<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/NCT04431999</url>
  </required_header>
  <id_info>
    <org_study_id>2019-A02706-51</org_study_id>
    <nct_id>NCT04431999</nct_id>
  </id_info>
  <brief_title>Evaluation of a Transfusion Therapy Using Whole Blood in the Management of Coagulopathy in Patients With Acute Traumatic Hemorrhage</brief_title>
  <acronym>T-STORHM</acronym>
  <official_title>Evaluation of a Transfusion Therapy Using Whole Blood Versus Fractionated Blood Products in the Management of Coagulopathy in Patients Admitted to Hospital for Acute Traumatic Hemorrhage</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Direction Centrale du Service de Santé des Armées</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>TIMC-IMAG</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Floralis</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Direction Centrale du Service de Santé des Armées</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The prognosis of traumatized hemorrhages is correlated with the nature of transfusion&#xD;
      therapy: a 50% reduction in mortality for an early and massive supply of plasma, and 20% for&#xD;
      an early and massive supply of platelets. However, this strategy encounters logistical&#xD;
      difficulties, particularly in a context of collective emergency (attacks). The use of whole&#xD;
      blood, widely documented by the Armed Forces, improves the availability of plasma and&#xD;
      platelets, and simplifies handling by the various actors in the chain.&#xD;
&#xD;
      T-STORHM is a randomized, controlled, parallel clinical trial.This study tests&#xD;
      non-inferiority of whole blood transfusion therapy in the management of coagulopathy in&#xD;
      patients with acute traumatic hemorrhage.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In recent years, terrorist attacks have confronted the investigator's healthcare system with&#xD;
      a massive influx of victims of war weapon injuries. This new fact makes the efficiency of&#xD;
      transfusion therapy crucial: hemorrhage is the leading cause of death from weapons of war,&#xD;
      and the high number of victims of each attack changes the logistical approach.&#xD;
&#xD;
      The logistical problems with transfusion therapy, including red blood cell (PRBCs), plasma&#xD;
      and platelet concentrates, are the speed of delivery and availability. Using whole blood is a&#xD;
      pragmatic solution to overcome these problems. This solution has been used for many years by&#xD;
      the French Army to ensure platelet transfusion in traumatic hemorrhages&#xD;
&#xD;
      The hypothesis of the T-STORHM study is that the use of whole blood is a solution in a&#xD;
      context of civil trauma not effective less than component therapy (PRBCs, plasma and platelet&#xD;
      concentrates) in the management of coagulopathy in patients admitted to hospital for&#xD;
      traumatic hemorrhage.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">December 4, 2021</start_date>
  <completion_date type="Anticipated">September 2025</completion_date>
  <primary_completion_date type="Anticipated">September 2024</primary_completion_date>
  <phase>Phase 3</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>
    <intervention_model_description>Multicenter, Controlled, Randomized, Open Labe Therapeutic Trial</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Non inferiority on the correction of coagulopathy, during emergency transfusion of bleeding trauma using whole blood compared to the use of component therapy (packed red blood cells, plasma units and platelets).</measure>
    <time_frame>6 hours following hospital admission</time_frame>
    <description>This outcome is measured on the correction of traumatic coagulopathy, measured by the value of a viscoelastometric parameter : the maximum amplitude (MA) (measured by a thromboelastogram).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Effectiveness of circulatory resuscitation</measure>
    <time_frame>2 hours following hospital admission</time_frame>
    <description>Proportion of patients with lactate clearance &gt; 20% per hour at H2.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mortality</measure>
    <time_frame>2 hours following hospital admission and Day 30 (or the last day of hospitalization)</time_frame>
    <description>Number of deaths.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mortality / Morbidity</measure>
    <time_frame>24 hours following hospital admission</time_frame>
    <description>Composite endpoint : Number of deaths at H24 or impairment of vital functions with a Sequential Organ Failure Assessment (SOFA) score greater than or equal to 12.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Impact on timeframe to obtain blood products</measure>
    <time_frame>2 and 6 hours following hospital admission</time_frame>
    <description>Time to obtain product ratios in accordance with recommendations.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Impact on time to start transfusion therapy</measure>
    <time_frame>Time between admission and transfusion therapy</time_frame>
    <description>Time to start transfusion therapy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evolution of coagulopathy.</measure>
    <time_frame>At inclusion, 2, 6 and 24 hours following hospital admission</time_frame>
    <description>All the parameters of the thrombelastography (TEG) (R/CK, alpha/CK, MA/CRT, LY30/CK, FF/CRT) allow to evaluate the coagulopathy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evolution of coagulopathy</measure>
