<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/NCT04415606</url>
  </required_header>
  <id_info>
    <org_study_id>ZM-QCC-01</org_study_id>
    <nct_id>NCT04415606</nct_id>
  </id_info>
  <brief_title>QuikClot Control+ Hemostatic Dressing Use in Mild to Moderate Bleeding</brief_title>
  <official_title>A Pre-Market, Prospective, Controlled, Multicenter, Single Blinded, Pivotal Clinical Investigation of QuikClot Control+ for Use in Mild to Moderate Bleeding</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Z-Medica</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Z-Medica</source>
  <oversight_info>
    <has_dmc>Yes</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>
      QuikClot Control+ Hemostatic Dressing (QuikClot+) is indicated for temporary control of&#xD;
      internal organ space bleeding for patients displaying Class III or Class IV Bleeding. It may&#xD;
      also be used for control of severely bleeding wounds such as surgical wounds and traumatic&#xD;
      injuries. QuikClot Control+ is also indicated for temporary control of mild to moderate&#xD;
      bleeding in cardiac surgical procedures. QuikClot Control+ is also indicated for use to&#xD;
      control bleeding from bone surface following sternotomy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 11, 2020</start_date>
  <completion_date type="Actual">October 30, 2021</completion_date>
  <primary_completion_date type="Actual">October 30, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>Subject will not know which arm they were randomized to.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Achievement of hemostasis</measure>
    <time_frame>Up to 10 minutes</time_frame>
    <description>The primary effectiveness endpoint is the rate at which subjects achieve hemostasis (grade 0 bleed) through up to 10 minutes of application and compression of the bleeding site.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Achievement of hemostasis</measure>
    <time_frame>Up to 5 minute and 10 minutes</time_frame>
    <description>Proportion of subjects achieving hemostasis (grade 0 bleed) measured at 5 minute and 10 minutes of application and compression at the bleeding site.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">266</enrollment>
  <condition>Hemostasis</condition>
  <arm_group>
    <arm_group_label>QuikClot Control+</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>QuikClot Control+</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard gauze</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Standard gauze per standard of care</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>QuikClot Control+</intervention_name>
    <description>Non-absorbable, sterile, X-ray detectable non-woven dressing impregnated with kaolin.</description>
    <arm_group_label>QuikClot Control+</arm_group_label>
    <arm_group_label>Standard gauze</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age range greater than or equal to 18 years old&#xD;
&#xD;
          -  Willing and able to give prior written informed consent&#xD;
&#xD;
          -  Requiring cardiac surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject undergoing emergency surgery for any reason&#xD;
&#xD;
          -  Subject has active or potential infection at the surgical site or endocarditis&#xD;
&#xD;
          -  eGFR less that lo mL per minute&#xD;
&#xD;
          -  Subject who is currently participating in an investigational drug or another device&#xD;
             trial (excluding registries)&#xD;
&#xD;
          -  Leucopenia (WBC &lt; 3.5x 103/µL), or acute anemia (Hgb &lt; 10.0 mg/dL or 6 mmol/L), or&#xD;
             thrombocytopenia (platelet count &lt; 50x 103/µL), or history of bleeding diathesis or&#xD;
             coagulopathy, or HIT positive&#xD;
&#xD;
          -  Other medical, social, or psychological conditions that, in the opinion of the&#xD;
             Investigator, precludes the subject from appropriate consent or adherence to the&#xD;
             protocol required follow-up exams&#xD;
&#xD;
          -  Active illicit drug use, verbally confirmed with the patient&#xD;
&#xD;
          -  Severe Liver dysfunction confirmed via Child-Pugh of B-C or MELD &gt; 10&#xD;
&#xD;
          -  Female who is pregnant at screening. Confirmation by urine or serum pregnancy test&#xD;
&#xD;
          -  Incarcerated or unable to give voluntary informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mumashir Mumtaz, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>UPMC Pinnacle</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Colorado Health</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Emory</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30322</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Portneuf Medical Center / Snake River Research PLCC</name>
      <address>
        <city>Pocatello</city>
        <state>Idaho</state>
        <zip>83201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Washington University</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bryan Heart</name>
      <address>
        <city>Lincoln</city>
        <state>Nebraska</state>
        <zip>68506</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UPMC Pinnacle</name>
      <address>
        <city>Harrisburg</city>
        <state>Pennsylvania</state>
        <zip>17104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UPMC Pittsburgh</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15232</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>May 29, 2020</study_first_submitted>
  <study_first_submitted_qc>May 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>April 1, 2022</last_update_submitted>
  <last_update_submitted_qc>April 1, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 4, 2022</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>Undecided</sharing_ipd>
  </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/NCT04415606
org study id: ZM-QCC-01
nct id: NCT04415606
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
QuikClot Control+ Hemostatic Dressing (QuikClot+) is indicated for temporary control of
      internal organ space bleeding for patients displaying Class III or Class IV Bleeding. It may
      also be used for control of severely bleeding wounds such as surgical wounds and traumatic
      injuries. QuikClot Control+ is also indicated for temporary control of mild to moderate
      bleeding in cardiac surgical procedures. QuikClot Control+ is also indicated for use to
      control bleeding from bone surface following sternotomy.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
masking description: Subject will not know which arm they were randomized to.
measure: Achievement of hemostasis
time frame: Up to 10 minutes
description: The primary effectiveness endpoint is the rate at which subjects achieve hemostasis (grade 0 bleed) through up to 10 minutes of application and compression of the bleeding site.
measure: Achievement of hemostasis
time frame: Up to 5 minute and 10 minutes
description: Proportion of subjects achieving hemostasis (grade 0 bleed) measured at 5 minute and 10 minutes of application and compression at the bleeding site.
arm group label: QuikClot Control+
arm group type: Experimental
description: QuikClot Control+
arm group label: Standard gauze
arm group type: Placebo Comparator
description: Standard gauze per standard of care
intervention type: Device
intervention name: QuikClot Control+
description: Non-absorbable, sterile, X-ray detectable non-woven dressing impregnated with kaolin.
arm group label: QuikClot Control+
arm group label: Standard gauze
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Mumashir Mumtaz, MD
role: Principal Investigator
affiliation: UPMC Pinnacle
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Hemorrhage
sharing ipd: Undecided