<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/NCT03780894</url>
  </required_header>
  <id_info>
    <org_study_id>PRETIC</org_study_id>
    <nct_id>NCT03780894</nct_id>
  </id_info>
  <brief_title>Transfusion of Red Blood Cells, Tranexamic Acid and Fibrinogen Concentrate for Severe Trauma Hemorrhage at Pre-hospital Phase of Care.</brief_title>
  <acronym>PRETIC</acronym>
  <official_title>Transfusion of Red Blood Cells (RBC), Tranexamic Acid (TXA) and Fibrinogen Concentrate (FC) for Severe Trauma Hemorrhage at Pre-hospital Phase of Care. A Pilot Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Banc de Sang i Teixits</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Sistema d'Emergències Mèdiques (SEM)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>IDIBGI (Institut d'Investigació Biomèdica de Girona Dr. Trueta)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Banc de Sang i Teixits</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a single-center, not-randomized, open-label, controlled pilot clinical trial. This&#xD;
      study compares presence of Trauma Induced Coagulopathy (TIC) and acute traumatic hemorrhage&#xD;
      treatment at pre-hospital phase of care with red blood cells (RBC), Tranexamic acid (TXA) and&#xD;
      Fibrinogen Concentrate (FC) with the current treatment based on the administration of&#xD;
      Crystalloids and TXA.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A pilot, non-randomized, open-label study of two intervention arms and controlled with the&#xD;
      standard treatment in which 60 patients affected with acute hemorrhage due to severe trauma&#xD;
      will enter the study with the main objective of evaluating the feasibility and the efficacy&#xD;
      of early treatment during the pre-hospital care phase with packed red blood cells, fibrinogen&#xD;
      concentrate and tranexamic acid (experimental arm) compared to the standard treatment based&#xD;
      on crystalloids administration and tranexamic acid (control arm). The secondary objectives&#xD;
      are to evaluate the safety and clinical evolution of the patients. Prior to the&#xD;
      administration of the treatment, 2 blood samples will be extracted in both groups in order to&#xD;
      compare the coagulation status and to be able to perform the pre-transfusion tests. On&#xD;
      arrival at the hospital, another sample will be taken to compare changes in coagulation after&#xD;
      the administration of the experimental or standard treatment and also between both groups.&#xD;
      The assessment of the coagulation status will be made using the values provided by the&#xD;
      viscoelastic test (TEG6s). The experimental and standard treatment will be administered&#xD;
      endovenously. After treatment, patients will be evaluated up to 30 days.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">November 21, 2018</start_date>
  <completion_date type="Anticipated">October 30, 2023</completion_date>
  <primary_completion_date type="Actual">January 11, 2021</primary_completion_date>
  <phase>Phase 1/Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Single-center, non-randomized, open-label, two-arms, controlled pilot clinical trial.&#xD;
The experimental and control arms will be determined according to the SEM units with RBC, TXA and FC administration capacity (i.e. helicopter unit, rapid intervention ambulance or advanced life support ambulance). The emergency SEM units are activated according current protocols based on distance, severity and weather conditions.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>TEG6s(R) parameters for Trauma Induced Coagulopathy (TIC)</measure>
    <time_frame>Basal (at the crash site)</time_frame>
    <description>TEG6s(R) parameters that define TIC</description>
  </primary_outcome>
  <primary_outcome>
    <measure>TEG6s(R) parameters for Trauma Induced Coagulopathy (TIC)</measure>
    <time_frame>Basal (at the hospital arrival)</time_frame>
    <description>TEG6s(R) parameters that define TIC</description>
  </primary_outcome>
  <primary_outcome>
    <measure>All-cause mortality</measure>
    <time_frame>1 hour post hospital admission</time_frame>
    <description>Mortality for any cause</description>
  </primary_outcome>
  <primary_outcome>
    <measure>All-cause mortality</measure>
    <time_frame>6 hours post hospital admission</time_frame>
    <description>Mortality for any cause</description>
  </primary_outcome>
  <primary_outcome>
    <measure>All-cause mortality</measure>
    <time_frame>24 hours post hospital admission</time_frame>
    <description>Mortality for any cause</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Accountability</measure>
    <time_frame>30 days</time_frame>
    <description>Red bood cells concentrate accountability</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Temperature storage conditions of the red blood cells concentrate</measure>
    <time_frame>24 hours</time_frame>
    <description>Red bood cells concentrate out of temperature range for storage</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>All-cause mortality</measure>
    <time_frame>48 hours post hospital admission</time_frame>
    <description>Mortality for any cause</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>All-cause mortality</measure>
    <time_frame>30 days post hospital admission</time_frame>
    <description>Mortality for any cause</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse Events</measure>
    <time_frame>30 days post hospital admission (or previously at hospital discharge)</time_frame>
    <description>Treatment emergent adverse events</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Thromboembolism events</measure>
    <time_frame>30 days</time_frame>
