<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/NCT04505423</url>
  </required_header>
  <id_info>
    <org_study_id>20-0727</org_study_id>
    <nct_id>NCT04505423</nct_id>
  </id_info>
  <brief_title>Evaluation of Outcomes Related to Cerebrospinal Fluid Drain Placement</brief_title>
  <official_title>Evaluation of Outcomes Related to Cerebrospinal Fluid Drains Placed Either With or Without Fluoroscopic Guidance for Aortic Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of North Carolina, Chapel Hill</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>UNC Medical Alumni</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of North Carolina, Chapel Hill</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>
      The purpose of this study is to compare the rate and severity of complications associated&#xD;
      with CSFD placement either with or without fluoroscopic guidance.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients undergoing thoracoabdominal aortic aneurysm (TAAA) repair are at risk of suffering&#xD;
      devastating spinal cord injury (SCI), rendering them with a permanent neurologic deficit,&#xD;
      paraplegia, or paraparesis. Despite huge success over the last several decades with the&#xD;
      introduction of innovative protective maneuvers, such as the use of cerebrospinal fluid&#xD;
      drains (CSFDs), the rate of these complications remains around 5%. Spinal cord perfusion can&#xD;
      be compromised during aortic surgery and the intrathecal decompression achieved by CSFDs&#xD;
      functions to increase the pressure gradient of blood flow, thereby optimizing spinal cord&#xD;
      perfusion during aortic surgery. There are two methods commonly used to place cerebrospinal&#xD;
      fluid drains: blind placement and with fluoroscopic guidance. Prior to 2016, CSFDs at UNC&#xD;
      hospital were primarily placed without image guidance. However, hospital policy then&#xD;
      transitioned to having all CSFDs placed using fluoroscopic guidance. To the investigators'&#xD;
      knowledge, there are no reported studies directly comparing clinical outcomes of CSFDs placed&#xD;
      by these methods. Given the increased cost and radiation exposure associated with the use of&#xD;
      fluoroscopy, a better understanding of comparative outcomes has great potential clinical&#xD;
      value. Therefore, the investigators propose to compare the rate and severity of complications&#xD;
      associated with CSFD placement either with or without fluoroscopic guidance.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 3, 2020</start_date>
  <completion_date type="Actual">May 1, 2021</completion_date>
  <primary_completion_date type="Actual">May 1, 2021</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>Rate and Severity of Complications Related Associated with CSFD placement</measure>
    <time_frame>From admission to discharge, up to 2 weeks</time_frame>
    <description>The rate and severity of complications associated with CSFD placement with or without fluoroscopic guidance via a chart review. This will be assessed using quantitative methods such as vital signs and lab-work drawn relating to the procedure as well as qualitative variables through clinical notes.</description>
  </primary_outcome>
  <enrollment type="Actual">302</enrollment>
  <condition>Cerebrospinal Fluid Drainage</condition>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Blind CSF Drain Placement</intervention_name>
    <description>CSF Drain placement without fluoroscopic image guidance.</description>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Fluoroscopy-guided Drain Placement</intervention_name>
    <description>CSF Drain placement utilizing fluoroscopic image guidance.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        UNC Hospital System Patients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  CSF drain placed from 2010 to present prior to undergoing aortic surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients under 18 years of age&#xD;
&#xD;
          -  Patients undergoing emergency procedures&#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_official>
    <last_name>Harendra Arora, MD, MBA</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of North Carolina, Chapel Hill</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UNC Chapel Hill</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27514</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Svensson LG, Crawford ES, Hess KR, Coselli JS, Safi HJ. Experience with 1509 patients undergoing thoracoabdominal aortic operations. J Vasc Surg. 1993 Feb;17(2):357-68; discussion 368-70.</citation>
    <PMID>8433431</PMID>
  </reference>
  <reference>
    <citation>Safi HJ, Estrera AL, Miller CC, Huynh TT, Porat EE, Azizzadeh A, Meada R, Goodrick JS. Evolution of risk for neurologic deficit after descending and thoracoabdominal aortic repair. Ann Thorac Surg. 2005 Dec;80(6):2173-9; discussion 2179. doi: 10.1016/j.athoracsur.2005.05.060.</citation>
    <PMID>16305866</PMID>
  </reference>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>August 5, 2020</study_first_submitted>
  <study_first_submitted_qc>August 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 10, 2020</study_first_posted>
  <last_update_submitted>February 23, 2022</last_update_submitted>
  <last_update_submitted_qc>February 23, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 25, 2022</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>Cerebrospinal Fluid Leak</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_time_frame>Data will be shared beginning 9 to 36 months following publication.</ipd_time_frame>
    <ipd_access_criteria>Data will be shared provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.</ipd_access_criteria>
  </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/NCT04505423
org study id: 20-0727
nct id: NCT04505423
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to compare the rate and severity of complications associated
      with CSFD placement either with or without fluoroscopic guidance.
