xml: <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/NCT06037720</url>
    </required_header>
    <id_info>
      <org_study_id>PeriopCoaguChek</org_study_id>
      <nct_id>NCT06037720</nct_id>
    </id_info>
    <brief_title>Diagnostic Accuracy Study of a Point-of-Care Test for Coagulation Function</brief_title>
    <official_title>Diagnostic Accuracy Study of a Point-of-Care Test for Coagulation Function: CoaguChek System Versus Standard Laboratory Tests in Cardiac Surgery Requiring Cardiopulmonary Bypass</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Hospital de Base</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Hospital de Base</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Intraoperative coagulopathies in complex procedures are common. For the diagnosis and&#xD;
        adequate therapy, laboratory tests are necessary, which can delay the patient's therapy. In&#xD;
        this sense, the study aims to evaluate the point-of-care test device for patients undergoing&#xD;
        surgeries with cardiopulmonary bypass.&#xD;
  &#xD;
        Objective: To analyze the accuracy between the point-of-care diagnostic method and the&#xD;
        laboratory test considered the gold standard for checking the INR.&#xD;
  &#xD;
        Methodology: Cross-sectional study of diagnostic accuracy with simultaneous testing of the&#xD;
        Coaguchek XS device and standard laboratory method in patients undergoing cardiopulmonary&#xD;
        bypass to evaluate INR results.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Laboratory evaluation of blood clotting is widely used in perioperative medicine, either by&#xD;
        conventional technique (prothrombin time - PT/INR, Activated Partial Thromboplastin Time -&#xD;
        aPTT, fibrinogen dosage and platelet count) or by the Point of Care method (Thromboelastogram&#xD;
        ) - notably in surgical procedures with the possibility of severe volume loss&#xD;
        (cardiovascular, oncological, trauma, etc.).&#xD;
  &#xD;
        The prothrombin time (PT) is a general assessment of the integrity of the extrinsic and&#xD;
        common pathway of coagulation. It determines the time of formation of the fibrin clot. The&#xD;
        INR/RNI (International Normalized Ratio) is calculated from the PT and is intended to&#xD;
        establish valid comparisons regardless of the type of PT reagent (known as thromboplastin)&#xD;
        used by different clinical laboratories. The INR is indicated for evaluating the integrity of&#xD;
        the extrinsic (factor VII*) and common pathway (fibrinogen and factors II*, V and X*), and&#xD;
        for monitoring the anticoagulant effect of an anti-vitamin K agent (warfarin), capable of&#xD;
        inhibiting the synthesis of vitamin K dependent factors (II, VII, IX, X, proteins C and S).&#xD;
  &#xD;
        Today, due to its safety, sensitivity and speed, the thromboelastogram is recommended as the&#xD;
        method of choice for assessing hemostasis in a surgical setting. However, because it is still&#xD;
        not widespread in many centers, mainly due to its high cost, many hospitals are limited to&#xD;
        the use of traditional laboratory methods which, despite their undeniable reliability,&#xD;
        require more time for their execution and release of results.&#xD;
  &#xD;
        In cardiac surgery with cardiopulmonary bypass (CPB), the use of prime solution to fill the&#xD;
        CPB circuit results in hemodilution of coagulation factors, with factor I (fibrinogen) being&#xD;
        one of the most affected, but not the only one. Each abnormality detected requires a specific&#xD;
        action. Thus, the activated clotting time (ACT) is normalized with the administration of&#xD;
        protamine. Thrombocytopenia and/or platelet dysfunction, with platelet concentrate infusion.&#xD;
        Abnormalities in clotting factors, with administration of the specific factor, eg fibrinogen,&#xD;
        either by factor concentrate, cryoprecipitate or plasma. It is at this moment that a quick&#xD;
        assessment of hemostasis, in a global and individualized way at the same time, is necessary.&#xD;
  &#xD;
        More than a decade ago, devices appeared on the market designed to help patients using&#xD;
        warfarin to maintain their anticoagulation within parameters established for each case,&#xD;
        providing safety, speed and comfort. Using a reagent strip and a drop of blood, evaluating&#xD;
        the INR has become as simple as evaluating capillary blood glucose for diabetic patients. In&#xD;
        just a few seconds, INR assessment can show significant changes in the extrinsic coagulation&#xD;
        pathway, an important step to help with rapid decision-making in surgical environments. The&#xD;
        Coaguchek Device, validated and used for outpatient management of patients using Warfarin,&#xD;
        presents valuable characteristics for this purpose (simplicity, speed, safety), also&#xD;
        important in the context of intraoperative decision-making. There are few reports in the&#xD;
        literature on the use of the Coaguchek device in surgery and on the reliability of the data&#xD;
        obtained through its use.&#xD;
  &#xD;
        To evaluate this correlation, the main objective of the present study is to evaluate the&#xD;
        effectiveness of the portable INR meter in a surgical setting and comparing it with&#xD;
        conventional laboratory methods. The proposal is a cross-sectional diagnostic study in&#xD;
        patients scheduled electively to undergo cardiac surgery with cardiopulmonary bypass at&#xD;
        Hospital de Base in the Federal District.&#xD;
  &#xD;
        All patients will receive standard monitoring associated with hemodynamic monitoring with&#xD;
        invasive blood pressure and central venous access. Balanced general inhalation anesthesia&#xD;
