<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/NCT04410952</url>
  </required_header>
  <id_info>
    <org_study_id>002</org_study_id>
    <nct_id>NCT04410952</nct_id>
  </id_info>
  <brief_title>Pelvic Binder vs. Pelvic C-clamp for Bleeding Control</brief_title>
  <official_title>Bleeding Control in Type-C Pelvic Ring Fractures Using the Pelvic C-clamp vs. the Pelvic Binder for Emergency Stabilization - a Matched Pair Analysis From the German Pelvic Registry</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>BG Trauma Center Tuebingen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>BG Trauma Center Tuebingen</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>
      Pelvic ring fractures carry a high risk for severe bleeding. Expecially bleeding from the&#xD;
      posterior ring might result in a fatal course. Different types of external emergency&#xD;
      stabilization (EES) are available for the posterior pelvic ring, namely the non-invasive&#xD;
      pelvic binder or the invasive pelvic c-clamp. Which stabilization technique is superior, has&#xD;
      not been investigated yet.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Severe bleeding is the major cause of death in unstable pelvic ring fractures. Therefore, a&#xD;
      quick and efficient emergency stabilization and bleeding control is inevitable. The pelvic&#xD;
      C-clamp and the pelvic binder are efficient tools for temporary bleeding control, especially&#xD;
      for the posterior pelvic ring. However, whether these disadvantages make up for a more&#xD;
      efficient bleeding control, still needs to be discussed in the guidelines of the emergency&#xD;
      management of pelvic ring fractures.&#xD;
&#xD;
      Patients with a type-C pelvic ring fracture were identified from the German Pelvic Registry&#xD;
      (GPR). The patients were divided into three groups of 40 patients: 1. group without emergency&#xD;
      stabilization, 2. group treated with pelvic binder and 3. group treated with pelvic C-clamp.&#xD;
      The patients were matched according to the following parameters: age, gender, initial RR and&#xD;
      HB level. The complication rates and mortality rates were compared between the groups,&#xD;
      especially regarding bleeding control, as measured by the amount of transfused blood&#xD;
      products. Furthermore, the subjective efficacy of the treatment was assessed. Finally, the&#xD;
      time until established bleeding control was compared.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 7, 2020</start_date>
  <completion_date type="Actual">May 15, 2020</completion_date>
  <primary_completion_date type="Actual">April 30, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Need for transfusion</measure>
    <time_frame>24 hours</time_frame>
    <description>Number of transfused units of packed red blood cells</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Time until emergency stabilization</measure>
    <time_frame>6 hours</time_frame>
    <description>The time until emergency stabilization device is placed in minutes</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mortality rate</measure>
    <time_frame>6 months</time_frame>
    <description>The rate of deaths due to fatal bleeding</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of hospital stay</measure>
    <time_frame>6 months</time_frame>
    <description>Duration of the inpatient treatment in days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complication rate</measure>
    <time_frame>6 months</time_frame>
    <description>The rate of overall complications</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">120</enrollment>
  <condition>Pelvic Ring Fracture</condition>
  <condition>Pelvic Bleeding</condition>
  <condition>Polytrauma</condition>
  <arm_group>
    <arm_group_label>no EES</arm_group_label>
    <description>Patients with a Type-C pelvic ring fracture who underwent no external emergency stabilization (EES) for the posterior pelvic ring</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Pelvic binder</arm_group_label>
    <description>Patients with a Type-C pelvic ring fracture who received a pelvic binder for emergency stabilization of the posterior pelvic ring</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Pelvic C-clamp</arm_group_label>
    <description>Patients with a Type-C pelvic ring fracture who received a pelvic C-clamp for emergency stabilization of the posterior pelvic ring</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with a Type-C pelvic ring fracture and an abdominal ISS &gt;8 are identified from the&#xD;
        German Pelvic Registry.&#xD;
&#xD;
        Cases in which the external emergency stabilization was not specified were left included.&#xD;
        The remaining cases were divided into the different treatment groups:&#xD;
&#xD;
          1. Patients who received no external emergency stabilization.&#xD;
&#xD;
          2. Patients who were treated with a pelvic binder.&#xD;
&#xD;
          3. Patients who were treated with a C-clamp.&#xD;
&#xD;
        Age, gender, the initial HB level and the initial blood pressure were used to match the&#xD;