Patients undergoing thoracoabdominal aortic aneurysm (TAAA) repair are at risk of suffering
      devastating spinal cord injury (SCI), rendering them with a permanent neurologic deficit,
      paraplegia, or paraparesis. Despite huge success over the last several decades with the
      introduction of innovative protective maneuvers, such as the use of cerebrospinal fluid
      drains (CSFDs), the rate of these complications remains around 5%. Spinal cord perfusion can
      be compromised during aortic surgery and the intrathecal decompression achieved by CSFDs
      functions to increase the pressure gradient of blood flow, thereby optimizing spinal cord
      perfusion during aortic surgery. There are two methods commonly used to place cerebrospinal
      fluid drains: blind placement and with fluoroscopic guidance. Prior to 2016, CSFDs at UNC
      hospital were primarily placed without image guidance. However, hospital policy then
      transitioned to having all CSFDs placed using fluoroscopic guidance. To the investigators'
      knowledge, there are no reported studies directly comparing clinical outcomes of CSFDs placed
      by these methods. Given the increased cost and radiation exposure associated with the use of
      fluoroscopy, a better understanding of comparative outcomes has great potential clinical
      value. Therefore, the investigators propose to compare the rate and severity of complications
      associated with CSFD placement either with or without fluoroscopic guidance.
observational model: Cohort
time perspective: Retrospective
measure: Rate and Severity of Complications Related Associated with CSFD placement
time frame: From admission to discharge, up to 2 weeks
description: The rate and severity of complications associated with CSFD placement with or without fluoroscopic guidance via a chart review. This will be assessed using quantitative methods such as vital signs and lab-work drawn relating to the procedure as well as qualitative variables through clinical notes.
intervention type: Procedure
intervention name: Blind CSF Drain Placement
description: CSF Drain placement without fluoroscopic image guidance.
intervention type: Procedure
intervention name: Fluoroscopy-guided Drain Placement
description: CSF Drain placement utilizing fluoroscopic image guidance.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Harendra Arora, MD, MBA
role: Principal Investigator
affiliation: University of North Carolina, Chapel Hill
facility: 
country: United States
citation: Svensson LG, Crawford ES, Hess KR, Coselli JS, Safi HJ. Experience with 1509 patients undergoing thoracoabdominal aortic operations. J Vasc Surg. 1993 Feb;17(2):357-68; discussion 368-70.
PMID: 8433431
citation: Safi HJ, Estrera AL, Miller CC, Huynh TT, Porat EE, Azizzadeh A, Meada R, Goodrick JS. Evolution of risk for neurologic deficit after descending and thoracoabdominal aortic repair. Ann Thorac Surg. 2005 Dec;80(6):2173-9; discussion 2179. doi: 10.1016/j.athoracsur.2005.05.060.
PMID: 16305866
responsible party type: Sponsor
mesh term: Cerebrospinal Fluid Leak
sharing ipd: Yes
ipd description: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
ipd info type: Study Protocol
ipd time frame: Data will be shared beginning 9 to 36 months following publication.
ipd access criteria: Data will be shared provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.