<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/NCT03286985</url>
  </required_header>
  <id_info>
    <org_study_id>236/60</org_study_id>
    <nct_id>NCT03286985</nct_id>
  </id_info>
  <brief_title>The Prevalence and Incidence of DVT in General ICU</brief_title>
  <acronym>preTIME</acronym>
  <official_title>The Prevalence and Incidence of Deep Venous Thrombosis in General ICU Patients Receiving Enoxaparine Prophylaxis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Masaryk Hospital Krajská zdravotní a.s.</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Masaryk Hospital Krajská zdravotní a.s.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Deep venous thrombosis (DVT) represents a major problem in intensive care unit (ICU)&#xD;
      patients. Despite the use of recommended pharmacological prophylaxis with low molecular&#xD;
      weight heparin (LMWH), the incidence of DVT during ICU stay has been reported between 5 and&#xD;
      15 %. The incidence may vary due to many factors, for example the type of ICU population, the&#xD;
      type of protocol of pharmacological prophylaxis and also the type of diagnostic approach.&#xD;
      Before formerly planned clinical study targeted to lower DVT incidence by individualizing the&#xD;
      dose of LMWH, the investigators decided to evaluate the real DVT incidence in the&#xD;
      investigated ICU. The prevalence and incidence will be assessed by ultrasound testing in&#xD;
      general ICU patients. on the sample of 200 patients. The investigators hypothesize DVT&#xD;
      incidence of 5 %. The compliance to the local DVT prophylaxis protocol will be also&#xD;
      evaluated.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Type of the study: Observational prospective cohort study. Hypothesis: Despite appropriate&#xD;
      prophylaxis of deep venous thrombosis in general ICU patients in accordance with the current&#xD;
      guidelines, the incidence of deep venous thrombosis is 5 - 10%.&#xD;
&#xD;
      Sample size: 200 consecutive general ICU patients. Inclusion and exclusion criteria: defined&#xD;
      in the Eligibility section. Protocol description: All patients admitted to ICU with expected&#xD;
      period of the stay longer than 72 hours will be evaluated for the presence of deep venous&#xD;
      thrombosis by ultrasound testing during the first 48 hours of ICU stay. Thereafter, each&#xD;
      participant will be examined by ultrasound testing twice a week until the discharge from ICU.&#xD;
      All patients will receive deep venous thrombosis prophylaxis following the current&#xD;
      guidelines. All patients with positive finding of deep venous thrombosis will be managed in&#xD;
      accordance with the current guidelines.&#xD;
&#xD;
      Ultrasound examination for deep venous thrombosis: Ultrasound compression test at the&#xD;
      following locations: common femoral vein at the groin, deep femoral vein, popliteal vein,&#xD;
      both extremities.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2017</start_date>
  <completion_date type="Actual">December 31, 2017</completion_date>
  <primary_completion_date type="Actual">December 31, 2017</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>Incidence of deep venous thrombosis</measure>
    <time_frame>24 hours from ICU admission to ICU discharge (up to 12 month)</time_frame>
    <description>Number of patients with new onset deep venous thrombosis diagnosed during ICU stay (ie deep venoous thrombosis developed after the first 24 hours of ICU stay)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Prevalence of deep venous thrombosis</measure>
    <time_frame>From ICU admission to ICU discharge (up to 12 month)</time_frame>
    <description>A number of patients with deep venous thrombosis diagnosed anytime during ICU stay (on admission and during ICU stay)</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">200</enrollment>
  <condition>Deep Venous Thrombosis</condition>
  <arm_group>
    <arm_group_label>General ICU patients</arm_group_label>
    <description>No intervention is associated with inclusion to the study (observational study). Included will be all patients admitted to general ICU with ICU stay &gt;72 hours, having deep venous thrombosis prophylaxis appropriate to clinical setting and following the recent guidelines. All study participants will undergo repeated noninvasive ultrasound testing for deep venous thrombosis, which is normal part of the routine care in our ICU.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        General ICU patients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        All general ICU patients meeting exclusion and inclusion criteria.&#xD;
&#xD;
        Inclusion criteria:&#xD;
&#xD;
        1. General ICU patient with expected length of stay more than 72 hours&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Inability to perform ultrasound investigation for deep venous thrombosis (for medical&#xD;
             or technical reasons)&#xD;
&#xD;
          2. ICU stay shorter than 72 hours&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jan Beneš, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Anesthesiology, Perioperative Medicine and Intensive Care, J.E. Purkinje University, Masaryk Hospital in Usti nad Labem, Usti nad Labem, Czech Republic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Masaryk Hospital</name>
      <address>
        <city>Ústí nad Labem</city>
        <state>Česká Republika</state>
