xml: <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/NCT06007807</url>
    </required_header>
    <id_info>
      <org_study_id>ICUTRAUMA</org_study_id>
      <nct_id>NCT06007807</nct_id>
    </id_info>
    <brief_title>Severe Trauma Registry in Tarragona</brief_title>
    <acronym>IcuTrauma</acronym>
    <official_title>Registry of Patients With Severe Trauma Admitted to the ICU in Tarragona</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Hospital Universitari Joan XXIII de Tarragona.</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Hospital Universitari Joan XXIII de Tarragona.</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>
    </oversight_info>
    <brief_summary>
      <textblock>
        Severe trauma is one of the leading causes of morbidity, mortality, and disability worldwide.&#xD;
        Currently, it is the primary cause of death among individuals under 45 years of age. This&#xD;
        disease, considered a &quot;silent pandemic,&quot; exhibits heterogeneous physiopathology and unequal&#xD;
        geographic distribution in terms of the type of injuries. The prognosis of subjects who have&#xD;
        suffered severe trauma is uncertain, especially in patients with traumatic brain injury.&#xD;
  &#xD;
        The epidemiology of severe trauma has undergone changes in recent years due to the global&#xD;
        aging of society, resulting in different populations with older ages and more associated&#xD;
        comorbidities. These factors are frequently linked to the use of chronic treatments such as&#xD;
        antiplatelet agents or anticoagulants, which could worsen traumatic hemorrhage-the leading&#xD;
        preventable cause of death following severe trauma. Despite efforts for primary prevention,&#xD;
        such as road safety campaigns and occupational risk prevention, the annual incidence of&#xD;
        severe trauma cases worldwide remains high. Enhancing the management of trauma patients would&#xD;
        significantly influence the final clinical outcomes.&#xD;
  &#xD;
        Given the aforementioned, it is of vital importance to understand the local epidemiology of&#xD;
        severe trauma for the development of clinical research. This constitutes an effective tool to&#xD;
        investigate changes in clinical practices, improve prevention strategies, and determine the&#xD;
        global burden of the disease.&#xD;
  &#xD;
        The hypothesis of the IcuTrauma Project is to create a territorial Registry of adults with&#xD;
        severe trauma admitted to the ICU to understand the local epidemiology in Tarragona (Spain).&#xD;
        This initiative would facilitate new lines of clinical research aimed at improving outcomes&#xD;
        and the quality of care for trauma patients.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        -  Study design: observational, retrospective, one centre (Hospital Universitari Joan&#xD;
             XXIII) in Tarragona, Catalonia, Spain.&#xD;
  &#xD;
          -  Study period: Seven-years period: Since 01 January 2015 - 31 December 2022 (The registry&#xD;
             will be open and active recruiting after this time point).&#xD;
  &#xD;
          -  Sample size calculation: Not applicable. The sample size will be equal to the total&#xD;
             number of patients consecutively admitted to the Intensive Care Unit (ICU) due to severe&#xD;
             trauma during the study period.&#xD;
  &#xD;
          -  Data extraction:&#xD;
  &#xD;
        Data will be extracted by twofold:&#xD;
  &#xD;
          1. Hand-driven: extracted data from the medical reports by reviewing the clinical history&#xD;
             system performed by the study investigators, who are part of the staff of the ICU&#xD;
             involved in the care of trauma patients. This information was collected into a&#xD;
             large-scale database and, once introduced, the data was checked and verified by two&#xD;
             investigators (and principal investigator).&#xD;
  &#xD;
             These manually extracted data included pre-hospital variables (such as the time of the&#xD;
             injury, the mechanism of injury, first vital signs, pre-hospital procedures),&#xD;
             in-hospital information (demographic's, primary survey of trauma in emergency&#xD;
             department-ED, use of Extended Focused Assesment with Sonography in Trauma, complete&#xD;
             laboratory results in ED), description of detailed anatomic injuries (Traumatic Brain&#xD;
             Injury-TBI, thoracic trauma, abdominal trauma, Pelvic trauma, orthopedic injuries),&#xD;
             severity scores (Acute Physiology And Chronic Health Evaluation-APACHE II, Sequential&#xD;
             Organ Failure Assessment-SOFA score, Injury Severity Score-ISS, Abbreviated Injury&#xD;
             Score-AIS, etc), resources during ICU admission (surgeries, transfusions, organ support,&#xD;
