<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/NCT03786705</url>
  </required_header>
  <id_info>
    <org_study_id>CMRPG8G1301</org_study_id>
    <nct_id>NCT03786705</nct_id>
  </id_info>
  <brief_title>Delta Shock Index in Predicting Massive Transfusion</brief_title>
  <official_title>The Relationship of Delta Shock Index With the Requirement of Blood Transfusion and Clinical Outcome of Adult Trauma Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chang Gung Memorial Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chang Gung Memorial Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background: To determine the performance of delta shock index (ΔSI), a change in shock index&#xD;
      (SI) upon arrival at the emergency room (ER) from that in the field in predicting the need&#xD;
      for massive transfusion (MT) among adult trauma patients with stable blood pressure.&#xD;
&#xD;
      Methods: This study included data from all trauma patients aged 20 years and above who were&#xD;
      hospitalized from January 1, 2009 to December 31, 2016 and was obtained from the registered&#xD;
      trauma database of the hospital. Only patients who were transferred by emergency medical&#xD;
      service from the accident site with a systolic blood pressure ≥ 90 mm Hg at the ER were&#xD;
      included in this study. The 7,957 enrolled trauma patients were divided into 2 groups, those&#xD;
      who had received blood transfusion ≥ 10 U (MT, n = 82) and those who had not (non-MT, n =&#xD;
      7,875). The odds ratios with 95% confidence intervals for associated patient conditions and&#xD;
      the odds of need for MT by a given ΔSI were measured. The plot of specific receiver operating&#xD;
      characteristic (ROC) curves was used to evaluate the best cutoff point that could predict the&#xD;
      patient's probability of receiving MT.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 5, 2018</start_date>
  <completion_date type="Actual">December 20, 2018</completion_date>
  <primary_completion_date type="Actual">December 20, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>in-hospital mortality</measure>
    <time_frame>up to 5 months</time_frame>
    <description>To measure the outcome of patients.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">7957</enrollment>
  <condition>Trauma Patients Received Blood Transfusion ≥ 10 U</condition>
  <condition>Trauma Patients Had Not Received Blood Transfusion ≥ 10 U</condition>
  <arm_group>
    <arm_group_label>Trauma patients' SBP ≥ 90 mm Hg with EMS</arm_group_label>
    <description>Only patients who were transferred by emergency medical service from the accident site with a systolic blood pressure ≥ 90 mm Hg at the ER were included in this study. The enrolled trauma patients divided into 2 groups, those who had received blood transfusion ≥ 10 U (massive transfusion) and those who had not (non-massive transfusion).</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Massive transfusion</intervention_name>
    <description>Trauma patients who had received blood transfusion≥10 U</description>
    <arm_group_label>Trauma patients' SBP ≥ 90 mm Hg with EMS</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Non-Massive Transfusion</intervention_name>
    <description>Trauma patients who had received blood transfusion&lt;10 U</description>
    <arm_group_label>Trauma patients' SBP ≥ 90 mm Hg with EMS</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All hospitalized trauma patients aged 20 years and above from January 1, 2009 to December&#xD;
        31, 2016 from the registered trauma database of the hospital.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients who were transferred by emergency medical service (EMS) from the field of&#xD;
             accident and had a stable blood pressure (SBP ≥ 90 mmHg) at the ER were included&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who were transferred from other hospitals or arrived by private vehicles.&#xD;
&#xD;
          -  Patients who had incomplete data&#xD;
&#xD;
          -  Patients who had an unstable blood pressure (SBP &lt; 90 mmHg) upon arrival at the ER&#xD;
             were also excluded&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Kaohsiung Chang Gung Memorial Hospital</name>
      <address>
        <city>Kaohsiung</city>
        <zip>83301</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 21, 2018</study_first_submitted>
  <study_first_submitted_qc>December 21, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 26, 2018</study_first_posted>
  <last_update_submitted>December 21, 2018</last_update_submitted>
  <last_update_submitted_qc>December 21, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 26, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Wounds and Injuries</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03786705
org study id: CMRPG8G1301
nct id: NCT03786705
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Background: To determine the performance of delta shock index (ΔSI), a change in shock index
      (SI) upon arrival at the emergency room (ER) from that in the field in predicting the need
      for massive transfusion (MT) among adult trauma patients with stable blood pressure.

      Methods: This study included data from all trauma patients aged 20 years and above who were
      hospitalized from January 1, 2009 to December 31, 2016 and was obtained from the registered
      trauma database of the hospital. Only patients who were transferred by emergency medical
      service from the accident site with a systolic blood pressure ≥ 90 mm Hg at the ER were
      included in this study. The 7,957 enrolled trauma patients were divided into 2 groups, those
      who had received blood transfusion ≥ 10 U (MT, n = 82) and those who had not (non-MT, n =
      7,875). The odds ratios with 95% confidence intervals for associated patient conditions and
      the odds of need for MT by a given ΔSI were measured. The plot of specific receiver operating
      characteristic (ROC) curves was used to evaluate the best cutoff point that could predict the
      patient's probability of receiving MT.
observational model: Case-Control
time perspective: Retrospective
measure: in-hospital mortality
time frame: up to 5 months
description: To measure the outcome of patients.
arm group label: Trauma patients' SBP ≥ 90 mm Hg with EMS
description: Only patients who were transferred by emergency medical service from the accident site with a systolic blood pressure ≥ 90 mm Hg at the ER were included in this study. The enrolled trauma patients divided into 2 groups, those who had received blood transfusion ≥ 10 U (massive transfusion) and those who had not (non-massive transfusion).
intervention type: Other
intervention name: Massive transfusion
description: Trauma patients who had received blood transfusion≥10 U
arm group label: Trauma patients' SBP ≥ 90 mm Hg with EMS
intervention type: Other
intervention name: Non-Massive Transfusion
description: Trauma patients who had received blood transfusion<10 U
arm group label: Trauma patients' SBP ≥ 90 mm Hg with EMS
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: 100 Years
healthy volunteers: No
facility: 
country: Taiwan
responsible party type: Sponsor
mesh term: Wounds and Injuries