        <zip>40011</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Czechia</country>
  </location_countries>
  <results_reference>
    <citation>Qaseem A, Chou R, Humphrey LL, Starkey M, Shekelle P; Clinical Guidelines Committee of the American College of Physicians. Venous thromboembolism prophylaxis in hospitalized patients: a clinical practice guideline from the American College of Physicians. Ann Intern Med. 2011 Nov 1;155(9):625-32. doi: 10.7326/0003-4819-155-9-201111010-00011.</citation>
    <PMID>22041951</PMID>
  </results_reference>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>May 10, 2016</study_first_submitted>
  <study_first_submitted_qc>September 16, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 19, 2017</study_first_posted>
  <last_update_submitted>October 16, 2020</last_update_submitted>
  <last_update_submitted_qc>October 16, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 19, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Masaryk Hospital Krajská zdravotní a.s.</investigator_affiliation>
    <investigator_full_name>Jan Benes</investigator_full_name>
    <investigator_title>MUDr. Ing.</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Thrombosis</mesh_term>
    <mesh_term>Venous Thrombosis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </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/NCT03286985
org study id: 236/60
nct id: NCT03286985
lead sponsor: 
has dmc: No
Deep venous thrombosis (DVT) represents a major problem in intensive care unit (ICU)
      patients. Despite the use of recommended pharmacological prophylaxis with low molecular
      weight heparin (LMWH), the incidence of DVT during ICU stay has been reported between 5 and
      15 %. The incidence may vary due to many factors, for example the type of ICU population, the
      type of protocol of pharmacological prophylaxis and also the type of diagnostic approach.
      Before formerly planned clinical study targeted to lower DVT incidence by individualizing the
      dose of LMWH, the investigators decided to evaluate the real DVT incidence in the
      investigated ICU. The prevalence and incidence will be assessed by ultrasound testing in
      general ICU patients. on the sample of 200 patients. The investigators hypothesize DVT
      incidence of 5 %. The compliance to the local DVT prophylaxis protocol will be also
      evaluated.
Type of the study: Observational prospective cohort study. Hypothesis: Despite appropriate
      prophylaxis of deep venous thrombosis in general ICU patients in accordance with the current
      guidelines, the incidence of deep venous thrombosis is 5 - 10%.

      Sample size: 200 consecutive general ICU patients. Inclusion and exclusion criteria: defined
      in the Eligibility section. Protocol description: All patients admitted to ICU with expected
      period of the stay longer than 72 hours will be evaluated for the presence of deep venous
      thrombosis by ultrasound testing during the first 48 hours of ICU stay. Thereafter, each
      participant will be examined by ultrasound testing twice a week until the discharge from ICU.
      All patients will receive deep venous thrombosis prophylaxis following the current
      guidelines. All patients with positive finding of deep venous thrombosis will be managed in
      accordance with the current guidelines.

      Ultrasound examination for deep venous thrombosis: Ultrasound compression test at the
      following locations: common femoral vein at the groin, deep femoral vein, popliteal vein,
      both extremities.
observational model: Cohort
time perspective: Prospective
measure: Incidence of deep venous thrombosis
time frame: 24 hours from ICU admission to ICU discharge (up to 12 month)
description: Number of patients with new onset deep venous thrombosis diagnosed during ICU stay (ie deep venoous thrombosis developed after the first 24 hours of ICU stay)
measure: Prevalence of deep venous thrombosis
time frame: From ICU admission to ICU discharge (up to 12 month)
description: A number of patients with deep venous thrombosis diagnosed anytime during ICU stay (on admission and during ICU stay)
arm group label: General ICU patients
description: No intervention is associated with inclusion to the study (observational study). Included will be all patients admitted to general ICU with ICU stay >72 hours, having deep venous thrombosis prophylaxis appropriate to clinical setting and following the recent guidelines. All study participants will undergo repeated noninvasive ultrasound testing for deep venous thrombosis, which is normal part of the routine care in our ICU.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Jan Beneš, MD
role: Principal Investigator
affiliation: Department of Anesthesiology, Perioperative Medicine and Intensive Care, J.E. Purkinje University, Masaryk Hospital in Usti nad Labem, Usti nad Labem, Czech Republic
facility: 
country: Czechia
citation: Qaseem A, Chou R, Humphrey LL, Starkey M, Shekelle P; Clinical Guidelines Committee of the American College of Physicians. Venous thromboembolism prophylaxis in hospitalized patients: a clinical practice guideline from the American College of Physicians. Ann Intern Med. 2011 Nov 1;155(9):625-32. doi: 10.7326/0003-4819-155-9-201111010-00011.
PMID: 22041951
responsible party type: Principal Investigator
investigator affiliation: Masaryk Hospital Krajská zdravotní a.s.
investigator full name: Jan Benes
investigator title: MUDr. Ing.
mesh term: Thrombosis
mesh term: Venous Thrombosis
sharing ipd: Undecided