             etc), complications (organ failures and nosocomial infections such as&#xD;
             ventilator-associated pneumonia, catheter-related infection, etc), and clinical outcomes&#xD;
             (ICU mortality, cause of death, in-hospital mortality, one-year survival, mechanical&#xD;
             ventilation days, ICU and hospital length of stay, disability at ICU discharge and&#xD;
             destination at discharge.&#xD;
  &#xD;
          2. Automatic data: automated data collected with the Electronic Health System (Centricity&#xD;
             Critical Care) provide solid and valid extraction of information. Automatic variables&#xD;
             were checked and validated by the expert and specialized members of the ICU in data&#xD;
             quality assessment and the management of data to ensure that recorded information was&#xD;
             reliable. The accuracy, completeness and representativeness of automatic data was double&#xD;
             checked when entered into the large-scale database for data quality by the principal&#xD;
             investigator and a biotechnologist, who were responsible for the quality assurance plan&#xD;
             that addressed data validation, monitoring and auditing (identifying inconsistencies,&#xD;
             outliers or incorrect ranges for variables entered into the registry). The automated&#xD;
             variables collected (not recorded manually) included demographic data, comorbidities and&#xD;
             previous risk factors, dates (hospital and ICU admission, hospital and ICU discharge),&#xD;
             laboratory tests during the first week of ICU admission, resources consumption during&#xD;
             ICU stay, complications during ICU admission and outcomes.&#xD;
  &#xD;
               -  Statistical plan: descriptive and analytical statistics using binary logistic&#xD;
                  regression (for association), survival analysis with Kaplan Meier analysis and Cox&#xD;
                  regression (for clinical outcomes), nonlinear association test such as CHAID&#xD;
                  decision analysis and restricted cubic splines, and matching learning analysis (for&#xD;
                  cluster or subgroups identification). These analyzes will be carried out using SPSS&#xD;
                  v24 and R software. Missing data values of automated variables will be handled&#xD;
                  using multiple imputation. Hand-driven data had negligible missing values.&#xD;
  &#xD;
               -  Variable definitions (all definitions met the ATLS-Advanced Trauma Life Support&#xD;
                  criteria):&#xD;
  &#xD;
                    -  Previous anticoagulants or antiplatelet agents: chronic use of aspirin,&#xD;
                       clopidogrel, other antiplatelet agents, acenocumarol, warfarin, new&#xD;
                       anticoagulants.&#xD;
  &#xD;
                    -  Pre-hospital airway protection: includes supraglottic device, orotracheal&#xD;
                       intubation or surgical airway protection.&#xD;
  &#xD;
                    -  Penetrating trauma: knifes, firearm, impalement or others.&#xD;
  &#xD;
                    -  Flail chest: more than 3 ribs with fracture in two points.&#xD;
  &#xD;
                    -  Lung contusion: pulmonary infiltrate or condensation on initial X-rays after&#xD;
                       trauma.&#xD;
  &#xD;
                    -  Hemothorax type: simple (any pleural fluid detected after trauma), massive&#xD;
                       (&gt;1.5 Liters acute or &gt; 200cc/h in 2-4 hours).&#xD;
  &#xD;
                    -  Type of pneumothorax: simple (presence of aire in pleural space), hypertensive&#xD;
                       (with hypotension and/or respiratory failure).&#xD;
  &#xD;
                    -  Myocardial dysfunction (ventricular dysfunction detected in echocardiography&#xD;
                       or worsening of previous cardiac dysfunction).&#xD;
  &#xD;
                    -  Abdominal injuries grade (hepatic, spleen and renal trauma): anatomical scale&#xD;
                       injury using the AAST-The American Association for the Surgery of Trauma.&#xD;
  &#xD;
                    -  Pelvic fracture classification: Young-Burgees pelvic ring injury&#xD;
                       classification.&#xD;
  &#xD;
                    -  Neurogenic shock: bradycardia with hypoperfusion.&#xD;
  &#xD;
                    -  Urgent surgery: first 24 hours after trauma.&#xD;
  &#xD;
                    -  Hemorragia shock: hypoperfusion (with or without hypotension) defined by&#xD;
                       tachicardia, coldness, peripheral vasoconstriction, need for vasopressors,&#xD;
                       altered mental status, oliguria, hyperlactatemia or base excess deficit &lt; - 6&#xD;