    <description>Thromboembolism events</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Crystalloid fluid requirements</measure>
    <time_frame>1 hour (from the crash site to the hospital admission)</time_frame>
    <description>Volume of crystalloids required</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Crystalloid fluid requirements</measure>
    <time_frame>30 days post hospital admission (or previously at hospital discharge)</time_frame>
    <description>Volume of crystalloids required</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Transfusion requirements</measure>
    <time_frame>24 hours (or previously at discharge of the emergency room)</time_frame>
    <description>Transfusion requirements of RBC, platelets and plasma</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Transfusion requirements</measure>
    <time_frame>30 days post hospital admission (or previously at hospital discharge)</time_frame>
    <description>Transfusion requirements of RBC, platelets and plasma</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Water balance</measure>
    <time_frame>24 hours of admission at the ICU</time_frame>
    <description>Water balance at the Intensive Care Unit (ICU)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Water balance</measure>
    <time_frame>72 hours of admission at the ICU</time_frame>
    <description>Water balance at the Intensive Care Unit (ICU)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ventilator-free days</measure>
    <time_frame>30 days</time_frame>
    <description>Ventilator-free days at the ICU</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Polytrauma</condition>
  <condition>Traumatic Hemorrhage</condition>
  <arm_group>
    <arm_group_label>Experimental treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The active treatment consists of intravenous injection of 2g of fibrinogen concentrate, 1g of tranexamic acid, 2 red bood cells concentrate O Rh(D) negative (Banc de Sang i Teixits, Barcelona, Spain), and crystalloids at pre-hospital phase of care.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard treatment</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients in the control arm will be treated according the existing protocols based on crystalloids and tranexamic acid administration.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fibrinogen Concentrate (Human) 1 MG [RiaSTAP]</intervention_name>
    <description>Administration of 2 mg of FC together with RBC and TXA</description>
    <arm_group_label>Experimental treatment</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Red blood cells concentrate</intervention_name>
    <description>Administration of 2 red blood cells concentrates together with FC and TXA</description>
    <arm_group_label>Experimental treatment</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tranexamic Acid</intervention_name>
    <description>Administration of 1g of TXA together with FC and RBC</description>
    <arm_group_label>Experimental treatment</arm_group_label>
    <arm_group_label>Standard treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥18 years AND&#xD;
&#xD;
          -  Patients with severe trauma categorized as priority 0 or 1 according to the CatSalut&#xD;
             Polytrauma Code (PPT) AND&#xD;
&#xD;
          -  Evidence of bleeding or a high bleeding suspicion according to physician judgment OR&#xD;
&#xD;
          -  Predicted to need transfusion according to TICCS score ≥10&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Moribund patient with devastating injuries and expected to die within 1-hour OR&#xD;
&#xD;
          -  Known objection to blood components transfusion OR&#xD;
&#xD;
          -  Known acquired or congenital coagulopathies not related to the actual trauma OR&#xD;
&#xD;
          -  Known anticoagulant treatment (vitamin K antagonist, dabigatran, rivaroxaban,&#xD;
             apixaban) OR&#xD;
&#xD;
          -  Known Pregnancy OR&#xD;
&#xD;
          -  Severe isolated traumatic brain injury OR&#xD;
&#xD;
          -  Hemorrhage not related to the actual trauma&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Hospital Josep Trueta</name>
      <address>
        <city>Girona</city>
        <zip>17007</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <link>
    <url>http://www.bancsang.net</url>
    <description>Blood and Tissue Bank of Catalonia</description>
  </link>
  <link>
    <url>http://icsgirona.cat</url>
    <description>HOspital Universitari Dr. Trueta (Girona, Spain)</description>
  </link>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>December 12, 2018</study_first_submitted>
  <study_first_submitted_qc>December 17, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <last_update_submitted>July 14, 2023</last_update_submitted>
  <last_update_submitted_qc>July 14, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 17, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Polytrauma</keyword>
  <keyword>Red blood cells transfusion</keyword>
  <keyword>Acute traumatic hemorrhage</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hemorrhage</mesh_term>
    <mesh_term>Multiple Trauma</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tranexamic Acid</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03780894
org study id: PRETIC
nct id: NCT03780894
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
This is a single-center, not-randomized, open-label, controlled pilot clinical trial. This
      study compares presence of Trauma Induced Coagulopathy (TIC) and acute traumatic hemorrhage
      treatment at pre-hospital phase of care with red blood cells (RBC), Tranexamic acid (TXA) and
      Fibrinogen Concentrate (FC) with the current treatment based on the administration of
      Crystalloids and TXA.
