<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/NCT03273894</url>
  </required_header>
  <id_info>
    <org_study_id>Temperature KDAR 2017</org_study_id>
    <nct_id>NCT03273894</nct_id>
  </id_info>
  <brief_title>Perioperative Management of Temperature in Children and Influence of Hypothermia on Blood Clotting in Children.</brief_title>
  <acronym>Peritemp</acronym>
  <official_title>Perioperative Management of Temperature in Children and Influence of Hypothermia on Blood Clotting in Children.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Brno University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Brno University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Perioperative hypothermia carries high risk of associated complications. In the observational&#xD;
      study, the standard perioperative temperature management will be evaluated and the influence&#xD;
      of the hypothermia on the coagulation system according to routine coagulation testing in&#xD;
      combination with ROTEM will be evaluated.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Perioperative hypothermia is one of the complications of surgical interventions in total or&#xD;
      regional anaesthesia. It is defined as a drop in body core temperature under 36°C. It occurs&#xD;
      as a result of combination of anaesthesia, effecting of central thermoregulation control,&#xD;
      environment temperature (i.e. operating theatre) and unsufficient isolation combined with&#xD;
      patient's unability to actively warm up. As the body temperature drop in patients under&#xD;
      anaesthesia is very frequent, body temperature checks became part of surgical patients care&#xD;
      optimalisation. Furthermore, it is associated with complications, such as higher incidency of&#xD;
      surgical wound infection, elongated healing process, longer time spent in a hospital, cardiac&#xD;
      complications, elongated effect of most of anaesthetics, immunity and blood clotting&#xD;
      disorders. Hypothermia elongates the initial phase of coagulation and results in thrombocytes&#xD;
      malfunction. Normothermia reduces blood loss.&#xD;
&#xD;
      This prospective observative study has two parts. In the first one, investigators will&#xD;
      evaluate the perioperative management of temperature in paediatric patients in Department of&#xD;
      children anaesthesia and intensive care, University hospital Brno, Czech republic, where is&#xD;
      intended to involve 1,000 patients. In the second phase, the patients who, based on the first&#xD;
      phase of the study, would be the most prone to perioperative hypothermia, will be examined&#xD;
      for any change of coagulation parameters related to the hypothermia. Investigators intend to&#xD;
      involve 100 consecutive patients of the original group. The examined parameters are standard&#xD;
      coagulation tests, EXTEM, FIBTEM tests obtained from a rotational thromboelastometry, or&#xD;
      other ROTEM test related to the particular pathology. Investigators will use a standardized&#xD;
      method of fluid management to affect dilutional coagulopathy.&#xD;
&#xD;
      Standard perioperative patient's monitoring - temperature sensor monitoring of body&#xD;
      temperature, ECG, noninvasive blood pressure, oxygen saturation, EtCO2&#xD;
&#xD;
      Temperature management:&#xD;
&#xD;
      - the anaesthetist decides if some warming tools are needed and notes the used ones, which&#xD;
      involve: warmed infusion, heating blanked, air warming system, infusion pipe heater,&#xD;
      increasing of temperature in the operating theatre, covering the patient or another method of&#xD;
      temperature management&#xD;
&#xD;
      Monitored parameters in the first phase:&#xD;
&#xD;
        -  body temperature before the intervention (measured in the office previously), operating&#xD;
           theatre's temperature at the beginning of anaesthesia&#xD;
&#xD;
        -  body temperature during the intervention including the way of measuring, marked each 15&#xD;
           minutes&#xD;
&#xD;
        -  body temperature at the end of the entire intervention, including signs of the patient's&#xD;
           heat discomfort&#xD;
&#xD;
        -  body temperature during resting time in the after-surgery resting room&#xD;
&#xD;
      Monitored parameters in the second phase:&#xD;
&#xD;
        -  monitored parameters in the first phase + following:&#xD;
&#xD;
        -  blood sampling for standard coagulation tests (following initial of general anaesthesia)&#xD;
           + EXTEM, FIBTEM, NATEM. In case of any pathology found here, more relevant test are run.&#xD;
           The test is analysed by anaesthetist or ICU doctor, where the ROTEM machine is.&#xD;
&#xD;
        -  blood sampling for standard coagulation tests (prior to the end of the surgical&#xD;
           intervention) + EXTEM, FIBTEM, NATEM. In case of any pathology found here, more relevant&#xD;
           test are run. The test is analysed by anaesthetist or ICU doctor, where the ROTEM&#xD;
           machine is.&#xD;
&#xD;
        -  if body temperature is below 34°C, two sets of ROTEM tests are run: one at patient's&#xD;
           body temperature, following by another one at a standard temperature (37°C).&#xD;
&#xD;
      Statistic evaluation:&#xD;
&#xD;
        -  demographic - age, sex, type of surgery, duration of surgery, type of anaesthesia&#xD;
&#xD;
        -  changes of core temperature during the perioperative care and influence of used warming&#xD;
           tools, side effects of changes of core temperature&#xD;
&#xD;
        -  laboratory tests - standard coagulation tests and ROTEM - EXTEM, FIBTEM, NATEM test&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 1, 2017</start_date>
  <completion_date type="Actual">February 24, 2023</completion_date>
