<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/NCT04476342</url>
  </required_header>
  <id_info>
    <org_study_id>2019-044</org_study_id>
    <nct_id>NCT04476342</nct_id>
  </id_info>
  <brief_title>Integration of Minimal Invasive Cardiopulmonary Bypass System and the Research of Its Blood Compatibility</brief_title>
  <acronym>IMICPBS</acronym>
  <official_title>Integration of Minimal Invasive Cardiopulmonary Bypass System and the Research of Its Blood Compatibility</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Second Affiliated Hospital, School of Medicine, Zhejiang University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Second Affiliated Hospital, School of Medicine, Zhejiang University</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>
      Research objective:&#xD;
&#xD;
      (1) To develop a minimally invasive extracorporeal circulation integrated system, and to form&#xD;
      a new product package, the package of the system should include the extracorporeal&#xD;
      circulation off-set supplies for a routine heart operation.(2) To explore the influence of&#xD;
      integrated minimally invasive extracorporeal circulation system on the recent clinical&#xD;
      outcome of patients.(3) To explore the influence of integrated minimally invasive&#xD;
      extracorporeal circulation system on blood dilution of patients.(4) To explore the influence&#xD;
      of integrated minimally invasive extracorporeal circulation system on inflammatory response&#xD;
      in patients.&#xD;
&#xD;
      1) Clinical research methods: A prospective, single-blind, randomized controlled study was&#xD;
      designed. 80 patients should be included.Clinical study grouping: The control group was&#xD;
      conventional cardiopulmonary bypass (CCPB) group, which was equipped with ordinary&#xD;
      oxygenator, microemboli filter and 4:1 cardioplegia solution.The experimental group was&#xD;
      minimal invasive cardiopulmonary bypass (MICPB) group, with built-in micro-thrombotic&#xD;
      oxygenator and mini cardioplegia (MP) formula (15ML15% potassium chloride (KCl)+10ml compound&#xD;
      potassium, calcium and magnesium +25ml normal saline).&#xD;
&#xD;
      Research method:&#xD;
&#xD;
      A: Before, in, and after cardiopulmonary bypass (CPB) blood collection, Hemoglobin (Hb),&#xD;
      hematokrit (Hct), and blood lactate values of the two groups of patients were measured and&#xD;
      analyzed statistically.B: Blood transfusion volume, urine volume and ultrafiltration volume&#xD;
      were collected during CPB in the two groups of patients, and the data of the two groups were&#xD;
      statistically analyzed.To investigate the effects of integrated minimally invasive&#xD;
      extracorporeal circulation system on inflammatory response indicators white blood cell count&#xD;
      (WBC),C-reactive protein (CRP), interleukin-6(IL-6), tumor necrosis factor-a (TNF-a) and C3a&#xD;
      in patients before (T0), CPB (T1) and 2 hours(H) after CPB (T2), blood samples were collected&#xD;
      from the two groups, centrifugated, superfluid was taken, and stored at -80℃.The&#xD;
      concentrations of CRP, IL-6, TNF-a and C3a were determined by ELISA.Statistical analysis was&#xD;
      performed.WBC was measured in blood routine.(3) To investigate the influence of integrated&#xD;
      minimally invasive extracorporeal circulation system on the recent clinical outcome of&#xD;
      patients. The mechanical ventilation time, ICU time, length of hospital stay, and in-hospital&#xD;
      mortality of patients in the two groups were statistically analyzed.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Research objective:&#xD;
&#xD;
      (1) To develop a minimally invasive extracorporeal circulation integrated system, and to form&#xD;
      a new product package, the package of the system should include the extracorporeal&#xD;
      circulation off-set supplies for a routine heart operation.(2) To explore the influence of&#xD;
      integrated minimally invasive extracorporeal circulation system on the recent clinical&#xD;
      outcome of patients.(3) To explore the influence of integrated minimally invasive&#xD;
      extracorporeal circulation system on blood dilution of patients.(4) To explore the influence&#xD;
      of integrated minimally invasive extracorporeal circulation system on inflammatory response&#xD;
      in patients.&#xD;
&#xD;
      Research and development of integrated minimally invasive extracorporeal circulation system&#xD;
&#xD;
      (1) Appropriate CPB tubes should be determined according to clinical needs. Adopt 3/8 inch&#xD;
      vein tubes and elevate the position of blood storage tank to reduce the length of the tubes&#xD;
      and precharge.The piping jacket shall include the main pump pipe, the infusion pipe, the&#xD;
      platform package (static and static vessels), the left and right core suction pipe, and the&#xD;
      negative pressure suction pipe.The total precharge should be kept at about 800ml (284ml&#xD;
      static precharge of the self-equipped micro-plug oxygenator, and about 500ml precharge of the&#xD;
      pipeline and stopping liquid perfusion system).(2) Cooperate with integrated membrane&#xD;
      oxygenator manufacturers in the design of pipelines to form a wrapper that integrates&#xD;
      membrane oxygenator and pipeline.Among them, oxygenator and pipeline should be well connected&#xD;
      in the sheath.&#xD;
&#xD;
      Clinical research methods:&#xD;
