<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03762863</url>
  </required_header>
  <id_info>
    <org_study_id>QMREC2206a</org_study_id>
    <nct_id>NCT03762863</nct_id>
  </id_info>
  <brief_title>Retention of Tourniquet Application Skills Following Participation in a Bleeding Control Course</brief_title>
  <official_title>Retention of Tourniquet Application Skills Following Participation in a Bleeding Control Course</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Somerville Office of Emergency Management</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Somerville Office of Emergency Management</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Prospective, observational study of students 6 months after completing a Stop the Bleed&#xD;
      course to determine overall ability to effectively use a tourniquet to stop external&#xD;
      extremity hemorrhage. Following the release of the Hartford Consensus in October 2015, the&#xD;
      American College of Surgeons Committee on Trauma initiated the National Stop the Bleed&#xD;
      campaign (2) that among several proactive recommendations was to encourage first responders&#xD;
      and the lay public to become trained, equipped and empowered to step forward and intervene in&#xD;
      a bleeding emergency. The Stop the Bleed initiative provides baseline education and training&#xD;
      in the use of tourniquets to stop extremity hemorrhage when pressure alone does not work.&#xD;
      While the program has progressively provided education and training to over 130,000&#xD;
      individuals worldwide there are no recommendations regarding time intervals for refresher&#xD;
      training to maintain confidence and competence in the use of tourniquets. The rationale for&#xD;
      this study is to ascertain if tourniquet application skills are sufficiently maintained 6&#xD;
      months after participation in a Stop the Bleed course and to provide recommendations for&#xD;
      refresher training based on the results.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In response to an alarming rise in active shooter/hostile incidents in the United States, in&#xD;
      2013 the American College of Surgeons convened a committee of multidisciplinary trauma&#xD;
      experts who in collaboration with the federal government created a protocol for a national&#xD;
      policy to enhance survivability from these active shooter incidents as well as other&#xD;
      intentional mass casualty events. The committee's recommendations were called the Hartford&#xD;
      Consensus. Among the recommendations of the Hartford Consensus was the training of first&#xD;
      responders (law enforcement, EMS and fire personnel) as well as the public (so-called&#xD;
      &quot;immediate responders&quot;) in the basics of bleeding control. In October 2015, responding&#xD;
      aforementioned recommendation, the White House launched the Stop the Bleed national awareness&#xD;
      campaign as a &quot;call to action&quot;. Under the auspices of the American College of Surgeons&#xD;
      Committee on Trauma, a curriculum was developed teaching responders how to recognize and&#xD;
      intervene in the event of catastrophic bleeding. Of the three bleeding control interventions&#xD;
      promoted (external pressure, wound packing and tourniquet application) the tourniquet&#xD;
      application component of the Stop the Bleed curriculum is evidence-based and provides the&#xD;
      student with both didactic and psychomotor education. To date there is a paucity of data&#xD;
      available to provide insight as to how long this vital skill is retained. More over there is&#xD;
      no recommendation on refresher education with additional opportunities to practice this&#xD;
      life-saving procedure. This study will serve as a follow-up to Stop the Bleed (also called&#xD;
      Bleeding Control or B-Con) education provided by the investigator. The intent is to bring&#xD;
      participants from a Bleeding Control course back to the investigator 6 months following&#xD;
      initial education and assess their retention of tourniquet application skills. All&#xD;
      participants will be assessed using a tourniquet simulator and their success will be measured&#xD;
      in their ability to stop the bleeding using the simulator. The participants will be observed&#xD;
      for proper identification of bleeding necessitating the use of a tourniquet, selection of the&#xD;
      proper site of application, proper application of the device (use as described in the Stop&#xD;
      the Bleed curriculum). This study will not involve the use of actual patients or human&#xD;
      subjects. It is intended to be follow up assessment to skills-based education with an&#xD;
      endpoint that will provide insight as to a time-frame for refresher training. Of the three&#xD;
      bleeding control skills taught as part of the Stop the Bleed curriculum, the application the&#xD;
      tourniquet is a universal stop the bleed intervention and most likely intervention to be used&#xD;
      to stop the bleed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 1, 2018</start_date>
  <completion_date type="Actual">June 30, 2019</completion_date>
  <primary_completion_date type="Actual">June 30, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Tourniquet application retention</measure>
    <time_frame>6 months</time_frame>
    <description>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.&#xD;
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 (&quot;YES&quot; for correct, &quot;NO&quot; 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.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">46</enrollment>
  <condition>Hemorrhage</condition>
  <arm_group>
    <arm_group_label>Appropriate application of a CAT tourniquet</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Tourniquet application skill retention</intervention_name>
    <description>Tourniquet application following the procedure as learned in the Stop the Bleed curriculum.</description>
    <arm_group_label>Appropriate application of a CAT tourniquet</arm_group_label>
    <other_name>Evaluation of retention of critical steps in tourniquet application 6 months after attending a Stop the Bleed class.</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        All adults (18 years of age and above) participating in an American College of Surgeons&#xD;
        Sponsored &quot;Stop the Bleed&quot; course&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Less than 18 years of age&#xD;
&#xD;
          2. Any participant that attends another program that includes tourniquet application&#xD;
             skills after attendance at the Stop the Bleed program&#xD;
&#xD;
          3. Any participant that does not consent for inclusion for study data collection&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Somerville EMS Headquarters</name>
      <address>
        <city>Somerville</city>
        <state>New Jersey</state>
        <zip>08876</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>November 29, 2018</study_first_submitted>
  <study_first_submitted_qc>November 30, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 4, 2018</study_first_posted>
  <last_update_submitted>September 22, 2019</last_update_submitted>
  <last_update_submitted_qc>September 22, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 25, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hemorrhage</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>All raw data and methodology will be shared upon study completion</ipd_description>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>December 2019 through June 30 2019</ipd_time_frame>
    <ipd_access_criteria>email the investigator at sweinman@somervillenj.org</ipd_access_criteria>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03762863
org study id: QMREC2206a
nct id: NCT03762863
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
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.
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.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Tourniquet application retention
time frame: 6 months
description: 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.
arm group label: Appropriate application of a CAT tourniquet
arm group type: Experimental
description: 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.
intervention type: Device
intervention name: Tourniquet application skill retention
description: Tourniquet application following the procedure as learned in the Stop the Bleed curriculum.
arm group label: Appropriate application of a CAT tourniquet
other name: Evaluation of retention of critical steps in tourniquet application 6 months after attending a Stop the Bleed class.
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Sponsor
mesh term: Hemorrhage
sharing ipd: Yes
ipd description: All raw data and methodology will be shared upon study completion
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd time frame: December 2019 through June 30 2019
ipd access criteria: email the investigator at sweinman@somervillenj.org