<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/NCT03765866</url>
  </required_header>
  <id_info>
    <org_study_id>022015-093</org_study_id>
    <nct_id>NCT03765866</nct_id>
  </id_info>
  <brief_title>Rotational Thromboelastometry Activated Transfusion In Trauma Trial</brief_title>
  <acronym>ROTATE-IT</acronym>
  <official_title>Viscoelastic Guided Goal Directed Resuscitation of Severely Injured Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Texas Southwestern Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Texas Southwestern Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a randomized controlled trial to compare viscoelastic (VE) guided resuscitation to&#xD;
      fixed-ratio resuscitation in trauma patients with hemorrhagic shock on the utilization of&#xD;
      blood products, effects on coagulation and inflammatory mediators, and how these strategies&#xD;
      affect post resuscitation adverse events.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is an open labeled study as the VE guided resuscitation will be based on the visible VE&#xD;
      results. Aim 1 will compare the number of blood products utilized in each resuscitation&#xD;
      strategy. Aim 2 will analyze the coagulation and inflammatory mediators in each resuscitation&#xD;
      strategy to determine if there is a difference in the mechanism of coagulopathy. Aim 3 will&#xD;
      determine if the different resuscitation strategies have an effect on post resuscitation&#xD;
      adverse events.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2016</start_date>
  <completion_date type="Actual">December 17, 2018</completion_date>
  <primary_completion_date type="Actual">December 17, 2018</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in number of blood products utilized at 24 hours</measure>
    <time_frame>24 hours from time of randomization</time_frame>
    <description>Number of blood products utilized during that time frame will be recorded to determine if change in resuscitation strategies result in measurable differences</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in coagulation profile</measure>
    <time_frame>0 hours and 30 days</time_frame>
    <description>Analyze coagulation profiles in each resuscitation strategy to determine if there is a change in the mechanism of coagulopathy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in inflammatory mediators</measure>
    <time_frame>0 hours and 30 days</time_frame>
    <description>Analyze inflammatory mediators in each resuscitation strategy to determine if there is a change in the mechanism of coagulopathy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Resuscitation strategy-related adverse events</measure>
    <time_frame>30 days after admission</time_frame>
    <description>Rate of resuscitation strategies-related adverse events as a composite, including (transfusion related acute lung injury, transfusion associated circulatory overload, hyperkalemia, hypocalcemia, allergic reaction, hemolysis and transfusion transmitted infection)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">31</enrollment>
  <condition>Trauma</condition>
  <arm_group>
    <arm_group_label>Massive Transfusion Protocol Guided</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Clinicians will only transfuse patients according to standard massive transfusion protocol (MTP)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Thromboelastometry guided transfusion</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Clinicians will transfuse patients according to ROTEM results.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Thromboelastometry guided transfusion</intervention_name>
    <description>Comparing resuscitation strategies with standard MTP v.s. ROTEM guided MTP</description>
    <arm_group_label>Thromboelastometry guided transfusion</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Trauma patient&#xD;
&#xD;
          2. MTP Activation&#xD;
&#xD;
          3. Only patients ≥ 14 years old&#xD;
&#xD;
          4. Alive at 31 mins after arrival in ED&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Transfer from OSH&#xD;
&#xD;
          2. Received CPR for more than 5 mins&#xD;
&#xD;
          3. Burned&#xD;
&#xD;
          4. Pregnant or Prisoner&#xD;
&#xD;
          5. Known DNR&#xD;
&#xD;
          6. Jehovah's witness&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>14 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michael W. Cripps, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>UT Southwestern Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Parkland Memorial Hospital</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75206</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Schlimp CJ, Voelckel W, Inaba K, Maegele M, Schochl H. Impact of fibrinogen concentrate alone or with prothrombin complex concentrate (+/- fresh frozen plasma) on plasma fibrinogen level and fibrin-based clot strength (FIBTEM) in major trauma: a retrospective study. Scand J Trauma Resusc Emerg Med. 2013 Oct 8;21:74. doi: 10.1186/1757-7241-21-74.</citation>
    <PMID>24103457</PMID>
  </reference>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 23, 2016</study_first_submitted>
  <study_first_submitted_qc>December 3, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 5, 2018</study_first_posted>
  <last_update_submitted>May 27, 2020</last_update_submitted>
  <last_update_submitted_qc>May 27, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 29, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>rotational thromboelastometry</keyword>
  <keyword>viscoelastic test</keyword>
  <keyword>coagulopathy</keyword>
  <keyword>trauma</keyword>
  <keyword>hemorrhage</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Wounds and Injuries</mesh_term>
  </condition_browse>
  <!-- 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/NCT03765866
org study id: 022015-093
nct id: NCT03765866
lead sponsor: 
has dmc: Yes
This is a randomized controlled trial to compare viscoelastic (VE) guided resuscitation to
      fixed-ratio resuscitation in trauma patients with hemorrhagic shock on the utilization of
      blood products, effects on coagulation and inflammatory mediators, and how these strategies
      affect post resuscitation adverse events.
This is an open labeled study as the VE guided resuscitation will be based on the visible VE
      results. Aim 1 will compare the number of blood products utilized in each resuscitation
      strategy. Aim 2 will analyze the coagulation and inflammatory mediators in each resuscitation
      strategy to determine if there is a difference in the mechanism of coagulopathy. Aim 3 will
      determine if the different resuscitation strategies have an effect on post resuscitation
      adverse events.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in number of blood products utilized at 24 hours
time frame: 24 hours from time of randomization
description: Number of blood products utilized during that time frame will be recorded to determine if change in resuscitation strategies result in measurable differences
measure: Change in coagulation profile
time frame: 0 hours and 30 days
description: Analyze coagulation profiles in each resuscitation strategy to determine if there is a change in the mechanism of coagulopathy
measure: Change in inflammatory mediators
time frame: 0 hours and 30 days
description: Analyze inflammatory mediators in each resuscitation strategy to determine if there is a change in the mechanism of coagulopathy
measure: Changes in Resuscitation strategy-related adverse events
time frame: 30 days after admission
description: Rate of resuscitation strategies-related adverse events as a composite, including (transfusion related acute lung injury, transfusion associated circulatory overload, hyperkalemia, hypocalcemia, allergic reaction, hemolysis and transfusion transmitted infection)
arm group label: Massive Transfusion Protocol Guided
arm group type: No Intervention
description: Clinicians will only transfuse patients according to standard massive transfusion protocol (MTP)
arm group label: Thromboelastometry guided transfusion
arm group type: Experimental
description: Clinicians will transfuse patients according to ROTEM results.
intervention type: Procedure
intervention name: Thromboelastometry guided transfusion
description: Comparing resuscitation strategies with standard MTP v.s. ROTEM guided MTP
arm group label: Thromboelastometry guided transfusion
criteria: 
gender: All
minimum age: 14 Years
maximum age: 100 Years
healthy volunteers: No
last name: Michael W. Cripps, M.D.
role: Principal Investigator
affiliation: UT Southwestern Medical Center
facility: 
country: United States
citation: Schlimp CJ, Voelckel W, Inaba K, Maegele M, Schochl H. Impact of fibrinogen concentrate alone or with prothrombin complex concentrate (+/- fresh frozen plasma) on plasma fibrinogen level and fibrin-based clot strength (FIBTEM) in major trauma: a retrospective study. Scand J Trauma Resusc Emerg Med. 2013 Oct 8;21:74. doi: 10.1186/1757-7241-21-74.
PMID: 24103457
responsible party type: Sponsor
mesh term: Wounds and Injuries