&#xD;
      A prospective, single-blind, randomized controlled study was designed. 80 patients should be&#xD;
      included.Clinical study grouping: The control group was CCPB group, which was equipped with&#xD;
      ordinary oxygenator, microemboli filter and 4:1 cardioplegia solution.The experimental group&#xD;
      was MICPB group, with built-in micro-thrombotic oxygenator and MP formula (15ML15% KCl+10ml&#xD;
      compound potassium, calcium and magnesium +25ml normal saline).&#xD;
&#xD;
      Research method:&#xD;
&#xD;
      A: Before, in, and after CPB blood collection, Hb, Hct, and blood lactate values of the two&#xD;
      groups of patients were measured and analyzed statistically.B: Blood transfusion volume,&#xD;
      urine volume and ultrafiltration volume were collected during CPB in the two groups of&#xD;
      patients, and the data of the two groups were statistically analyzed.To investigate the&#xD;
      effects of integrated minimally invasive extracorporeal circulation system on inflammatory&#xD;
      response indicators WBC, CRP, IL-6, TNF- and C3a in patients before (T0), CPB (T1) and 2&#xD;
      hours after CPB (T2), blood samples were collected from the two groups, centrifugated,&#xD;
      superfluid was taken, and stored at -80℃.The concentrations of CRP, IL-6, TNF- and C3a were&#xD;
      determined by ELISA.Statistical analysis was performed.WBC was measured in blood routine.(3)&#xD;
      To investigate the influence of integrated minimally invasive extracorporeal circulation&#xD;
      system on the recent clinical outcome of patients. The mechanical ventilation time, ICU time,&#xD;
      length of hospital stay, and in-hospital mortality of patients in the two groups were&#xD;
      statistically analyzed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 1, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2020</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>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Blood transfusion volume</measure>
    <time_frame>through surgery completion, an average of 5 hours</time_frame>
    <description>Blood transfusion volume during cardiac surgery</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>ICU duration</measure>
    <time_frame>Duration of ICU stay, an average of 3 days</time_frame>
    <description>Duration of ICU Stay</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Cardiopulmonary Bypass</condition>
  <condition>Cardiac Surgery</condition>
  <arm_group>
    <arm_group_label>MICPB group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The experimental group is minimal invasive cardiopulmonary bypass (MICPB) group, with built-in micro-thrombotic oxygenator and mini cardioplegia (MP) formula (15ML15% KCl+10ml compound potassium, calcium and magnesium +25ml normal saline).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CCPB group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The control group was conventional cardiopulmonary bypass (CCPB) group, using ordinary oxygenator, microemboli filter, and 4:1 cardioplegia solution.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>minimal invasive cardiopulmonary bypass (MICPB) system</intervention_name>
    <description>The experimental group was MICPB group, with built-in micro-thrombotic oxygenator and MP formula (15mL 15%KCl+10ml compound potassium, calcium and magnesium +25ml normal saline)</description>
    <arm_group_label>MICPB group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient weight ≤60kg;&#xD;
&#xD;
          -  Age ≥18 years old;&#xD;
&#xD;
          -  The patient underwent cardiac arrest surgery.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Heart transplant patients;&#xD;
&#xD;
          -  Emergency cardiac surgery patients;&#xD;
&#xD;
          -  Patients who had been assisted by extracorporeal membrane oxygenator (ECMO) or&#xD;
             assisted by left heart before operation&#xD;
&#xD;
          -  Left ventricular ejection fraction (LVEF) &lt; 30%;&#xD;
&#xD;
          -  Patients with coagulation dysfunction before surgery;&#xD;
&#xD;
          -  Patients with preoperative hepatic and renal insufficiency;&#xD;
&#xD;
          -  Recent cerebrovascular accident patients.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Anqi Li, master</last_name>
    <phone>86-13706719453</phone>
    <email>13706719453@163.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Second Affiliated Hospital, School of Medicine, Zhejiang University</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>310009</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Anqi Li, master</last_name>
      <phone>86-13706719453</phone>
      <email>13706719453@163.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 28, 2020</study_first_submitted>
  <study_first_submitted_qc>July 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 20, 2020</study_first_posted>
  <last_update_submitted>July 16, 2020</last_update_submitted>
  <last_update_submitted_qc>July 16, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 20, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>cardiopulmonary bypass</keyword>
  <keyword>minimal invasive</keyword>
  <keyword>cardiac surgery</keyword>
  <keyword>blood compatibility</keyword>
  <patient_data>
    <sharing_ipd>No</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/NCT04476342
org study id: 2019-044
nct id: NCT04476342
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Research objective:

