper identification of bleeding necessitating the use of a tourniquet, selection of the proper site of application, proper application of the device (use as described in the Stop the Bleed curriculum). This study will not involve the use of actual patients or human subjects. It is intended to be follow up assessment to skills-based education with an endpoint that will provide insight as to a time-frame for refresher training. Of the three bleeding control skills taught as part of the Stop the Bleed curriculum, the application the tourniquet is a universal stop the bleed intervention and most likely intervention to be used to stop the bleed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Appropriate application of a CAT tourniquet | Experimental | Device: Tourniquet application skill retentionAll study subjects attended an American College of Surgeons Stop the Bleed Basic course with live training by approved instructors. 6 months after participation in the Stop the Bleed class volunteers study subjects are randomly solicited to return for a refresher session. During this refresher session the volunteer study subjects are observed to determine if they have retained tourniquet application skills and to what degree they have retained them. A 10 point check list will be used to evaluated tourniquet application skill retention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All adults (18 years of age and above) participating in an American College of Surgeons Sponsored "Stop the Bleed" course
Key exclusion criteria (3 listed)
- Less than 18 years of age
- Any participant that attends another program that includes tourniquet application skills after attendance at the Stop the Bleed program
- Any participant that does not consent for inclusion for study data collection
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 |
|---|---|---|
| Tourniquet application skill retentionAlso: Evaluation of retention of critical steps in tourniquet application 6 months after attending a Stop the Bleed class.Tourniquet application following the procedure as learned in the Stop the Bleed curriculum. | Device | Appropriate application of a CAT tourniquet |
Primary outcome
Tourniquet application retention
Time frame: 6 months
A 10 point data collection checklist was developed paralleling the procedure for tourniquet application as set forth in the American College of Surgeons Committee on Trauma's Stop the Bleed curriculum. Each participant number will be assigned to each volunteer to maintain anonymity and for accounting purposes. Each participant will be isolated and observed by the investigator as he/she attempts to apply a tourniquet to a simulated leg amputation simulator (BCon Trainer, Techline Technologies, Willow Grove, PA). As the participant proceeds with the application of the tourniquet the observer will compare the steps in the tourniquet application process with the steps on data collection form noting any deviations ("YES" for correct, "NO" for deviation or failure to follow that step). Also noted will be total time to complete the tourniquet application process. The raw data from each form will be transferred to a master spread sheet for ease of data analysis.
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 25 Sep 2019.
- Individual participant dataSharing planned: Yes. All raw data and methodology will be shared upon study completion
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tourniquet application skill retention in people with Hemorrhage, run by Somerville Office of Emergency Management 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 1 inclusion and 3 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 25 Sep 2019. 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?
Tourniquet application retention (time frame: 6 months). 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 25 Sep 2019; AzTrials last refreshed its copy on 8 Nov 2026.