<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/NCT02972684</url>
  </required_header>
  <id_info>
    <org_study_id>RC16_0009</org_study_id>
    <nct_id>NCT02972684</nct_id>
  </id_info>
  <brief_title>Cost-Utility Analysis of Management of Peri Operative Haemorrhage Following Cardiac Surgery With Cardiopulmonary Bypass</brief_title>
  <acronym>IMOTEC</acronym>
  <official_title>Cost-Utility Analysis of Management of Peri Operative Haemorrhage Following Cardiac Surgery Using Conventional Blood Coagulation Tests or Thrombo-elastographic Point of Care Test - IMOTEC</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nantes University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ministry of Health, France</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Nantes University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Peri operative haemorrhage following cardio Pulmonary Bypass may occur in 5 to 10% of cardiac&#xD;
      surgical interventions.&#xD;
&#xD;
      Treatment of such complication often necessitates various combinations therapeutic&#xD;
      intervention including allogenic blood products administration, drug use and/or surgical&#xD;
      intervention. All are expensive treatment and decision making is guided by patient clinical&#xD;
      status and biological tests of the haemostatic function.&#xD;
&#xD;
      A key point is the time frame of the clinical process. Therapeutic choices have to be done as&#xD;
      fast as possible to minimize bleeding consequences on patient haemodynamic and physiological&#xD;
      status. Conventional coagulation test results availability time usually exceed 45' after&#xD;
      blood drawing. In such situation, the results may not reflect precisely the coagulation&#xD;
      system current state. This downside is often counterbalanced by clinicians empirical choices&#xD;
      preceding lab test results knowledge that may conduct to inappropriate treatment, blood&#xD;
      product overuse and undue expense.&#xD;
&#xD;
      Viscoelastic point of care test may compensate for the limitations of conventional&#xD;
      coagulation tests. In perioperative haemorrhage, faster and more precise information about&#xD;
      haemostatic function may help for more accurate therapeutic choices.&#xD;
&#xD;
      The IMOTEC study aims to compare haemorrhage management following cardiac surgery using&#xD;
      conventional blood coagulation tests or thrombo-elastogaphic point of care test.&#xD;
&#xD;
      Primary endpoint is a cost utility analysis of the technology and secondary endpoints include&#xD;
      blood component transfusion, postoperative bleeding , thoracic re-intervention, postoperative&#xD;
      infection (any cause), organ failure, in hospital length of stay and death.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The research is a real life, prospective, single blinded stepped wedge randomized study.&#xD;
&#xD;
      Inclusion after informed consent of adult patient having cardio-vascular surgical procedure&#xD;
      using cardiopulmonary bypass and meeting inclusion criterion &quot;bleeding&quot;.&#xD;
&#xD;
      After meeting inclusion criterion patients are managed either using conventional blood&#xD;
      coagulation tests or using thrombo-elastometry POC test and predefined therapeutic&#xD;
      interventions described in a specific algorithm.&#xD;
&#xD;
      Other elements of patient clinical management follow usual center standard care .&#xD;
&#xD;
      Follow up of EQ-5D and clinical evaluations are performed at one , 6 and 12 months after&#xD;
      inclusion.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 3, 2017</start_date>
  <completion_date type="Actual">February 2020</completion_date>
  <primary_completion_date type="Actual">February 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>Diagnostic</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cost-utility ratio</measure>
    <time_frame>one year</time_frame>
    <description>incremental cost per incremental life year and incremental costs per incremental QALY</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>incremental cost effectiveness ratio</measure>
    <time_frame>one year</time_frame>
    <description>incremental cost effectiveness ratio : difference in costs divided by the difference in mortality and serious adverse events</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complication rates</measure>
    <time_frame>one year</time_frame>
    <description>Parameters followed during hospitalization are: volume of postoperative bleeding, allogeneic blood product transfusion, blood cell count, postoperative complications: surgical reexploration, acute kidney injury, need for renal replacement therapy, organ failure, acquired infections, mechanical ventilation duration, intensive care, and in hospital length of stay, death.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complication rates</measure>
    <time_frame>one year</time_frame>
    <description>The major complications that can occur within 12 months are: death, cardio-thoracic surgical intervention, acute kidney injury, need for renal replacement therapy, any serious illness diagnosis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation survey</measure>
    <time_frame>Day 1</time_frame>
    <description>Evaluation survey regarding the context and the parameters that impacted the physician's decision, which will be used a sub-group of 100 patients.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The location of the Thrombo-elastometry POC testing</measure>
    <time_frame>three years</time_frame>
    <description>The location of the Thrombo-elastometry POC testing (operative room or laboratory)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1098</enrollment>
  <condition>C.Surgical Procedure; Cardiac</condition>
  <condition>Blood Transfusion</condition>
  <condition>Blood Coagulation Disorders</condition>
  <condition>Bypass, Cardiopulmonary</condition>
  <condition>Hemostatic</condition>
  <arm_group>