      (1) To develop a minimally invasive extracorporeal circulation integrated system, and to form
      a new product package, the package of the system should include the extracorporeal
      circulation off-set supplies for a routine heart operation.(2) To explore the influence of
      integrated minimally invasive extracorporeal circulation system on the recent clinical
      outcome of patients.(3) To explore the influence of integrated minimally invasive
      extracorporeal circulation system on blood dilution of patients.(4) To explore the influence
      of integrated minimally invasive extracorporeal circulation system on inflammatory response
      in patients.

      1) Clinical research methods: A prospective, single-blind, randomized controlled study was
      designed. 80 patients should be included.Clinical study grouping: The control group was
      conventional cardiopulmonary bypass (CCPB) group, which was equipped with ordinary
      oxygenator, microemboli filter and 4:1 cardioplegia solution.The experimental group was
      minimal invasive cardiopulmonary bypass (MICPB) group, with built-in micro-thrombotic
      oxygenator and mini cardioplegia (MP) formula (15ML15% potassium chloride (KCl)+10ml compound
      potassium, calcium and magnesium +25ml normal saline).

      Research method:

      A: Before, in, and after cardiopulmonary bypass (CPB) blood collection, Hemoglobin (Hb),
      hematokrit (Hct), and blood lactate values of the two groups of patients were measured and
      analyzed statistically.B: Blood transfusion volume, urine volume and ultrafiltration volume
      were collected during CPB in the two groups of patients, and the data of the two groups were
      statistically analyzed.To investigate the effects of integrated minimally invasive
      extracorporeal circulation system on inflammatory response indicators white blood cell count
      (WBC),C-reactive protein (CRP), interleukin-6(IL-6), tumor necrosis factor-a (TNF-a) and C3a
      in patients before (T0), CPB (T1) and 2 hours(H) after CPB (T2), blood samples were collected
      from the two groups, centrifugated, superfluid was taken, and stored at -80℃.The
      concentrations of CRP, IL-6, TNF-a and C3a were determined by ELISA.Statistical analysis was
      performed.WBC was measured in blood routine.(3) To investigate the influence of integrated
      minimally invasive extracorporeal circulation system on the recent clinical outcome of
      patients. The mechanical ventilation time, ICU time, length of hospital stay, and in-hospital
      mortality of patients in the two groups were statistically analyzed.
Research objective:

      (1) To develop a minimally invasive extracorporeal circulation integrated system, and to form
      a new product package, the package of the system should include the extracorporeal
      circulation off-set supplies for a routine heart operation.(2) To explore the influence of
      integrated minimally invasive extracorporeal circulation system on the recent clinical
      outcome of patients.(3) To explore the influence of integrated minimally invasive
      extracorporeal circulation system on blood dilution of patients.(4) To explore the influence
      of integrated minimally invasive extracorporeal circulation system on inflammatory response
      in patients.

