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/NCT05996068</url>
    </required_header>
    <id_info>
      <org_study_id>202210095DINC</org_study_id>
      <nct_id>NCT05996068</nct_id>
    </id_info>
    <brief_title>Arterial Line in Trauma Resuscitation</brief_title>
    <acronym>ALTR</acronym>
    <official_title>Enhancing Trauma Resuscitation Through Arterial Line Integration: A Before-After Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>National Taiwan University Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>National Taiwan University Hospital</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>
        Accident-related deaths is the 7th leading cause of death in Taiwan, and most of them is due&#xD;
        to trauma from falls and traffic accident. Among trauma patients, the common cause of death&#xD;
        is from hemorrhagic shock. Thus, real-time and accurate blood pressure monitoring is&#xD;
        important for trauma patients. Incorrect blood pressure monitoring can lead to adverse events&#xD;
        like traumatic cardiac arrest and shock and can also delay the time for intervention (fluid&#xD;
        resuscitation, blood transfusion and operation). The current practice of blood pressure&#xD;
        monitoring in trauma patient is by non-invasive blood pressure monitoring, which may be&#xD;
        incorrect and not timely. Patient's body type and peripheral perfusion can both influence the&#xD;
        result of non-invasive blood pressure monitoring.&#xD;
  &#xD;
        With continuous and correct blood pressure monitoring, the resuscitation team can give&#xD;
        adequate and timely treatment. In some trauma centers, arterial line insertion in trauma&#xD;
        patients is a daily practice, while the evidence is inadequate and the potential benefit in&#xD;
        unknown.&#xD;
  &#xD;
        The main purpose of this study is to investigate the application of arterial line insertion&#xD;
        in trauma patients. The study design is a prospective before-after study to exam whether&#xD;
        arterial line insertion in trauma patients can reduce adverse event rate like hypovolemic&#xD;
        shock and improve patient's outcomes.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">January 1, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2023</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <intervention_model_description>We use se before-after study type and only the after phase receive intervention. Before phase will retrospectively collect data from patient without arterial line intervention.</intervention_model_description>
      <primary_purpose>Diagnostic</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>composite primary endpoint (including any hypotension, vasopressors usage, any cardiac arrest in ER, Shock index )</measure>
      <time_frame>during ER stay, up to 6 hours</time_frame>
      <description>including any hypotension, vasopressors usage, any cardiac arrest in ER, Shock index (HR/SBP)&gt;1</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>prolong ICU admission</measure>
      <time_frame>up to 7 days</time_frame>
      <description>define as &gt; 6 days of admission</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>30 days mortality rate</measure>
      <time_frame>mortality within 30 days of trauma event</time_frame>
      <description>mortality within 30 days of trauma event</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>volume of fluid administration</measure>
      <time_frame>during ER stay, up to 6 hours</time_frame>
      <description>any type of fluid administration</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>units of red blood cell transfusion</measure>
      <time_frame>during ER stay, up to 6 hours</time_frame>
      <description>units of red blood cell transfusion</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">216</enrollment>
    <condition>Major Trauma</condition>
    <arm_group>
      <arm_group_label>trauma patients with arterial line insertion</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>the after phase, actively recruited patients who are eligible for arterial line insertion</description>
    </arm_group>
    <arm_group>
      <arm_group_label>trauma patients without arterial line insertion</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>the before phase, retrospectively data collection from the past</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>arterial line</intervention_name>
      <description>insert arterial line for patients who meet major trauma criteria</description>
      <arm_group_label>trauma patients with arterial line insertion</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Glasgow Coma Scale (GCS) 13 or less&#xD;
  &#xD;
            -  SBP &lt; 90 mmHg&#xD;
  &#xD;
            -  Respiratory rate &lt; 10 or &gt; 29 breaths/min&#xD;
  &#xD;
            -  Fall from height &gt; 6 meters&#xD;
  &#xD;
            -  High-Risk Auto Crash: Partial or complete ejection, intrusion &gt; 30 cm any site, Need&#xD;
               for extrication for entrapped patient, Death in passenger compartment&#xD;
  &#xD;
            -  Rider separated from transport vehicle with significant impact&#xD;
  &#xD;
            -  Penetrating injuries to head, neck, torso, and proximal extremities&#xD;
  &#xD;
            -  Skull deformity, suspected skull fracture&#xD;
  &#xD;
