<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/NCT02214524</url>
  </required_header>
  <id_info>
    <org_study_id>MDI0092</org_study_id>
    <nct_id>NCT02214524</nct_id>
  </id_info>
  <brief_title>Comparison of Active and Passive Perioperative Warming Techniques in Reducing Intraoperative Blood Loss</brief_title>
  <official_title>Comparison of Active Warming System and Conventional Passive Warming Care in Reducing Intraoperative Blood Loss for Patients Undergoing Major Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peking Union Medical College Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>3M</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Peking Union Medical College Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a randomized, open label, parallel two arm, clinical study, which compare the Bair&#xD;
      Hugger forced-air warming blanket and the conventional warming care practice in China on&#xD;
      patients undergoing major surgery to determine the impact of maintaining normothermia on&#xD;
      intraoperative blood loss, requirement for transfusion of packed red blood cells and the&#xD;
      changes of coagulation function.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Each Investigator reviews the most current Instructions for Use for Bair Hugger Forced air&#xD;
      Warming System to assess the contraindications, warnings, and precaution sections with&#xD;
      respect to risks and benefits for treating potential patients.&#xD;
&#xD;
      60 patients will be enrolled preliminary in this clinical trial. Equal size of 30 patients&#xD;
      were allocated randomly into interventional or control group.&#xD;
&#xD;
      Randomization will be performed after the patient has met all eligibility criteria, including&#xD;
      the general inclusion or exclusion and the patient or legally authorized representative has&#xD;
      signed an informed consent form prior to any study related procedure.&#xD;
&#xD;
      Prior to induction, patients in the interventional group were provided 15 to 30 minutes&#xD;
      forced air warming using the Bair Hugger warming unit, either in the pre-anesthesia area or&#xD;
      OR,which may add to the total heat content of the body helping to reduce the effects of&#xD;
      redistribution temperature drop for procedures using a temperature management strategy. The&#xD;
      Bair Hugger warming unit is placed on its highest temperature setting and will be adjusted by&#xD;
      the investigator depending on temperature monitoring. Temperature will be measured in both&#xD;
      groups by either Spot-On sensor and tympanic membrane thermometer.&#xD;
&#xD;
      Statistical analysis will be performed after the data of 30 cases (both groups) were&#xD;
      available and the sample size will be re-estimated based on preliminary data analysis.&#xD;
      Continuous variables will be summarized with mean, median, standard deviation, minimum and&#xD;
      maximum, as applicable. Categorical variables will be summarized with frequency and&#xD;
      percentage. Student t test will be used to compare means for continuous variables. A Chi&#xD;
      square test or a Fisher's exact test will be used to compare proportions for categorical&#xD;
      variables. Multiple regression will be performed to assess the risk ratios of patients&#xD;
      developing hypothermia and will be expressed as an risk ratio along with a 95% confidence&#xD;
      interval.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>August 2014</start_date>
  <completion_date type="Anticipated">January 2015</completion_date>
  <primary_completion_date type="Anticipated">November 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Core Temperature and blood loss</measure>
    <time_frame>intraoperative</time_frame>
    <description>Monitor the changes of core temperature for whole perioperative period and the amount of blood loss were recorded</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Length of Stay in PACU</measure>
    <time_frame>90 days after Hip replacement surgery and 30 days after other surgerys</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of Stay in Hospital</measure>
    <time_frame>90 days after Hip replacement surgery and 30 days after other surgerys</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of Stay in ICU</measure>
    <time_frame>90 days after Hip replacement surgery and 30 days after other surgerys</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Surgical Site Infection（SSI）</measure>
    <time_frame>90 days after Hip replacement surgery and 30 days after other surgerys</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>coagulation function</measure>
    <time_frame>perioperative period</time_frame>
    <description>take blood sample to detect the coagulation function,including Prothrombin time,Active Partial Thromboplastin Time,International normalized Ratio,Thromboelastography,Hemoglobin,ect.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Hypothermia</condition>