                       due to the loss of blood after injury.&#xD;
  &#xD;
                    -  Damage control surgery: Non-definitive surgery consisting in packing for&#xD;
                       hemorrhage control, open abdomen, intestinal contamination control.&#xD;
  &#xD;
                    -  Massive hemorrhage: &gt;10 CH in the first 24 hours, life-threatening hemorrhage,&#xD;
                       or &gt; four blood products in the first 2 hours after admission.&#xD;
  &#xD;
                    -  Intracranial hypertension (ICH): episode of Intracranial pressures &gt; 20-22&#xD;
                       mmHg maintained for more than five minutes.&#xD;
  &#xD;
                    -  First level of ICH measures: general measures, sedation, neuromuscular&#xD;
                       blockade, ventricular drainage, osmotherapy.&#xD;
  &#xD;
                    -  Second level of ICH measures: decompressive craniectomy or brabiturics&#xD;
                       administration.&#xD;
  &#xD;
                    -  Osmotherapy: administration of hypertonic saline or mannitol during admission.&#xD;
  &#xD;
                    -  Intracranial rebleeding: increase in hematoma volume from initial tomography&#xD;
                       (CT scan).&#xD;
  &#xD;
                    -  Organ donor: organ donation.&#xD;
  &#xD;
                    -  ARDS (Acute respiratory distress syndrome): according the Berlin criteria.&#xD;
  &#xD;
                    -  Protective mechanical ventilation: applying tidal volumes 6-8 ml/Kg ideal body&#xD;
                       weight.&#xD;
  &#xD;
                    -  Free liquid CT: neither solid nor hollow viscera injury.&#xD;
  &#xD;
                    -  Non-operative management (NOM) for abdominal trauma: solid organ injury&#xD;
                       detected in CT scan managed through conservative management (no need for&#xD;
                       surgery at least 6-8 hours).&#xD;
  &#xD;
                    -  MNO failure: urgent laparotomy after deciding NOM.&#xD;
  &#xD;
                    -  White laparotomy: absence of lesions observed in the laparotomy.&#xD;
  &#xD;
                    -  Abdominal compartment syndrome: results from the progression of steady-state&#xD;
                       pressure within the abdominal cavity to a repeated pathological elevation of&#xD;
                       pressure above 20mmHg with associated organ dysfunction.&#xD;
  &#xD;
                    -  Early MODS (Multiorgan dysfunction syndrome): dysfunction of two or more&#xD;
                       organs in the first 72 hours after trauma.&#xD;
  &#xD;
                    -  Renal failure: according to AKIN guidelines.&#xD;
  &#xD;
                    -  Trauma-induced Coagulopathy (TIC): prolongation of the prothrombin and&#xD;
                       activated partial thromboplastin times over 1.5 times the control values, or&#xD;
                       fibrinogen &lt; 150 mg/dL or thrombocytopenia &lt; 100.000/ml in the first 72 hours&#xD;
                       after trauma.&#xD;
  &#xD;
                    -  Septic shock: identification of sepsis plus organ failure or tissue&#xD;
                       hypoperfusion.&#xD;
  &#xD;
                    -  Thrombosis: any type (deep vein thrombosis, arterial, pulmonary embolism).&#xD;
  &#xD;
                    -  Tracheostomy: percutaneous or surgical.&#xD;
  &#xD;
                    -  Nosocomial infection: any infection diagnosed after 48 hours of ICU admission.&#xD;
  &#xD;
                    -  VAP (Ventilator-associated pneumonia): clinical and microbiologically&#xD;
                       confirmed pneumonia in patients ventilated for at least 48 hours.&#xD;
  &#xD;
                    -  VAT (Ventilator-associated tracheobronchitis): upper respiratory tract&#xD;
                       infection (without pneumonia) in patients ventilated for at least 48h.&#xD;
  &#xD;
                    -  CRI (Catheter-related infection): bacteremia with positive catheter culture&#xD;
                       for the same microorganism and no other source of infection, with a minimum of&#xD;
                       15 colony formation units in the catheter culture.&#xD;
  &#xD;
               -  Intra-abdominal infection: peritonitis, abscess, positive surgical fluid.&#xD;
  &#xD;
               -  Infection of open fractures: positive culture of the wound.&#xD;
  &#xD;
               -  MDR (multidrug resistant) infection: includes any bacteria resistant to at least&#xD;
                  three antibiotic families.&#xD;
  &#xD;
               -  Limitation of life support: withholding or withdrawal.&#xD;
  &#xD;
               -  Causes of death: hemorrhagic shock, early MODS, late MODS, septic shock, refractory&#xD;
                  ICH (without response to applied measures), others.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">January 1, 2015</start_date>