            -  Chest wall instability, deformity, or suspected flail chest&#xD;
  &#xD;
            -  Suspected pelvic fracture&#xD;
  &#xD;
            -  Suspected fracture of two or more proximal long bones&#xD;
  &#xD;
            -  Amputation proximal to wrist or ankle&#xD;
  &#xD;
            -  Active bleeding requiring a tourniquet or wound packing with continuous pressure&#xD;
  &#xD;
            -  Burns in conjunction with trauma&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Pregnancy&#xD;
  &#xD;
            -  Patient or family who are unable to obtain informed consent&#xD;
  &#xD;
            -  Known coagulopathy that is inappropriate for arterial line insertion&#xD;
  &#xD;
            -  Known peripheral arterial occlusion disease that is inappropriate for arterial line&#xD;
               insertion&#xD;
  &#xD;
            -  traumatic cardiac arrest&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>An-fu Lee</last_name>
      <phone>+886-5532-3911</phone>
      <phone_ext>563329</phone_ext>
      <email>m040608@hotmail.com.tw</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Ming-tai Cheng</last_name>
      <phone>+886-5532-3911</phone>
      <phone_ext>563329</phone_ext>
      <email>jengmt1976@gmail.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>National Taiwan University Hospital Yunlin Branch</name>
        <address>
          <city>Douliu</city>
          <country>Taiwan</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>An-fu Lee</last_name>
        <email>m040608@hotmail.com.tw</email>
      </contact>
    </location>
    <location_countries>
      <country>Taiwan</country>
    </location_countries>
    <reference>
      <citation>Teixeira PG, Inaba K, Hadjizacharia P, Brown C, Salim A, Rhee P, Browder T, Noguchi TT, Demetriades D. Preventable or potentially preventable mortality at a mature trauma center. J Trauma. 2007 Dec;63(6):1338-46; discussion 1346-7. doi: 10.1097/TA.0b013e31815078ae.</citation>
      <PMID>18212658</PMID>
    </reference>
    <reference>
      <citation>Klauber MR, Marshall LF, Luerssen TG, Frankowski R, Tabaddor K, Eisenberg HM. Determinants of head injury mortality: importance of the low risk patient. Neurosurgery. 1989 Jan;24(1):31-6. doi: 10.1227/00006123-198901000-00005.</citation>
      <PMID>2927596</PMID>
    </reference>
    <reference>
      <citation>Eisenberg HM, Gary HE Jr, Aldrich EF, Saydjari C, Turner B, Foulkes MA, Jane JA, Marmarou A, Marshall LF, Young HF. Initial CT findings in 753 patients with severe head injury. A report from the NIH Traumatic Coma Data Bank. J Neurosurg. 1990 Nov;73(5):688-98. doi: 10.3171/jns.1990.73.5.0688.</citation>
      <PMID>2213158</PMID>
    </reference>
    <reference>
      <citation>Tieu BH, Holcomb JB, Schreiber MA. Coagulopathy: its pathophysiology and treatment in the injured patient. World J Surg. 2007 May;31(5):1055-64. doi: 10.1007/s00268-006-0653-9.</citation>
      <PMID>17426904</PMID>
    </reference>
    <reference>
      <citation>Schreiber MA, Meier EN, Tisherman SA, Kerby JD, Newgard CD, Brasel K, Egan D, Witham W, Williams C, Daya M, Beeson J, McCully BH, Wheeler S, Kannas D, May S, McKnight B, Hoyt DB; ROC Investigators. A controlled resuscitation strategy is feasible and safe in hypotensive trauma patients: results of a prospective randomized pilot trial. J Trauma Acute Care Surg. 2015 Apr;78(4):687-95; discussion 695-7. doi: 10.1097/TA.0000000000000600.</citation>
      <PMID>25807399</PMID>
    </reference>
    <reference>
      <citation>Wijnberge M, van der Ster B, Vlaar APJ, Hollmann MW, Geerts BF, Veelo DP. The Effect of Intermittent versus Continuous Non-Invasive Blood Pressure Monitoring on the Detection of Intraoperative Hypotension, a Sub-Study. J Clin Med. 2022 Jul 14;11(14):4083. doi: 10.3390/jcm11144083.</citation>
      <PMID>35887844</PMID>
    </reference>
    <verification_date>December 2022</verification_date>
    <study_first_submitted>August 3, 2023</study_first_submitted>
    <study_first_submitted_qc>August 10, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 16, 2023</study_first_posted>
    <last_update_submitted>August 10, 2023</last_update_submitted>
    <last_update_submitted_qc>August 10, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 16, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>major trauma</keyword>
    <keyword>arterial line</keyword>
    <keyword>resuscitation</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>
  
  
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/NCT05996068
  org study id: 202210095DINC
  nct id: NCT05996068
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Accident-related deaths is the 7th leading cause of death in Taiwan, and most of them is due
        to trauma from falls and traffic accident. Among trauma patients, the common cause of death
        is from hemorrhagic shock. Thus, real-time and accurate blood pressure monitoring is
        important for trauma patients. Incorrect blood pressure monitoring can lead to adverse events
        like traumatic cardiac arrest and shock and can also delay the time for intervention (fluid
        resuscitation, blood transfusion and operation). The current practice of blood pressure
        monitoring in trauma patient is by non-invasive blood pressure monitoring, which may be
        incorrect and not timely. Patient's body type and peripheral perfusion can both influence the
        result of non-invasive blood pressure monitoring.