    <time_frame>At inclusion, 2, 6 and 24 hours following hospital admission.</time_frame>
    <description>All the parameters of the coagulation (PT, APTT, fibrinogene) allow to evaluate the coagulopathy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tolerance of whole blood transfusion</measure>
    <time_frame>Day 1, Day 2</time_frame>
    <description>Hemolysis marker rate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Labile blood products transfused in the first 24 hours</measure>
    <time_frame>24 hours following hospital admission</time_frame>
    <description>Number of bags administered</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cost of the strategy</measure>
    <time_frame>Day 30 (or the last day of hospitalization)</time_frame>
    <description>Direct costs of transfusion and the cost of the ICU stay</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Biobank establishment</measure>
    <time_frame>Through study completion, an average of 3 years</time_frame>
    <description>To constitute biobank for biological measurements in research hemorrhagic shock pathophysiology of transfusion resuscitation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ancillary study n°1 : recirculation of storage microerythrocytes</measure>
    <time_frame>before and after transfusion resuscitation, Day 30 (or the last day of hospitalization).</time_frame>
    <description>Rate of storage microerythrocytes, monocyte quantification and phenotyping, splenic ultrasound</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ancillary study n°2 : evolution of microcirculation during transfusion resuscitation of hemorrhagic shock.</measure>
    <time_frame>During the transfusion resuscitation</time_frame>
    <description>Optical imaging technique of microvascular content to detect flow anomalies in microvessels.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Trauma</condition>
  <condition>Acute Hemorrhage</condition>
  <condition>Coagulopathy</condition>
  <arm_group>
    <arm_group_label>Whole blood group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Damage control resuscitation for trauma care using whole blood.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Fractionated blood products group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Damage control resuscitation for trauma care using component therapy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Whole blood transfusion</intervention_name>
    <description>Severe trauma patients with a life threatening bleeding will be managed with 3 whole blood bags for the 1st and 2nd pack. The later packs will consist of 3 packed red blood cells (PRBCs), 3 plasma units and 1 dose of platelets.</description>
    <arm_group_label>Whole blood group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fractionated blood products transfusion</intervention_name>
    <description>Severe trauma patients with a life threatening bleeding will be managed with 3 packed red blood cells (PRBCs), 3 lyophilised plasma units and 1 dose of platelets for the 1st. The 2nd pack will consist of 3 packed red blood cells (PRBCs) and 3 lyophilised plasma units. Then, the later pack will consist of 3 packed red blood cells (PRBCs), 3 plasma units and 1 dose of platelets.</description>
    <arm_group_label>Fractionated blood products group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Severe trauma patients requiring the initiation of a massive transfusion protocol&#xD;
        determined on&#xD;
&#xD;
          1. At least two Red flag score factors (according to pre-hospital data) :&#xD;
&#xD;
               -  Suspected pelvic fracture&#xD;
&#xD;
               -  Shock index (FC / PAS)&gt; = 1&#xD;
&#xD;
               -  Microdose hemoglobin &lt;13g&#xD;
&#xD;
               -  Average blood pressure &lt;70 mmHg&#xD;
&#xD;
               -  Need for prehospital tracheal intubation&#xD;
&#xD;
          2. AND at least two criteria of the Assessment of Blood Consumption (ABC) score&#xD;
             established at the patient's arrival:&#xD;
&#xD;
               -  Penetrating trauma&#xD;
&#xD;
               -  Focused Abdominal Sonography for Trauma (FAST) echo positive&#xD;
&#xD;
               -  Blood pressure &lt;90 mmHg&#xD;
&#xD;
               -  Respiratory rate &gt;120 bpm&#xD;
&#xD;
          3. AND/OR on the prediction of the practitioner (clinical diagnosis) in charge of the&#xD;
             treatment of the injured person of the need to transfuse at least 4 PRBCs within 6&#xD;
             hours after the admission of the trauma patient&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Non-traumatic hemorrhage&#xD;
&#xD;
          -  Patients transfused with more than two PRBCs before the initiation of the massive&#xD;
             transfusion protocol.&#xD;
&#xD;
          -  Anti-coagulation treatment&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Age &lt; 18 years&#xD;
&#xD;
          -  Patient refusing administration of blood products&#xD;
&#xD;
          -  Patient transferred from another hospital&#xD;
&#xD;
          -  Patient nor transported by a physician-staffed prehospital emergency medical system&#xD;
&#xD;
          -  Burn patient (≥30% of body surface).&#xD;
&#xD;
          -  Patient under specific known transfusion protocol (for example : allo immunization...)&#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>
  <overall_official>
    <last_name>Nathalie KOULMANN</last_name>