        will be administered to all patients. Hemodynamic support with dobutamine, noradrenaline,&#xD;
        nitroprusside, nitroglycerin, vasopressin, or milrinone will be offered according to&#xD;
        perioperative needs. The same commercial brand of heparin and protamine will be used to all&#xD;
        the patients.&#xD;
  &#xD;
        Laboratory tests, including samples for the Coaguchek device strip, will be collected 10&#xD;
        minutes before heparin administration and 10 minutes after the end of the protamine infusion.&#xD;
        The laboratory exams that will be collected are: arterial blood gases, venous blood gases,&#xD;
        electrolytes, complete blood count, coagulogram (TAP, aPTT, INR) and fibrinogen.&#xD;
  &#xD;
        The sample size was calculated for the limits of agreement by Bland and Altman (1986)1,&#xD;
        according to the method developed by Lu et al. (2016).2 Based on previous studies3-5, we&#xD;
        assumed a mean difference between the POC test and the laboratory test of 0.126 units with a&#xD;
        standard deviation of 0.132. Furthermore, based on clinical criteria, we consider that an&#xD;
        absolute difference greater than 0.5 units will be clinically relevant. In other words, the&#xD;
        maximum difference (Δ) between the tests (so as not to change the clinical approach) would be&#xD;
        up to ± 0.5 units; that is, (-Δ ,Δ) equals (-0.5,0.5). Assuming a 5% ɑ level and 95%&#xD;
        confidence intervals around the Bland-Altman limits of agreement, 43 participants were needed&#xD;
        to ensure a statistical power of 90% to detect agreement between the two methods. All&#xD;
        calculations were performed using the Stata 16 program (StataCorp, Texas, United States). We&#xD;
        decided to increase the sample to 50 patients for cases of loss to follow-up or failures in&#xD;
        annotations.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">January 2024</completion_date>
    <primary_completion_date type="Anticipated">January 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Crossover</observational_model>
      <time_perspective>Cross-Sectional</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Point-of-care diagnostic method</measure>
      <time_frame>During surgery</time_frame>
      <description>To analyze the accuracy between the point-of-care diagnostic method and the laboratory test considered the gold standard for verifying the INR.</description>
    </primary_outcome>
    <enrollment type="Anticipated">50</enrollment>
    <condition>CoaguChek® XS System</condition>
    <condition>Coagulation Function</condition>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Coaguchek testing</intervention_name>
      <description>Patients scheduled electively to undergo cardiac surgery with cardiopulmonary bypass at Hospital de Base in the Federal District.</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patients scheduled electively to undergo cardiac surgery with cardiopulmonary bypass at&#xD;
          Hospital de Base in the Federal District.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  patients over 18 years old&#xD;
  &#xD;
            -  admitted to the Hospital de Base of the Federal District for cardiac surgery, who&#xD;
               volunteered to participate in the examination both by the traditional method of venous&#xD;
               INR examination and by the use of the Coaguchek device and only after signing the&#xD;
               TCLE.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  patients who give up the research even after signing the TCLE will be excluded&#xD;
  &#xD;
            -  patients who do not meet the aforementioned inclusion criteria&#xD;
  &#xD;
            -  patients who refuse to participate in the study&#xD;
  &#xD;
            -  patients with kidney, liver, hematological disease or any disease that affects&#xD;
               coagulation&#xD;
  &#xD;
            -  patients participating in other studies&#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_contact>
      <last_name>Nadja Gloria C Graça, MD</last_name>
      <phone>556133151588</phone>
      <email>nadjagcg@hotmail.com</email>
    </overall_contact>
    <reference>
      <citation>Khalaf-Adeli E, Alavi M, Alizadeh-Ghavidel A, Pourfathollah AA. Comparison of standard coagulation testing with thromboelastometry tests in cardiac surgery. J Cardiovasc Thorac Res. 2019;11(4):300-304. doi: 10.15171/jcvtr.2019.48. Epub 2019 Oct 13.</citation>
      <PMID>31824611</PMID>
    </reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 7, 2023</study_first_submitted>
    <study_first_submitted_qc>September 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 14, 2023</study_first_posted>
    <last_update_submitted>September 7, 2023</last_update_submitted>
    <last_update_submitted_qc>September 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Hospital de Base</investigator_affiliation>
      <investigator_full_name>Fabricio Tavares Mendonca</investigator_full_name>
      <investigator_title>MD, MSc, PhD</investigator_title>
    </responsible_party>
    <keyword>CoaguChek® XS System</keyword>
    <keyword>International normalized ratio</keyword>
    <keyword>Point-of-care testing</keyword>
    <keyword>Cardiopulmonary bypass</keyword>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06037720
  org study id: PeriopCoaguChek
  nct id: NCT06037720
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Intraoperative coagulopathies in complex procedures are common. For the diagnosis and
        adequate therapy, laboratory tests are necessary, which can delay the patient's therapy. In
        this sense, the study aims to evaluate the point-of-care test device for patients undergoing
        surgeries with cardiopulmonary bypass.
  