  
        With continuous and correct blood pressure monitoring, the resuscitation team can give
        adequate and timely treatment. In some trauma centers, arterial line insertion in trauma
        patients is a daily practice, while the evidence is inadequate and the potential benefit in
        unknown.
  
        The main purpose of this study is to investigate the application of arterial line insertion
        in trauma patients. The study design is a prospective before-after study to exam whether
        arterial line insertion in trauma patients can reduce adverse event rate like hypovolemic
        shock and improve patient's outcomes.
  allocation: Non-Randomized
  intervention model: Single Group Assignment
  intervention model description: We use se before-after study type and only the after phase receive intervention. Before phase will retrospectively collect data from patient without arterial line intervention.
  primary purpose: Diagnostic
  masking: None (Open Label)
  measure: composite primary endpoint (including any hypotension, vasopressors usage, any cardiac arrest in ER, Shock index )
  time frame: during ER stay, up to 6 hours
  description: including any hypotension, vasopressors usage, any cardiac arrest in ER, Shock index (HR/SBP)>1
  measure: prolong ICU admission
  time frame: up to 7 days
  description: define as > 6 days of admission
  measure: 30 days mortality rate
  time frame: mortality within 30 days of trauma event
  description: mortality within 30 days of trauma event
  measure: volume of fluid administration
  time frame: during ER stay, up to 6 hours
  description: any type of fluid administration
  measure: units of red blood cell transfusion
  time frame: during ER stay, up to 6 hours
  description: units of red blood cell transfusion
  arm group label: trauma patients with arterial line insertion
  arm group type: Active Comparator
  description: the after phase, actively recruited patients who are eligible for arterial line insertion
  arm group label: trauma patients without arterial line insertion
  arm group type: No Intervention
  description: the before phase, retrospectively data collection from the past
  intervention type: Device
  intervention name: arterial line
  description: insert arterial line for patients who meet major trauma criteria
  arm group label: trauma patients with arterial line insertion
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: An-fu Lee
  phone: +886-5532-3911
  phone ext: 563329
  email: m040608@hotmail.com.tw
  last name: Ming-tai Cheng
  phone: +886-5532-3911
  phone ext: 563329
  email: jengmt1976@gmail.com
  facility: 
  status: Recruiting
  contact: 
  country: Taiwan
  citation: Teixeira PG, Inaba K, Hadjizacharia P, Brown C, Salim A, Rhee P, Browder T, Noguchi TT, Demetriades D. Preventable or potentially preventable mortality at a mature trauma center. J Trauma. 2007 Dec;63(6):1338-46; discussion 1346-7. doi: 10.1097/TA.0b013e31815078ae.
  PMID: 18212658
  citation: Klauber MR, Marshall LF, Luerssen TG, Frankowski R, Tabaddor K, Eisenberg HM. Determinants of head injury mortality: importance of the low risk patient. Neurosurgery. 1989 Jan;24(1):31-6. doi: 10.1227/00006123-198901000-00005.
  PMID: 2927596
  citation: Eisenberg HM, Gary HE Jr, Aldrich EF, Saydjari C, Turner B, Foulkes MA, Jane JA, Marmarou A, Marshall LF, Young HF. Initial CT findings in 753 patients with severe head injury. A report from the NIH Traumatic Coma Data Bank. J Neurosurg. 1990 Nov;73(5):688-98. doi: 10.3171/jns.1990.73.5.0688.
  PMID: 2213158
  citation: Tieu BH, Holcomb JB, Schreiber MA. Coagulopathy: its pathophysiology and treatment in the injured patient. World J Surg. 2007 May;31(5):1055-64. doi: 10.1007/s00268-006-0653-9.
  PMID: 17426904
  citation: Schreiber MA, Meier EN, Tisherman SA, Kerby JD, Newgard CD, Brasel K, Egan D, Witham W, Williams C, Daya M, Beeson J, McCully BH, Wheeler S, Kannas D, May S, McKnight B, Hoyt DB; ROC Investigators. A controlled resuscitation strategy is feasible and safe in hypotensive trauma patients: results of a prospective randomized pilot trial. J Trauma Acute Care Surg. 2015 Apr;78(4):687-95; discussion 695-7. doi: 10.1097/TA.0000000000000600.
  PMID: 25807399
  citation: Wijnberge M, van der Ster B, Vlaar APJ, Hollmann MW, Geerts BF, Veelo DP. The Effect of Intermittent versus Continuous Non-Invasive Blood Pressure Monitoring on the Detection of Intraoperative Hypotension, a Sub-Study. J Clin Med. 2022 Jul 14;11(14):4083. doi: 10.3390/jcm11144083.
  PMID: 35887844
  responsible party type: Sponsor
  mesh term: Wounds and Injuries