  <condition>Blood Loss,</condition>
  <condition>Blood Coagulation Disorders</condition>
  <arm_group>
    <arm_group_label>Bair hugger forced air warming therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Use of Bair Hugger forced-air warming system perioperatively to keep patient normothermia</description>
  </arm_group>
  <arm_group>
    <arm_group_label>conventional warming care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>conventional warming care</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Bair Hugger forced air warming system</intervention_name>
    <description>Bair Hugger Model 775 temperature management unit-offers two airflow settings, hose-end temperature sensing, and precise temperature delivery</description>
    <arm_group_label>Bair hugger forced air warming therapy</arm_group_label>
    <other_name>Bair Hugger 775, 70-2007-6800</other_name>
    <other_name>Bair Hugger Blanket Model 635 and 300</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients≥18 years old&#xD;
&#xD;
          -  Preoperative core temperature between 36.0 and 37.5°C&#xD;
&#xD;
          -  American Society of Anaesthesiologists（ASA） Physical Status Classification System&#xD;
             I-III&#xD;
&#xD;
          -  No transdermal meds on the target site&#xD;
&#xD;
          -  Elective major surgeries included but not limited:&#xD;
&#xD;
               -  Hip replacement&#xD;
&#xD;
               -  Thoracic surgery (lobectomy and esophagectomy) or abdominal surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Less than 18 years old&#xD;
&#xD;
          -  Uncontrolled insulin-dependent diabetes mellitus (preoperative glucose &gt;250 mg/dL)&#xD;
&#xD;
          -  A preoperative temperature above 37.5°C or less than 36°C&#xD;
&#xD;
          -  Hyperthyroidism and hypothyroidism&#xD;
&#xD;
          -  Raynaud disease&#xD;
&#xD;
          -  History of infection and fever within 4 weeks before surgery&#xD;
&#xD;
          -  Use of steroid or immunosuppressant within 4 weeks before surgery&#xD;
&#xD;
          -  History of bleeding disorders&#xD;
&#xD;
          -  Clinically significant laboratory abnormalities&#xD;
&#xD;
          -  Hgb ≤ 10.0 g/L&#xD;
&#xD;
          -  Platelets ≤ 100,000 / mL&#xD;
&#xD;
          -  WBC（white blood cell ） &lt;3000/dL&#xD;
&#xD;
          -  Fibrinogen&lt;200 mg/dL&#xD;
&#xD;
          -  Thromboplastin time&gt;40s&#xD;
&#xD;
          -  Prothrombin time&#xD;
&#xD;
          -  international normalized ratio(INR）&lt;70%&#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>Yugung Huang Huang, doctoral</last_name>
    <role>Principal Investigator</role>
    <affiliation>Peking Union Medical College Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Hao Liang</last_name>
    <phone>+86 13391994260</phone>
    <email>805582814@qq.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Ruiyue Song</last_name>
    <phone>+86 13261916376</phone>
    <email>575514878@qq.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Peking Union Medical College Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100000</zip>
        <country>China</country>
      </address>
    </facility>
    <contact>
      <last_name>Jie YI, doctoral</last_name>
      <phone>+86 10 69152025</phone>
      <email>neyil@pumch.cn</email>
    </contact>
    <investigator>
      <last_name>Yuguang Huang, doctoral</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Jie Yi, doctoral</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 8, 2014</study_first_submitted>
  <study_first_submitted_qc>August 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 12, 2014</study_first_posted>
  <last_update_submitted>August 15, 2014</last_update_submitted>
  <last_update_submitted_qc>August 15, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 18, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Peking Union Medical College Hospital</investigator_affiliation>
    <investigator_full_name>Jie YI</investigator_full_name>
    <investigator_title>Vice director</investigator_title>
  </responsible_party>
  <keyword>perioperative hypothermia</keyword>
  <keyword>Tympanic temperature</keyword>
  <keyword>Blood loss</keyword>
  <keyword>Blood Coagulation Disorders</keyword>
  <keyword>Major surgery</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hemostatic Disorders</mesh_term>
    <mesh_term>Blood Coagulation Disorders</mesh_term>
    <mesh_term>Hypothermia</mesh_term>
    <mesh_term>Hemorrhage</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/NCT02214524
org study id: MDI0092
nct id: NCT02214524
lead sponsor: 
collaborator: 
has dmc: Yes
This is a randomized, open label, parallel two arm, clinical study, which compare the Bair
      Hugger forced-air warming blanket and the conventional warming care practice in China on
      patients undergoing major surgery to determine the impact of maintaining normothermia on
      intraoperative blood loss, requirement for transfusion of packed red blood cells and the
      changes of coagulation function.