        cases of the three groups.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Written informed consent for data acquisition in the German Pelvic Registry&#xD;
&#xD;
          -  Pelvic ring fracture Type C (AO/OTA)&#xD;
&#xD;
          -  ISS (Abdomen) &gt;8&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Acetabular fracture&#xD;
&#xD;
          -  Pelvic ring fracture Type A/B (AO/OTA)&#xD;
&#xD;
          -  ISS (Abdomen) &lt;9&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Markus A. Küper, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>BG Trauma Center Tübingen</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>BG Trauma Center</name>
      <address>
        <city>Tübingen</city>
        <zip>72076</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>May 28, 2020</study_first_submitted>
  <study_first_submitted_qc>May 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 1, 2020</study_first_posted>
  <last_update_submitted>June 5, 2020</last_update_submitted>
  <last_update_submitted_qc>June 5, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>BG Trauma Center Tuebingen</investigator_affiliation>
    <investigator_full_name>Markus Küper</investigator_full_name>
    <investigator_title>PD Dr. med.</investigator_title>
  </responsible_party>
  <keyword>Pelvic binder</keyword>
  <keyword>Pelvic C-clamp</keyword>
  <keyword>Pelvic ring fracture</keyword>
  <keyword>Fatal pelvic bleeging</keyword>
  <keyword>Emergency stabilization</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hemorrhage</mesh_term>
    <mesh_term>Fractures, Bone</mesh_term>
    <mesh_term>Multiple Trauma</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
  </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/NCT04410952
org study id: 002
nct id: NCT04410952
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Pelvic ring fractures carry a high risk for severe bleeding. Expecially bleeding from the
      posterior ring might result in a fatal course. Different types of external emergency
      stabilization (EES) are available for the posterior pelvic ring, namely the non-invasive
      pelvic binder or the invasive pelvic c-clamp. Which stabilization technique is superior, has
      not been investigated yet.
Severe bleeding is the major cause of death in unstable pelvic ring fractures. Therefore, a
      quick and efficient emergency stabilization and bleeding control is inevitable. The pelvic
      C-clamp and the pelvic binder are efficient tools for temporary bleeding control, especially
      for the posterior pelvic ring. However, whether these disadvantages make up for a more
      efficient bleeding control, still needs to be discussed in the guidelines of the emergency
      management of pelvic ring fractures.

      Patients with a type-C pelvic ring fracture were identified from the German Pelvic Registry
      (GPR). The patients were divided into three groups of 40 patients: 1. group without emergency
      stabilization, 2. group treated with pelvic binder and 3. group treated with pelvic C-clamp.
      The patients were matched according to the following parameters: age, gender, initial RR and
      HB level. The complication rates and mortality rates were compared between the groups,
      especially regarding bleeding control, as measured by the amount of transfused blood
      products. Furthermore, the subjective efficacy of the treatment was assessed. Finally, the
      time until established bleeding control was compared.
observational model: Cohort
time perspective: Retrospective
measure: Need for transfusion
time frame: 24 hours
description: Number of transfused units of packed red blood cells
measure: Time until emergency stabilization
time frame: 6 hours
description: The time until emergency stabilization device is placed in minutes
measure: Mortality rate
time frame: 6 months
description: The rate of deaths due to fatal bleeding
measure: Length of hospital stay
time frame: 6 months
description: Duration of the inpatient treatment in days
measure: Complication rate
time frame: 6 months
description: The rate of overall complications
arm group label: no EES
description: Patients with a Type-C pelvic ring fracture who underwent no external emergency stabilization (EES) for the posterior pelvic ring
arm group label: Pelvic binder
description: Patients with a Type-C pelvic ring fracture who received a pelvic binder for emergency stabilization of the posterior pelvic ring
arm group label: Pelvic C-clamp
description: Patients with a Type-C pelvic ring fracture who received a pelvic C-clamp for emergency stabilization of the posterior pelvic ring
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Markus A. Küper, MD
role: Principal Investigator
affiliation: BG Trauma Center Tübingen
facility: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: BG Trauma Center Tuebingen
investigator full name: Markus Küper
investigator title: PD Dr. med.
mesh term: Hemorrhage
mesh term: Fractures, Bone
mesh term: Multiple Trauma
sharing ipd: Yes
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)