    <arm_group_label>Conventional coagulation management</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>management of perioperative haemorrhage following cardiac surgery using conventional blood coagulation tests.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Thrombo-elastometry POC testing</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>management of perioperative haemorrhage following cardiac surgery using the thrombo-elastometry point of care test.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Thrombo-elastometry POC testing</intervention_name>
    <description>Use of thrombo-elastometry point of care test and algorithm guided predetermined intervention during peri operative haemorrhage</description>
    <arm_group_label>Thrombo-elastometry POC testing</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Pre-Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients over 18 years old scheduled for elective or urgent cardiac surgery&#xD;
             using cardiopulmonary bypass .&#xD;
&#xD;
          -  Patient informed written consent (non-opposition to data use) or person of trust or&#xD;
             family member information .&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
        Blood Coagulation test sampling indication for intra or post-operative bleeding defined as&#xD;
        follow:&#xD;
&#xD;
          1. intra-operative post CPB bleeding; evaluation more than 10min after heparin reversal&#xD;
             by protamin.&#xD;
&#xD;
               -  Clinically significant bleeding judged on surgeon and anesthesiologist consensual&#xD;
                  point of view&#xD;
&#xD;
               -  Sternal closure delay&#xD;
&#xD;
               -  Chest tube bleeding exceeding 50ml in 10min or more than 1ml/kg in 30min&#xD;
                  (2ml/kg/h)&#xD;
&#xD;
          2. Postoperative period , evaluation in post operative care environment after 30min&#xD;
             stabilization period&#xD;
&#xD;
               -  Chest tube bleeding exceeding 50ml in 10min or more than 1ml/kg in 30min&#xD;
                  (2ml/kg/h)&#xD;
&#xD;
               -  Patient requiring surgical re-exploration for diagnosed or suspected pericardial&#xD;
                  effusion or surgical site bleeding requiring surgical hemostatic intervention&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known congenital bleeding disorder&#xD;
&#xD;
          -  Redo surgery for patient previously included in the study&#xD;
&#xD;
          -  Implantation of Cardiac support device, Extra Corporeal Membrane Oxygenation (ECMO)&#xD;
             Extra Corporeal Life support (ECLS), uni or bi-ventricular artificial hearts.&#xD;
&#xD;
          -  Indication for post-CPB ECMO or ECLS&#xD;
&#xD;
          -  blood transfusion refusal&#xD;
&#xD;
          -  pregnant women&#xD;
&#xD;
          -  patients under 18 years old&#xD;
&#xD;
          -  Adult patient under guardianship, trusteeship or safeguard justice&#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>Bertrand Rozec, PUPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Nantes University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Angers University Hospital</name>
      <address>
        <city>Angers</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bordeaux University hospital</name>
      <address>
        <city>Bordeaux</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Caen University Hospital</name>
      <address>
        <city>Caen</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clermont-Ferrand University Hospital</name>
      <address>
        <city>Clermont-Ferrand</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dijon University Hospital</name>
      <address>
        <city>Dijon</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lille University hospital</name>
      <address>
        <city>Lille</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Marseille AP-HM La Timone</name>
      <address>
        <city>Marseille</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nancy University Hospital</name>
      <address>
        <city>Nancy</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>APHP, La Pitié Salpétrière</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HEGP, Hôpital Européen Georges Pompidou</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rouen University Hospital</name>
      <address>
        <city>Rouen</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint-Etienne University Hospital</name>
      <address>
        <city>Saint-Etienne</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Strasbourg Universtiy Hospital</name>
      <address>
        <city>Strasbourg</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Toulouse University Hospital</name>
      <address>
        <city>Toulouse</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tours University Hospital</name>
      <address>
        <city>Tours</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <reference>
    <citation>Rigal JC, Boissier E, Lakhal K, Riche VP, Durand-Zaleski I, Rozec B. Cost-effectiveness of point-of-care viscoelastic haemostatic assays in the management of bleeding during cardiac surgery: protocol for a prospective multicentre pragmatic study with stepped-wedge cluster randomised controlled design and 1-year follow-up (the IMOTEC study). BMJ Open. 2019 Nov 5;9(11):e029751. doi: 10.1136/bmjopen-2019-029751.</citation>
    <PMID>31694845</PMID>
  </reference>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>November 2, 2016</study_first_submitted>
  <study_first_submitted_qc>November 21, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 23, 2016</study_first_posted>
  <last_update_submitted>February 11, 2020</last_update_submitted>
  <last_update_submitted_qc>February 11, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 13, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Cardiopulmonary Bypass</keyword>
  <keyword>Hemorrhage</keyword>
  <keyword>blood transfusion</keyword>
  <keyword>Point-of-care test</keyword>
  <keyword>health economics</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>Hemorrhage</mesh_term>
    <mesh_term>Blood Loss, Surgical</mesh_term>
  </condition_browse>
  <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/NCT02972684
org study id: RC16_0009
nct id: NCT02972684
lead sponsor: 
collaborator: 
has dmc: No
Peri operative haemorrhage following cardio Pulmonary Bypass may occur in 5 to 10% of cardiac
      surgical interventions.