    <completion_date type="Actual">December 31, 2022</completion_date>
    <primary_completion_date type="Actual">December 31, 2022</primary_completion_date>
    <study_type>Observational [Patient Registry]</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Other</time_perspective>
    </study_design_info>
    <target_duration>1 Year</target_duration>
    <primary_outcome>
      <measure>ICU mortality</measure>
      <time_frame>Time (in days) between ICU admission date and ICU discharge date</time_frame>
      <description>proportion of deaths</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Length of stay (LOS)</measure>
      <time_frame>Time (in days) between hospital admission date and hospital discharge date</time_frame>
      <description>Hospital length of stay</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mechanical ventilation duration</measure>
      <time_frame>During the invasive mechanical ventilation treatment</time_frame>
      <description>Total duration and Ventilator-free days</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>In-hospital mortality</measure>
      <time_frame>at 28 day</time_frame>
      <description>Proportion of deaths</description>
    </secondary_outcome>
    <enrollment type="Actual">1000</enrollment>
    <condition>Major Trauma</condition>
    <condition>Traumatic Brain Injury</condition>
    <eligibility>
      <study_pop>
        <textblock>
          Patients presenting a severe trauma in the province of Tarragona and transferred to the&#xD;
          Joan XXIII Hospital (Tarragona City), either as primary or secondary transfer. The&#xD;
          ICUTRAUMA project was conducted in one center (Joan XXIII University Hospital), which is&#xD;
          the reference center in the province. It is a Level II Trauma Center. It has 24-hours&#xD;
          neurosurgery and ICU availability, being the reference centre in the province for patients&#xD;
          with TBI. The Joan XXIII Hospital receives patients with severe trauma from other six&#xD;
          centers. The entire province covers a total surface area of 6,302 km2 with almost 1M&#xD;
          inhabitants. According to our general data, more than 400 patients are admitted to the&#xD;
          hospital emergency department each year, of which more than 100 patients require admission&#xD;
          to the ICU.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Adults who were consecutevely admitted to the ICU for severe trauma during the study&#xD;
               period.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Children aged &lt; 15 years old.&#xD;
  &#xD;
            -  Trauma admitted outside the ICU&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>15 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Gerard Moreno, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Hospital Universitari Joan XXIII</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Hospital Universitari Joan XXIII</name>
        <address>
          <city>Tarragona</city>
          <state>Catalonia/Tarragona</state>
          <zip>43005</zip>
          <country>Spain</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Spain</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 4, 2023</study_first_submitted>
    <study_first_submitted_qc>August 18, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 23, 2023</study_first_posted>
    <last_update_submitted>August 18, 2023</last_update_submitted>
    <last_update_submitted_qc>August 18, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 23, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Hospital Universitari Joan XXIII de Tarragona.</investigator_affiliation>
      <investigator_full_name>Gerard Moreno</investigator_full_name>
      <investigator_title>PhD, Staff of Intensive Care Unit</investigator_title>
    </responsible_party>
    <keyword>Severe trauma</keyword>
    <keyword>Traumatic Brain Injury</keyword>
    <keyword>ICU</keyword>
    <keyword>Mortality</keyword>
    <keyword>Trauma-induced coagulopathy</keyword>
    <keyword>Hemorrhage</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Brain Injuries</mesh_term>
      <mesh_term>Brain Injuries, Traumatic</mesh_term>
      <mesh_term>Wounds and Injuries</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06007807
  org study id: ICUTRAUMA
  nct id: NCT06007807
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Severe trauma is one of the leading causes of morbidity, mortality, and disability worldwide.
        Currently, it is the primary cause of death among individuals under 45 years of age. This
        disease, considered a "silent pandemic," exhibits heterogeneous physiopathology and unequal
        geographic distribution in terms of the type of injuries. The prognosis of subjects who have
        suffered severe trauma is uncertain, especially in patients with traumatic brain injury.
  