    <role>Study Director</role>
    <affiliation>Direction Centrale du Service de Santé des Armées (DCSSA)</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Sylvain AUSSET</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ecoles militaires de santé de Lyon-Bron</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jean-Luc BOSSON</last_name>
    <role>Principal Investigator</role>
    <affiliation>Statistical and methodological investigator - Laboratoire TIMC UMR 5525 CNRS Equipe Themas</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Sylvain AUSSET</last_name>
    <phone>+33 4 72 36 40 01</phone>
    <email>sylvain.ausset@def.gouv.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Christophe RENARD</last_name>
    <phone>+33 1 40 51 41 03</phone>
    <email>christophe1.renard@intradef.gouv.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>CHU de La Cavale Blanche - Brest</name>
      <address>
        <city>Brest</city>
        <zip>29200</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Philippe ARIES</last_name>
      <email>philippe.aries@chu-brest.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>HIA Percy</name>
      <address>
        <city>Clamart</city>
        <zip>92140</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Pierre PASQUIER</last_name>
      <email>pierre.pasquier@intradef.gouv.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>CHU de Grenoble</name>
      <address>
        <city>Grenoble</city>
        <zip>38000</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Pierre BOUZAT</last_name>
      <email>PBouzat@chu-grenoble.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>CHU de La Pitié-Salpêtrière</name>
      <address>
        <city>Paris</city>
        <zip>75013</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Mathieu RAUX</last_name>
      <email>mathieu.raux@aphp.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>CHU du Kremlin Bicêtre</name>
      <address>
        <city>Paris</city>
        <zip>94270</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Mathieu RAUX</last_name>
      <email>mathieu.raux@aphp.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>HIA Sainte Anne</name>
      <address>
        <city>Toulon</city>
        <zip>83000</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Eric Meaudre</last_name>
      <email>eric.meaudre-desgouttes@intradef.gouv.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
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  <verification_date>May 2023</verification_date>
  <study_first_submitted>May 28, 2020</study_first_submitted>
  <study_first_submitted_qc>June 12, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <last_update_submitted>May 16, 2023</last_update_submitted>
  <last_update_submitted_qc>May 16, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 17, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Whole Blood</keyword>
  <keyword>Acute traumatic coagulopathy</keyword>
  <keyword>Transfusion</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hemostatic Disorders</mesh_term>
    <mesh_term>Blood Coagulation Disorders</mesh_term>
    <mesh_term>Hemorrhage</mesh_term>
  </condition_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/NCT04431999
org study id: 2019-A02706-51
nct id: NCT04431999
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The prognosis of traumatized hemorrhages is correlated with the nature of transfusion
      therapy: a 50% reduction in mortality for an early and massive supply of plasma, and 20% for
      an early and massive supply of platelets. However, this strategy encounters logistical
      difficulties, particularly in a context of collective emergency (attacks). The use of whole
      blood, widely documented by the Armed Forces, improves the availability of plasma and
      platelets, and simplifies handling by the various actors in the chain.

      T-STORHM is a randomized, controlled, parallel clinical trial.This study tests
      non-inferiority of whole blood transfusion therapy in the management of coagulopathy in
      patients with acute traumatic hemorrhage.
In recent years, terrorist attacks have confronted the investigator's healthcare system with
      a massive influx of victims of war weapon injuries. This new fact makes the efficiency of
      transfusion therapy crucial: hemorrhage is the leading cause of death from weapons of war,
      and the high number of victims of each attack changes the logistical approach.

      The logistical problems with transfusion therapy, including red blood cell (PRBCs), plasma
      and platelet concentrates, are the speed of delivery and availability. Using whole blood is a
      pragmatic solution to overcome these problems. This solution has been used for many years by
      the French Army to ensure platelet transfusion in traumatic hemorrhages

      The hypothesis of the T-STORHM study is that the use of whole blood is a solution in a
      context of civil trauma not effective less than component therapy (PRBCs, plasma and platelet
      concentrates) in the management of coagulopathy in patients admitted to hospital for
      traumatic hemorrhage.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Multicenter, Controlled, Randomized, Open Labe Therapeutic Trial
primary purpose: Treatment
masking: None (Open Label)
measure: Non inferiority on the correction of coagulopathy, during emergency transfusion of bleeding trauma using whole blood compared to the use of component therapy (packed red blood cells, plasma units and platelets).