  <primary_completion_date type="Actual">August 27, 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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Influence of the hypothermia on the coagulation status</measure>
    <time_frame>Perioperatively</time_frame>
    <description>Perioperative temperature management will be evaluated and the blood samples will be tested for possible coagulation abnormalities in patients undergoing surgery in general anesthesia</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Temperature management</measure>
    <time_frame>Perioperatively</time_frame>
    <description>Data will be evaluated and each perioperative temperature management method will be validated for the effectivity</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">102</enrollment>
  <condition>Perioperative Hypothermia</condition>
  <arm_group>
    <arm_group_label>Paediatric patients undergoing surgery in general anesthesia</arm_group_label>
    <description>Paediatric patients undergoing surgery in general anesthesia with the expected duration over 30 minutes</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Coagulation testing</intervention_name>
    <description>body temperature before the intervention&#xD;
body temperature during the intervention including the way of measuring, each 15 minutes&#xD;
body temperature at the end of surgery, signs of the patient's heat discomfort&#xD;
body temperature during resting time in the postanesthesia care&#xD;
standard coagulation tests + EXTEM, FIBTEM - after anesthesia induction&#xD;
blood sampling for standard coagulation tests (prior to the end of the surgical intervention) + EXTEM, FIBTEM.&#xD;
if body temperature is below 34°C, two sets of ROTEM tests are run: one at patient's body temperature, following by another one at a standard temperature (37°C).</description>
    <arm_group_label>Paediatric patients undergoing surgery in general anesthesia</arm_group_label>
    <other_name>Coagulation status</other_name>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood samples will be tested for coagulation abnormalities - routine coagulation tests and&#xD;
      ROTEM&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Paediatric patients undergoing surgery in general anesthesia&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  paediatric patients of age 0 - 18 years (+ 364 days) indicated to a surgical&#xD;
             intervention with expected duration longer than 30 minutes&#xD;
&#xD;
          -  informed consent of the patient's legal representative to blood sampling in order to&#xD;
             run the coagulation tests&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  surgical intervention shorter than 20 minutes for the second phase:&#xD;
&#xD;
          -  disagreement of the patient and their legal representative&#xD;
&#xD;
          -  preexisting blood clotting disorder&#xD;
&#xD;
          -  potential damage on the patient caused by non-indicated blood sampling (newborns with&#xD;
             low, very low or extremely low birth weight)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>19 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Petr Štourač, doc.MD.Ph.D</last_name>
    <role>Study Chair</role>
    <affiliation>Brno University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University hospital Brno</name>
      <address>
        <city>Brno</city>
        <state>Jihomoravská Kraj</state>
        <zip>62500</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Czechia</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>September 4, 2017</study_first_submitted>
  <study_first_submitted_qc>September 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 6, 2017</study_first_posted>
  <last_update_submitted>February 24, 2023</last_update_submitted>
  <last_update_submitted_qc>February 24, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 27, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Brno University Hospital</investigator_affiliation>
    <investigator_full_name>Petr Štourač, MD</investigator_full_name>
    <investigator_title>Doc.MD.Ph.D</investigator_title>
  </responsible_party>
  <keyword>Hypothermia, temperature management</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Thrombosis</mesh_term>
    <mesh_term>Hypothermia</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/NCT03273894
org study id: Temperature KDAR 2017
nct id: NCT03273894
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Perioperative hypothermia carries high risk of associated complications. In the observational
      study, the standard perioperative temperature management will be evaluated and the influence
      of the hypothermia on the coagulation system according to routine coagulation testing in
      combination with ROTEM will be evaluated.
Perioperative hypothermia is one of the complications of surgical interventions in total or
      regional anaesthesia. It is defined as a drop in body core temperature under 36°C. It occurs
      as a result of combination of anaesthesia, effecting of central thermoregulation control,
      environment temperature (i.e. operating theatre) and unsufficient isolation combined with
      patient's unability to actively warm up. As the body temperature drop in patients under
      anaesthesia is very frequent, body temperature checks became part of surgical patients care
      optimalisation. Furthermore, it is associated with complications, such as higher incidency of
      surgical wound infection, elongated healing process, longer time spent in a hospital, cardiac
      complications, elongated effect of most of anaesthetics, immunity and blood clotting
      disorders. Hypothermia elongates the initial phase of coagulation and results in thrombocytes
      malfunction. Normothermia reduces blood loss.