        The epidemiology of severe trauma has undergone changes in recent years due to the global
        aging of society, resulting in different populations with older ages and more associated
        comorbidities. These factors are frequently linked to the use of chronic treatments such as
        antiplatelet agents or anticoagulants, which could worsen traumatic hemorrhage-the leading
        preventable cause of death following severe trauma. Despite efforts for primary prevention,
        such as road safety campaigns and occupational risk prevention, the annual incidence of
        severe trauma cases worldwide remains high. Enhancing the management of trauma patients would
        significantly influence the final clinical outcomes.
  
        Given the aforementioned, it is of vital importance to understand the local epidemiology of
        severe trauma for the development of clinical research. This constitutes an effective tool to
        investigate changes in clinical practices, improve prevention strategies, and determine the
        global burden of the disease.
  
        The hypothesis of the IcuTrauma Project is to create a territorial Registry of adults with
        severe trauma admitted to the ICU to understand the local epidemiology in Tarragona (Spain).
        This initiative would facilitate new lines of clinical research aimed at improving outcomes
        and the quality of care for trauma patients.
  -  Study design: observational, retrospective, one centre (Hospital Universitari Joan
             XXIII) in Tarragona, Catalonia, Spain.
  
          -  Study period: Seven-years period: Since 01 January 2015 - 31 December 2022 (The registry
             will be open and active recruiting after this time point).
  
          -  Sample size calculation: Not applicable. The sample size will be equal to the total
             number of patients consecutively admitted to the Intensive Care Unit (ICU) due to severe
             trauma during the study period.
  
          -  Data extraction:
  
        Data will be extracted by twofold:
  
          1. Hand-driven: extracted data from the medical reports by reviewing the clinical history
             system performed by the study investigators, who are part of the staff of the ICU
             involved in the care of trauma patients. This information was collected into a
             large-scale database and, once introduced, the data was checked and verified by two
             investigators (and principal investigator).
  
             These manually extracted data included pre-hospital variables (such as the time of the
             injury, the mechanism of injury, first vital signs, pre-hospital procedures),
             in-hospital information (demographic's, primary survey of trauma in emergency
             department-ED, use of Extended Focused Assesment with Sonography in Trauma, complete
             laboratory results in ED), description of detailed anatomic injuries (Traumatic Brain
             Injury-TBI, thoracic trauma, abdominal trauma, Pelvic trauma, orthopedic injuries),
             severity scores (Acute Physiology And Chronic Health Evaluation-APACHE II, Sequential
             Organ Failure Assessment-SOFA score, Injury Severity Score-ISS, Abbreviated Injury
             Score-AIS, etc), resources during ICU admission (surgeries, transfusions, organ support,
             etc), complications (organ failures and nosocomial infections such as
             ventilator-associated pneumonia, catheter-related infection, etc), and clinical outcomes
             (ICU mortality, cause of death, in-hospital mortality, one-year survival, mechanical
             ventilation days, ICU and hospital length of stay, disability at ICU discharge and
             destination at discharge.
  