      Treatment of such complication often necessitates various combinations therapeutic
      intervention including allogenic blood products administration, drug use and/or surgical
      intervention. All are expensive treatment and decision making is guided by patient clinical
      status and biological tests of the haemostatic function.

      A key point is the time frame of the clinical process. Therapeutic choices have to be done as
      fast as possible to minimize bleeding consequences on patient haemodynamic and physiological
      status. Conventional coagulation test results availability time usually exceed 45' after
      blood drawing. In such situation, the results may not reflect precisely the coagulation
      system current state. This downside is often counterbalanced by clinicians empirical choices
      preceding lab test results knowledge that may conduct to inappropriate treatment, blood
      product overuse and undue expense.

      Viscoelastic point of care test may compensate for the limitations of conventional
      coagulation tests. In perioperative haemorrhage, faster and more precise information about
      haemostatic function may help for more accurate therapeutic choices.

      The IMOTEC study aims to compare haemorrhage management following cardiac surgery using
      conventional blood coagulation tests or thrombo-elastogaphic point of care test.

      Primary endpoint is a cost utility analysis of the technology and secondary endpoints include
      blood component transfusion, postoperative bleeding , thoracic re-intervention, postoperative
      infection (any cause), organ failure, in hospital length of stay and death.
The research is a real life, prospective, single blinded stepped wedge randomized study.

      Inclusion after informed consent of adult patient having cardio-vascular surgical procedure
      using cardiopulmonary bypass and meeting inclusion criterion "bleeding".

      After meeting inclusion criterion patients are managed either using conventional blood
      coagulation tests or using thrombo-elastometry POC test and predefined therapeutic
      interventions described in a specific algorithm.

      Other elements of patient clinical management follow usual center standard care .

      Follow up of EQ-5D and clinical evaluations are performed at one , 6 and 12 months after
      inclusion.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: Single (Outcomes Assessor)
measure: Cost-utility ratio
time frame: one year
description: incremental cost per incremental life year and incremental costs per incremental QALY
measure: incremental cost effectiveness ratio
time frame: one year
description: incremental cost effectiveness ratio : difference in costs divided by the difference in mortality and serious adverse events
measure: Complication rates
time frame: one year
description: Parameters followed during hospitalization are: volume of postoperative bleeding, allogeneic blood product transfusion, blood cell count, postoperative complications: surgical reexploration, acute kidney injury, need for renal replacement therapy, organ failure, acquired infections, mechanical ventilation duration, intensive care, and in hospital length of stay, death.
measure: Complication rates
time frame: one year
description: The major complications that can occur within 12 months are: death, cardio-thoracic surgical intervention, acute kidney injury, need for renal replacement therapy, any serious illness diagnosis.
measure: Evaluation survey
time frame: Day 1
description: Evaluation survey regarding the context and the parameters that impacted the physician's decision, which will be used a sub-group of 100 patients.
measure: The location of the Thrombo-elastometry POC testing
time frame: three years
description: The location of the Thrombo-elastometry POC testing (operative room or laboratory)
arm group label: Conventional coagulation management
arm group type: No Intervention
description: management of perioperative haemorrhage following cardiac surgery using conventional blood coagulation tests.
arm group label: Thrombo-elastometry POC testing
arm group type: Experimental
description: management of perioperative haemorrhage following cardiac surgery using the thrombo-elastometry point of care test.
intervention type: Device
intervention name: Thrombo-elastometry POC testing
description: Use of thrombo-elastometry point of care test and algorithm guided predetermined intervention during peri operative haemorrhage
arm group label: Thrombo-elastometry POC testing
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Bertrand Rozec, PUPH
role: Principal Investigator
affiliation: Nantes University Hospital
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: France
citation: Rigal JC, Boissier E, Lakhal K, Riche VP, Durand-Zaleski I, Rozec B. Cost-effectiveness of point-of-care viscoelastic haemostatic assays in the management of bleeding during cardiac surgery: protocol for a prospective multicentre pragmatic study with stepped-wedge cluster randomised controlled design and 1-year follow-up (the IMOTEC study). BMJ Open. 2019 Nov 5;9(11):e029751. doi: 10.1136/bmjopen-2019-029751.
PMID: 31694845
responsible party type: Sponsor
mesh term: Hemostatic Disorders
mesh term: Blood Coagulation Disorders
mesh term: Hemorrhage
mesh term: Blood Loss, Surgical
sharing ipd: No