<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/NCT03253952</url>
  </required_header>
  <id_info>
    <org_study_id>2016H0369</org_study_id>
    <nct_id>NCT03253952</nct_id>
  </id_info>
  <brief_title>A Study of Autonomic Dynamic Dysfunction to Predict Infections After Spinal Cord Injury.</brief_title>
  <official_title>PROSPECT ADDITION SCI - A PROSPECTive Study of Autonomic Dynamic Dysfunction to Predict infecTIONs After Spinal Cord Injury</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ohio State University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ohio State University</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 study is designed to investigate whether autonomic shifts (dysautonomia, sympatho-vagal&#xD;
      instability) that develop after SCI have value in predicting SCI-associated infections&#xD;
      (SCI-AI). SCI-AI impair outcomes by (1) reducing the intrinsic neurological recovery&#xD;
      potential and (2) increasing mortality. Heart Rate Variability (HRV) data will be tracked in&#xD;
      both the time and frequency domains to discriminate between the relative contribution of&#xD;
      sympathetic and parasympathetic innervation to changes in HRV. The ability to predict&#xD;
      infections will enable novel treatments thereby reducing infection-associated mortality and&#xD;
      improving neurological and functional outcomes.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">September 29, 2017</start_date>
  <completion_date type="Anticipated">December 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">September 30, 2022</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Sympatho-vagal instability as an identifier for patients at risk for Spinal Cord Injury Associated Infections</measure>
    <time_frame>At all study time-points for a period of 24hours.</time_frame>
    <description>Determining whether discrete signs of loss of autonomic control (dysautonomia), not meeting defined criteria of full-autonomic dysreflexia, also renders patients &quot;at risk&quot; for developing infections.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Trauma, Spinal Cord</condition>
  <condition>SPINAL Fracture</condition>
  <arm_group>
    <arm_group_label>Traumatic Spinal Cord Injury</arm_group_label>
    <description>Observational study - monitoring immune response and heart rate variability</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Traumatic Spine Fracture, Control Group</arm_group_label>
    <description>Observational study - monitoring immune response and heart rate variability acting as a control group.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        SCI patients (n=50 subjects), Isolated Spinal fracture patients (n=10)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients with acute isolated spinal cord injury (AIS A-D) planned for surgical&#xD;
             stabilization and decompression, lesion may include more than 1 segment&#xD;
&#xD;
          2. Patients with acute isolated spinal fracture, lesion may include more than 1 segment&#xD;
&#xD;
          3. Legal age of the patient&#xD;
&#xD;
          4. Documented informed consent of the patient&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Non-traumatic spinal cord injury&#xD;
&#xD;
          2. Concomitant traumatic brain injury (TBI) (definition: i) patient with severe TBI&#xD;
             (Glasgow Coma Scale ≤ 8) and ii) patients with intracranial pressure monitoring&#xD;
             sensors)&#xD;
&#xD;
          3. Neoplasia and/or antineoplastic therapy&#xD;
&#xD;
          4. Pregnancy, lactation&#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>Jan M Schwab, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ohio State University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Nathaniel B Dusseau, II, BS, MS</last_name>
    <phone>614-293-1454</phone>
    <email>nathaniel.dusseau@osumc.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>The Ohio State University Wexner Medical Center</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43210</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nathaniel B. Dusseau, II, BS, MS</last_name>
      <phone>614-293-1454</phone>
      <email>nathaniel.dusseau@osumc.edu</email>
    </contact>
    <contact_backup>
      <last_name>Monica Lichi, MS, MBA, CCRP</last_name>
      <phone>614-293-3802</phone>
      <email>monica.lichi@osumc.edu</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>August 9, 2017</study_first_submitted>
  <study_first_submitted_qc>August 16, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 18, 2017</study_first_posted>
  <last_update_submitted>March 14, 2022</last_update_submitted>
  <last_update_submitted_qc>March 14, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 15, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ohio State University</investigator_affiliation>
    <investigator_full_name>Jan Schwab</investigator_full_name>
    <investigator_title>Director of Spinal Cord Medicine</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Spinal Cord Injuries</mesh_term>
    <mesh_term>Spinal Fractures</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/NCT03253952
org study id: 2016H0369
nct id: NCT03253952
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The study is designed to investigate whether autonomic shifts (dysautonomia, sympatho-vagal
      instability) that develop after SCI have value in predicting SCI-associated infections
      (SCI-AI). SCI-AI impair outcomes by (1) reducing the intrinsic neurological recovery
      potential and (2) increasing mortality. Heart Rate Variability (HRV) data will be tracked in
      both the time and frequency domains to discriminate between the relative contribution of
      sympathetic and parasympathetic innervation to changes in HRV. The ability to predict
      infections will enable novel treatments thereby reducing infection-associated mortality and
      improving neurological and functional outcomes.
observational model: Cohort
time perspective: Prospective
measure: Sympatho-vagal instability as an identifier for patients at risk for Spinal Cord Injury Associated Infections
time frame: At all study time-points for a period of 24hours.
description: Determining whether discrete signs of loss of autonomic control (dysautonomia), not meeting defined criteria of full-autonomic dysreflexia, also renders patients "at risk" for developing infections.
arm group label: Traumatic Spinal Cord Injury
description: Observational study - monitoring immune response and heart rate variability
arm group label: Traumatic Spine Fracture, Control Group
description: Observational study - monitoring immune response and heart rate variability acting as a control group.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jan M Schwab, MD, PhD
role: Principal Investigator
affiliation: Ohio State University
last name: Nathaniel B Dusseau, II, BS, MS
phone: 614-293-1454
email: nathaniel.dusseau@osumc.edu
facility: 
status: Recruiting
contact: 
contact backup: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Ohio State University
investigator full name: Jan Schwab
investigator title: Director of Spinal Cord Medicine
mesh term: Spinal Cord Injuries
mesh term: Spinal Fractures