          2. Automatic data: automated data collected with the Electronic Health System (Centricity
             Critical Care) provide solid and valid extraction of information. Automatic variables
             were checked and validated by the expert and specialized members of the ICU in data
             quality assessment and the management of data to ensure that recorded information was
             reliable. The accuracy, completeness and representativeness of automatic data was double
             checked when entered into the large-scale database for data quality by the principal
             investigator and a biotechnologist, who were responsible for the quality assurance plan
             that addressed data validation, monitoring and auditing (identifying inconsistencies,
             outliers or incorrect ranges for variables entered into the registry). The automated
             variables collected (not recorded manually) included demographic data, comorbidities and
             previous risk factors, dates (hospital and ICU admission, hospital and ICU discharge),
             laboratory tests during the first week of ICU admission, resources consumption during
             ICU stay, complications during ICU admission and outcomes.
  
               -  Statistical plan: descriptive and analytical statistics using binary logistic
                  regression (for association), survival analysis with Kaplan Meier analysis and Cox
                  regression (for clinical outcomes), nonlinear association test such as CHAID
                  decision analysis and restricted cubic splines, and matching learning analysis (for
                  cluster or subgroups identification). These analyzes will be carried out using SPSS
                  v24 and R software. Missing data values of automated variables will be handled
                  using multiple imputation. Hand-driven data had negligible missing values.
  
               -  Variable definitions (all definitions met the ATLS-Advanced Trauma Life Support
                  criteria):
  
                    -  Previous anticoagulants or antiplatelet agents: chronic use of aspirin,
                       clopidogrel, other antiplatelet agents, acenocumarol, warfarin, new
                       anticoagulants.
  
                    -  Pre-hospital airway protection: includes supraglottic device, orotracheal
                       intubation or surgical airway protection.
  
                    -  Penetrating trauma: knifes, firearm, impalement or others.
  
                    -  Flail chest: more than 3 ribs with fracture in two points.
  
                    -  Lung contusion: pulmonary infiltrate or condensation on initial X-rays after
                       trauma.
  
                    -  Hemothorax type: simple (any pleural fluid detected after trauma), massive
                       (>1.5 Liters acute or > 200cc/h in 2-4 hours).
  
                    -  Type of pneumothorax: simple (presence of aire in pleural space), hypertensive
                       (with hypotension and/or respiratory failure).
  
                    -  Myocardial dysfunction (ventricular dysfunction detected in echocardiography
                       or worsening of previous cardiac dysfunction).
  
                    -  Abdominal injuries grade (hepatic, spleen and renal trauma): anatomical scale
                       injury using the AAST-The American Association for the Surgery of Trauma.
  
                    -  Pelvic fracture classification: Young-Burgees pelvic ring injury
                       classification.
  
                    -  Neurogenic shock: bradycardia with hypoperfusion.
  
                    -  Urgent surgery: first 24 hours after trauma.
  
                    -  Hemorragia shock: hypoperfusion (with or without hypotension) defined by
                       tachicardia, coldness, peripheral vasoconstriction, need for vasopressors,
                       altered mental status, oliguria, hyperlactatemia or base excess deficit < - 6
                       due to the loss of blood after injury.
  
                    -  Damage control surgery: Non-definitive surgery consisting in packing for
                       hemorrhage control, open abdomen, intestinal contamination control.
  
                    -  Massive hemorrhage: >10 CH in the first 24 hours, life-threatening hemorrhage,
                       or > four blood products in the first 2 hours after admission.
  
                    -  Intracranial hypertension (ICH): episode of Intracranial pressures > 20-22
                       mmHg maintained for more than five minutes.
  
                    -  First level of ICH measures: general measures, sedation, neuromuscular
                       blockade, ventricular drainage, osmotherapy.
  