Each Investigator reviews the most current Instructions for Use for Bair Hugger Forced air
      Warming System to assess the contraindications, warnings, and precaution sections with
      respect to risks and benefits for treating potential patients.

      60 patients will be enrolled preliminary in this clinical trial. Equal size of 30 patients
      were allocated randomly into interventional or control group.

      Randomization will be performed after the patient has met all eligibility criteria, including
      the general inclusion or exclusion and the patient or legally authorized representative has
      signed an informed consent form prior to any study related procedure.

      Prior to induction, patients in the interventional group were provided 15 to 30 minutes
      forced air warming using the Bair Hugger warming unit, either in the pre-anesthesia area or
      OR,which may add to the total heat content of the body helping to reduce the effects of
      redistribution temperature drop for procedures using a temperature management strategy. The
      Bair Hugger warming unit is placed on its highest temperature setting and will be adjusted by
      the investigator depending on temperature monitoring. Temperature will be measured in both
      groups by either Spot-On sensor and tympanic membrane thermometer.

      Statistical analysis will be performed after the data of 30 cases (both groups) were
      available and the sample size will be re-estimated based on preliminary data analysis.
      Continuous variables will be summarized with mean, median, standard deviation, minimum and
      maximum, as applicable. Categorical variables will be summarized with frequency and
      percentage. Student t test will be used to compare means for continuous variables. A Chi
      square test or a Fisher's exact test will be used to compare proportions for categorical
      variables. Multiple regression will be performed to assess the risk ratios of patients
      developing hypothermia and will be expressed as an risk ratio along with a 95% confidence
      interval.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Core Temperature and blood loss
time frame: intraoperative
description: Monitor the changes of core temperature for whole perioperative period and the amount of blood loss were recorded
measure: Length of Stay in PACU
time frame: 90 days after Hip replacement surgery and 30 days after other surgerys
measure: Length of Stay in Hospital
time frame: 90 days after Hip replacement surgery and 30 days after other surgerys
measure: Length of Stay in ICU
time frame: 90 days after Hip replacement surgery and 30 days after other surgerys
measure: Surgical Site Infection（SSI）
time frame: 90 days after Hip replacement surgery and 30 days after other surgerys
measure: coagulation function
time frame: perioperative period
description: take blood sample to detect the coagulation function,including Prothrombin time,Active Partial Thromboplastin Time,International normalized Ratio,Thromboelastography,Hemoglobin,ect.
arm group label: Bair hugger forced air warming therapy
arm group type: Experimental
description: Use of Bair Hugger forced-air warming system perioperatively to keep patient normothermia
arm group label: conventional warming care
arm group type: No Intervention
description: conventional warming care
intervention type: Device
intervention name: Bair Hugger forced air warming system
description: Bair Hugger Model 775 temperature management unit-offers two airflow settings, hose-end temperature sensing, and precise temperature delivery
arm group label: Bair hugger forced air warming therapy
other name: Bair Hugger 775, 70-2007-6800
other name: Bair Hugger Blanket Model 635 and 300
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Yugung Huang Huang, doctoral
role: Principal Investigator
affiliation: Peking Union Medical College Hospital
last name: Hao Liang
phone: +86 13391994260
email: 805582814@qq.com
last name: Ruiyue Song
phone: +86 13261916376
email: 575514878@qq.com
facility: 
contact: 
investigator: 
investigator: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Peking Union Medical College Hospital
investigator full name: Jie YI
investigator title: Vice director
mesh term: Hemostatic Disorders
mesh term: Blood Coagulation Disorders
mesh term: Hypothermia
mesh term: Hemorrhage