      This prospective observative study has two parts. In the first one, investigators will
      evaluate the perioperative management of temperature in paediatric patients in Department of
      children anaesthesia and intensive care, University hospital Brno, Czech republic, where is
      intended to involve 1,000 patients. In the second phase, the patients who, based on the first
      phase of the study, would be the most prone to perioperative hypothermia, will be examined
      for any change of coagulation parameters related to the hypothermia. Investigators intend to
      involve 100 consecutive patients of the original group. The examined parameters are standard
      coagulation tests, EXTEM, FIBTEM tests obtained from a rotational thromboelastometry, or
      other ROTEM test related to the particular pathology. Investigators will use a standardized
      method of fluid management to affect dilutional coagulopathy.

      Standard perioperative patient's monitoring - temperature sensor monitoring of body
      temperature, ECG, noninvasive blood pressure, oxygen saturation, EtCO2

      Temperature management:

      - the anaesthetist decides if some warming tools are needed and notes the used ones, which
      involve: warmed infusion, heating blanked, air warming system, infusion pipe heater,
      increasing of temperature in the operating theatre, covering the patient or another method of
      temperature management

      Monitored parameters in the first phase:

        -  body temperature before the intervention (measured in the office previously), operating
           theatre's temperature at the beginning of anaesthesia

        -  body temperature during the intervention including the way of measuring, marked each 15
           minutes

        -  body temperature at the end of the entire intervention, including signs of the patient's
           heat discomfort

        -  body temperature during resting time in the after-surgery resting room

      Monitored parameters in the second phase:

        -  monitored parameters in the first phase + following:

        -  blood sampling for standard coagulation tests (following initial of general anaesthesia)
           + EXTEM, FIBTEM, NATEM. In case of any pathology found here, more relevant test are run.
           The test is analysed by anaesthetist or ICU doctor, where the ROTEM machine is.

        -  blood sampling for standard coagulation tests (prior to the end of the surgical
           intervention) + EXTEM, FIBTEM, NATEM. In case of any pathology found here, more relevant
           test are run. The test is analysed by anaesthetist or ICU doctor, where the ROTEM
           machine is.

        -  if body temperature is below 34°C, two sets of ROTEM tests are run: one at patient's
           body temperature, following by another one at a standard temperature (37°C).

      Statistic evaluation:

        -  demographic - age, sex, type of surgery, duration of surgery, type of anaesthesia

        -  changes of core temperature during the perioperative care and influence of used warming
           tools, side effects of changes of core temperature

        -  laboratory tests - standard coagulation tests and ROTEM - EXTEM, FIBTEM, NATEM test
observational model: Cohort
time perspective: Prospective
measure: Influence of the hypothermia on the coagulation status
time frame: Perioperatively
description: Perioperative temperature management will be evaluated and the blood samples will be tested for possible coagulation abnormalities in patients undergoing surgery in general anesthesia
measure: Temperature management
time frame: Perioperatively
description: Data will be evaluated and each perioperative temperature management method will be validated for the effectivity
arm group label: Paediatric patients undergoing surgery in general anesthesia
description: Paediatric patients undergoing surgery in general anesthesia with the expected duration over 30 minutes
intervention type: Diagnostic Test
intervention name: Coagulation testing
description: body temperature before the intervention
body temperature during the intervention including the way of measuring, each 15 minutes
body temperature at the end of surgery, signs of the patient's heat discomfort
body temperature during resting time in the postanesthesia care
standard coagulation tests + EXTEM, FIBTEM - after anesthesia induction
blood sampling for standard coagulation tests (prior to the end of the surgical intervention) + EXTEM, FIBTEM.
if body temperature is below 34°C, two sets of ROTEM tests are run: one at patient's body temperature, following by another one at a standard temperature (37°C).
arm group label: Paediatric patients undergoing surgery in general anesthesia
other name: Coagulation status
Blood samples will be tested for coagulation abnormalities - routine coagulation tests and
      ROTEM
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: 19 Years
healthy volunteers: No
last name: Petr Štourač, doc.MD.Ph.D
role: Study Chair
affiliation: Brno University Hospital
facility: 
country: Czechia
responsible party type: Principal Investigator
investigator affiliation: Brno University Hospital
investigator full name: Petr Štourač, MD
investigator title: Doc.MD.Ph.D
mesh term: Thrombosis
mesh term: Hypothermia
sharing ipd: Undecided