                    -  Second level of ICH measures: decompressive craniectomy or brabiturics
                       administration.
  
                    -  Osmotherapy: administration of hypertonic saline or mannitol during admission.
  
                    -  Intracranial rebleeding: increase in hematoma volume from initial tomography
                       (CT scan).
  
                    -  Organ donor: organ donation.
  
                    -  ARDS (Acute respiratory distress syndrome): according the Berlin criteria.
  
                    -  Protective mechanical ventilation: applying tidal volumes 6-8 ml/Kg ideal body
                       weight.
  
                    -  Free liquid CT: neither solid nor hollow viscera injury.
  
                    -  Non-operative management (NOM) for abdominal trauma: solid organ injury
                       detected in CT scan managed through conservative management (no need for
                       surgery at least 6-8 hours).
  
                    -  MNO failure: urgent laparotomy after deciding NOM.
  
                    -  White laparotomy: absence of lesions observed in the laparotomy.
  
                    -  Abdominal compartment syndrome: results from the progression of steady-state
                       pressure within the abdominal cavity to a repeated pathological elevation of
                       pressure above 20mmHg with associated organ dysfunction.
  
                    -  Early MODS (Multiorgan dysfunction syndrome): dysfunction of two or more
                       organs in the first 72 hours after trauma.
  
                    -  Renal failure: according to AKIN guidelines.
  
                    -  Trauma-induced Coagulopathy (TIC): prolongation of the prothrombin and
                       activated partial thromboplastin times over 1.5 times the control values, or
                       fibrinogen < 150 mg/dL or thrombocytopenia < 100.000/ml in the first 72 hours
                       after trauma.
  
                    -  Septic shock: identification of sepsis plus organ failure or tissue
                       hypoperfusion.
  
                    -  Thrombosis: any type (deep vein thrombosis, arterial, pulmonary embolism).
  
                    -  Tracheostomy: percutaneous or surgical.
  
                    -  Nosocomial infection: any infection diagnosed after 48 hours of ICU admission.
  
                    -  VAP (Ventilator-associated pneumonia): clinical and microbiologically
                       confirmed pneumonia in patients ventilated for at least 48 hours.
  
                    -  VAT (Ventilator-associated tracheobronchitis): upper respiratory tract
                       infection (without pneumonia) in patients ventilated for at least 48h.
  
                    -  CRI (Catheter-related infection): bacteremia with positive catheter culture
                       for the same microorganism and no other source of infection, with a minimum of
                       15 colony formation units in the catheter culture.
  
               -  Intra-abdominal infection: peritonitis, abscess, positive surgical fluid.
  
               -  Infection of open fractures: positive culture of the wound.
  
               -  MDR (multidrug resistant) infection: includes any bacteria resistant to at least
                  three antibiotic families.
  
               -  Limitation of life support: withholding or withdrawal.
  
               -  Causes of death: hemorrhagic shock, early MODS, late MODS, septic shock, refractory
                  ICH (without response to applied measures), others.
  observational model: Cohort
  time perspective: Other
  measure: ICU mortality
  time frame: Time (in days) between ICU admission date and ICU discharge date
  description: proportion of deaths
  measure: Length of stay (LOS)
  time frame: Time (in days) between hospital admission date and hospital discharge date
  description: Hospital length of stay
  measure: Mechanical ventilation duration
  time frame: During the invasive mechanical ventilation treatment
  description: Total duration and Ventilator-free days
  measure: In-hospital mortality
  time frame: at 28 day
  description: Proportion of deaths
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 15 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Gerard Moreno, PhD
  role: Principal Investigator
  affiliation: Hospital Universitari Joan XXIII
  facility: 
  country: Spain
  responsible party type: Principal Investigator
  investigator affiliation: Hospital Universitari Joan XXIII de Tarragona.
  investigator full name: Gerard Moreno
  investigator title: PhD, Staff of Intensive Care Unit
  mesh term: Brain Injuries
  mesh term: Brain Injuries, Traumatic
  mesh term: Wounds and Injuries