A pilot, non-randomized, open-label study of two intervention arms and controlled with the
      standard treatment in which 60 patients affected with acute hemorrhage due to severe trauma
      will enter the study with the main objective of evaluating the feasibility and the efficacy
      of early treatment during the pre-hospital care phase with packed red blood cells, fibrinogen
      concentrate and tranexamic acid (experimental arm) compared to the standard treatment based
      on crystalloids administration and tranexamic acid (control arm). The secondary objectives
      are to evaluate the safety and clinical evolution of the patients. Prior to the
      administration of the treatment, 2 blood samples will be extracted in both groups in order to
      compare the coagulation status and to be able to perform the pre-transfusion tests. On
      arrival at the hospital, another sample will be taken to compare changes in coagulation after
      the administration of the experimental or standard treatment and also between both groups.
      The assessment of the coagulation status will be made using the values provided by the
      viscoelastic test (TEG6s). The experimental and standard treatment will be administered
      endovenously. After treatment, patients will be evaluated up to 30 days.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: Single-center, non-randomized, open-label, two-arms, controlled pilot clinical trial.
The experimental and control arms will be determined according to the SEM units with RBC, TXA and FC administration capacity (i.e. helicopter unit, rapid intervention ambulance or advanced life support ambulance). The emergency SEM units are activated according current protocols based on distance, severity and weather conditions.
primary purpose: Treatment
masking: None (Open Label)
measure: TEG6s(R) parameters for Trauma Induced Coagulopathy (TIC)
time frame: Basal (at the crash site)
description: TEG6s(R) parameters that define TIC
measure: TEG6s(R) parameters for Trauma Induced Coagulopathy (TIC)
time frame: Basal (at the hospital arrival)
description: TEG6s(R) parameters that define TIC
measure: All-cause mortality
time frame: 1 hour post hospital admission
description: Mortality for any cause
measure: All-cause mortality
time frame: 6 hours post hospital admission
description: Mortality for any cause
measure: All-cause mortality
time frame: 24 hours post hospital admission
description: Mortality for any cause
measure: Accountability
time frame: 30 days
description: Red bood cells concentrate accountability
measure: Temperature storage conditions of the red blood cells concentrate
time frame: 24 hours
description: Red bood cells concentrate out of temperature range for storage
measure: All-cause mortality
time frame: 48 hours post hospital admission
description: Mortality for any cause
measure: All-cause mortality
time frame: 30 days post hospital admission
description: Mortality for any cause
measure: Adverse Events
time frame: 30 days post hospital admission (or previously at hospital discharge)
description: Treatment emergent adverse events
measure: Thromboembolism events
time frame: 30 days
description: Thromboembolism events
measure: Crystalloid fluid requirements
time frame: 1 hour (from the crash site to the hospital admission)
description: Volume of crystalloids required
measure: Crystalloid fluid requirements
time frame: 30 days post hospital admission (or previously at hospital discharge)
description: Volume of crystalloids required
measure: Transfusion requirements
time frame: 24 hours (or previously at discharge of the emergency room)
description: Transfusion requirements of RBC, platelets and plasma
measure: Transfusion requirements
time frame: 30 days post hospital admission (or previously at hospital discharge)
description: Transfusion requirements of RBC, platelets and plasma
measure: Water balance
time frame: 24 hours of admission at the ICU
description: Water balance at the Intensive Care Unit (ICU)
measure: Water balance
time frame: 72 hours of admission at the ICU
description: Water balance at the Intensive Care Unit (ICU)
measure: Ventilator-free days
time frame: 30 days
description: Ventilator-free days at the ICU
arm group label: Experimental treatment
arm group type: Experimental
description: The active treatment consists of intravenous injection of 2g of fibrinogen concentrate, 1g of tranexamic acid, 2 red bood cells concentrate O Rh(D) negative (Banc de Sang i Teixits, Barcelona, Spain), and crystalloids at pre-hospital phase of care.
arm group label: Standard treatment
arm group type: Active Comparator
description: Patients in the control arm will be treated according the existing protocols based on crystalloids and tranexamic acid administration.
intervention type: Drug
intervention name: Fibrinogen Concentrate (Human) 1 MG [RiaSTAP]
description: Administration of 2 mg of FC together with RBC and TXA
arm group label: Experimental treatment
intervention type: Biological
intervention name: Red blood cells concentrate
description: Administration of 2 red blood cells concentrates together with FC and TXA
arm group label: Experimental treatment
intervention type: Drug
intervention name: Tranexamic Acid
description: Administration of 1g of TXA together with FC and RBC
arm group label: Experimental treatment
arm group label: Standard treatment
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
facility: 
country: Spain
url: http://www.bancsang.net
description: Blood and Tissue Bank of Catalonia
url: http://icsgirona.cat
description: HOspital Universitari Dr. Trueta (Girona, Spain)
responsible party type: Sponsor
mesh term: Hemorrhage
mesh term: Multiple Trauma
mesh term: Tranexamic Acid
sharing ipd: No