time frame: 6 hours following hospital admission
description: This outcome is measured on the correction of traumatic coagulopathy, measured by the value of a viscoelastometric parameter : the maximum amplitude (MA) (measured by a thromboelastogram).
measure: Effectiveness of circulatory resuscitation
time frame: 2 hours following hospital admission
description: Proportion of patients with lactate clearance > 20% per hour at H2.
measure: Mortality
time frame: 2 hours following hospital admission and Day 30 (or the last day of hospitalization)
description: Number of deaths.
measure: Mortality / Morbidity
time frame: 24 hours following hospital admission
description: Composite endpoint : Number of deaths at H24 or impairment of vital functions with a Sequential Organ Failure Assessment (SOFA) score greater than or equal to 12.
measure: Impact on timeframe to obtain blood products
time frame: 2 and 6 hours following hospital admission
description: Time to obtain product ratios in accordance with recommendations.
measure: Impact on time to start transfusion therapy
time frame: Time between admission and transfusion therapy
description: Time to start transfusion therapy.
measure: Evolution of coagulopathy.
time frame: At inclusion, 2, 6 and 24 hours following hospital admission
description: All the parameters of the thrombelastography (TEG) (R/CK, alpha/CK, MA/CRT, LY30/CK, FF/CRT) allow to evaluate the coagulopathy.
measure: Evolution of coagulopathy
time frame: At inclusion, 2, 6 and 24 hours following hospital admission.
description: All the parameters of the coagulation (PT, APTT, fibrinogene) allow to evaluate the coagulopathy.
measure: Tolerance of whole blood transfusion
time frame: Day 1, Day 2
description: Hemolysis marker rate
measure: Labile blood products transfused in the first 24 hours
time frame: 24 hours following hospital admission
description: Number of bags administered
measure: Cost of the strategy
time frame: Day 30 (or the last day of hospitalization)
description: Direct costs of transfusion and the cost of the ICU stay
measure: Biobank establishment
time frame: Through study completion, an average of 3 years
description: To constitute biobank for biological measurements in research hemorrhagic shock pathophysiology of transfusion resuscitation.
measure: Ancillary study n°1 : recirculation of storage microerythrocytes
time frame: before and after transfusion resuscitation, Day 30 (or the last day of hospitalization).
description: Rate of storage microerythrocytes, monocyte quantification and phenotyping, splenic ultrasound
measure: Ancillary study n°2 : evolution of microcirculation during transfusion resuscitation of hemorrhagic shock.
time frame: During the transfusion resuscitation
description: Optical imaging technique of microvascular content to detect flow anomalies in microvessels.
arm group label: Whole blood group
arm group type: Experimental
description: Damage control resuscitation for trauma care using whole blood.
arm group label: Fractionated blood products group
arm group type: Active Comparator
description: Damage control resuscitation for trauma care using component therapy.
intervention type: Drug
intervention name: Whole blood transfusion
description: Severe trauma patients with a life threatening bleeding will be managed with 3 whole blood bags for the 1st and 2nd pack. The later packs will consist of 3 packed red blood cells (PRBCs), 3 plasma units and 1 dose of platelets.
arm group label: Whole blood group
intervention type: Drug
intervention name: Fractionated blood products transfusion
description: Severe trauma patients with a life threatening bleeding will be managed with 3 packed red blood cells (PRBCs), 3 lyophilised plasma units and 1 dose of platelets for the 1st. The 2nd pack will consist of 3 packed red blood cells (PRBCs) and 3 lyophilised plasma units. Then, the later pack will consist of 3 packed red blood cells (PRBCs), 3 plasma units and 1 dose of platelets.
arm group label: Fractionated blood products group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Nathalie KOULMANN
role: Study Director
affiliation: Direction Centrale du Service de Santé des Armées (DCSSA)
last name: Sylvain AUSSET
role: Principal Investigator
affiliation: Ecoles militaires de santé de Lyon-Bron
last name: Jean-Luc BOSSON
role: Principal Investigator
affiliation: Statistical and methodological investigator - Laboratoire TIMC UMR 5525 CNRS Equipe Themas
last name: Sylvain AUSSET
phone: +33 4 72 36 40 01
email: sylvain.ausset@def.gouv.fr
last name: Christophe RENARD
phone: +33 1 40 51 41 03
email: christophe1.renard@intradef.gouv.fr
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: France
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PMID: 23021369
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responsible party type: Sponsor
mesh term: Hemostatic Disorders
mesh term: Blood Coagulation Disorders
mesh term: Hemorrhage
sharing ipd: No