      Research and development of integrated minimally invasive extracorporeal circulation system

      (1) Appropriate CPB tubes should be determined according to clinical needs. Adopt 3/8 inch
      vein tubes and elevate the position of blood storage tank to reduce the length of the tubes
      and precharge.The piping jacket shall include the main pump pipe, the infusion pipe, the
      platform package (static and static vessels), the left and right core suction pipe, and the
      negative pressure suction pipe.The total precharge should be kept at about 800ml (284ml
      static precharge of the self-equipped micro-plug oxygenator, and about 500ml precharge of the
      pipeline and stopping liquid perfusion system).(2) Cooperate with integrated membrane
      oxygenator manufacturers in the design of pipelines to form a wrapper that integrates
      membrane oxygenator and pipeline.Among them, oxygenator and pipeline should be well connected
      in the sheath.

      Clinical research methods:

      A prospective, single-blind, randomized controlled study was designed. 80 patients should be
      included.Clinical study grouping: The control group was CCPB group, which was equipped with
      ordinary oxygenator, microemboli filter and 4:1 cardioplegia solution.The experimental group
      was MICPB group, with built-in micro-thrombotic oxygenator and MP formula (15ML15% KCl+10ml
      compound potassium, calcium and magnesium +25ml normal saline).

      Research method:

      A: Before, in, and after CPB blood collection, Hb, Hct, and blood lactate values of the two
      groups of patients were measured and analyzed statistically.B: Blood transfusion volume,
      urine volume and ultrafiltration volume were collected during CPB in the two groups of
      patients, and the data of the two groups were statistically analyzed.To investigate the
      effects of integrated minimally invasive extracorporeal circulation system on inflammatory
      response indicators WBC, CRP, IL-6, TNF- and C3a in patients before (T0), CPB (T1) and 2
      hours after CPB (T2), blood samples were collected from the two groups, centrifugated,
      superfluid was taken, and stored at -80℃.The concentrations of CRP, IL-6, TNF- and C3a were
      determined by ELISA.Statistical analysis was performed.WBC was measured in blood routine.(3)
      To investigate the influence of integrated minimally invasive extracorporeal circulation
      system on the recent clinical outcome of patients. The mechanical ventilation time, ICU time,
      length of hospital stay, and in-hospital mortality of patients in the two groups were
      statistically analyzed.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Blood transfusion volume
time frame: through surgery completion, an average of 5 hours
description: Blood transfusion volume during cardiac surgery
measure: ICU duration
time frame: Duration of ICU stay, an average of 3 days
description: Duration of ICU Stay
arm group label: MICPB group
arm group type: Experimental
description: The experimental group is minimal invasive cardiopulmonary bypass (MICPB) group, with built-in micro-thrombotic oxygenator and mini cardioplegia (MP) formula (15ML15% KCl+10ml compound potassium, calcium and magnesium +25ml normal saline).
arm group label: CCPB group
arm group type: No Intervention
description: The control group was conventional cardiopulmonary bypass (CCPB) group, using ordinary oxygenator, microemboli filter, and 4:1 cardioplegia solution.
intervention type: Device
intervention name: minimal invasive cardiopulmonary bypass (MICPB) system
description: The experimental group was MICPB group, with built-in micro-thrombotic oxygenator and MP formula (15mL 15%KCl+10ml compound potassium, calcium and magnesium +25ml normal saline)
arm group label: MICPB group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Anqi Li, master
phone: 86-13706719453
email: 13706719453@163.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor
sharing ipd: No