        Objective: To analyze the accuracy between the point-of-care diagnostic method and the
        laboratory test considered the gold standard for checking the INR.
  
        Methodology: Cross-sectional study of diagnostic accuracy with simultaneous testing of the
        Coaguchek XS device and standard laboratory method in patients undergoing cardiopulmonary
        bypass to evaluate INR results.
  Laboratory evaluation of blood clotting is widely used in perioperative medicine, either by
        conventional technique (prothrombin time - PT/INR, Activated Partial Thromboplastin Time -
        aPTT, fibrinogen dosage and platelet count) or by the Point of Care method (Thromboelastogram
        ) - notably in surgical procedures with the possibility of severe volume loss
        (cardiovascular, oncological, trauma, etc.).
  
        The prothrombin time (PT) is a general assessment of the integrity of the extrinsic and
        common pathway of coagulation. It determines the time of formation of the fibrin clot. The
        INR/RNI (International Normalized Ratio) is calculated from the PT and is intended to
        establish valid comparisons regardless of the type of PT reagent (known as thromboplastin)
        used by different clinical laboratories. The INR is indicated for evaluating the integrity of
        the extrinsic (factor VII*) and common pathway (fibrinogen and factors II*, V and X*), and
        for monitoring the anticoagulant effect of an anti-vitamin K agent (warfarin), capable of
        inhibiting the synthesis of vitamin K dependent factors (II, VII, IX, X, proteins C and S).
  
        Today, due to its safety, sensitivity and speed, the thromboelastogram is recommended as the
        method of choice for assessing hemostasis in a surgical setting. However, because it is still
        not widespread in many centers, mainly due to its high cost, many hospitals are limited to
        the use of traditional laboratory methods which, despite their undeniable reliability,
        require more time for their execution and release of results.
  
        In cardiac surgery with cardiopulmonary bypass (CPB), the use of prime solution to fill the
        CPB circuit results in hemodilution of coagulation factors, with factor I (fibrinogen) being
        one of the most affected, but not the only one. Each abnormality detected requires a specific
        action. Thus, the activated clotting time (ACT) is normalized with the administration of
        protamine. Thrombocytopenia and/or platelet dysfunction, with platelet concentrate infusion.
        Abnormalities in clotting factors, with administration of the specific factor, eg fibrinogen,
        either by factor concentrate, cryoprecipitate or plasma. It is at this moment that a quick
        assessment of hemostasis, in a global and individualized way at the same time, is necessary.
  
        More than a decade ago, devices appeared on the market designed to help patients using
        warfarin to maintain their anticoagulation within parameters established for each case,
        providing safety, speed and comfort. Using a reagent strip and a drop of blood, evaluating
        the INR has become as simple as evaluating capillary blood glucose for diabetic patients. In
        just a few seconds, INR assessment can show significant changes in the extrinsic coagulation
        pathway, an important step to help with rapid decision-making in surgical environments. The
        Coaguchek Device, validated and used for outpatient management of patients using Warfarin,
        presents valuable characteristics for this purpose (simplicity, speed, safety), also
        important in the context of intraoperative decision-making. There are few reports in the
        literature on the use of the Coaguchek device in surgery and on the reliability of the data
        obtained through its use.
  
        To evaluate this correlation, the main objective of the present study is to evaluate the
        effectiveness of the portable INR meter in a surgical setting and comparing it with
        conventional laboratory methods. The proposal is a cross-sectional diagnostic study in
        patients scheduled electively to undergo cardiac surgery with cardiopulmonary bypass at
        Hospital de Base in the Federal District.
  
        All patients will receive standard monitoring associated with hemodynamic monitoring with
        invasive blood pressure and central venous access. Balanced general inhalation anesthesia
        will be administered to all patients. Hemodynamic support with dobutamine, noradrenaline,
        nitroprusside, nitroglycerin, vasopressin, or milrinone will be offered according to
        perioperative needs. The same commercial brand of heparin and protamine will be used to all
        the patients.
  
        Laboratory tests, including samples for the Coaguchek device strip, will be collected 10
        minutes before heparin administration and 10 minutes after the end of the protamine infusion.
        The laboratory exams that will be collected are: arterial blood gases, venous blood gases,
        electrolytes, complete blood count, coagulogram (TAP, aPTT, INR) and fibrinogen.
  
        The sample size was calculated for the limits of agreement by Bland and Altman (1986)1,
        according to the method developed by Lu et al. (2016).2 Based on previous studies3-5, we
        assumed a mean difference between the POC test and the laboratory test of 0.126 units with a
        standard deviation of 0.132. Furthermore, based on clinical criteria, we consider that an
        absolute difference greater than 0.5 units will be clinically relevant. In other words, the
        maximum difference (Δ) between the tests (so as not to change the clinical approach) would be
        up to ± 0.5 units; that is, (-Δ ,Δ) equals (-0.5,0.5). Assuming a 5% ɑ level and 95%
        confidence intervals around the Bland-Altman limits of agreement, 43 participants were needed
        to ensure a statistical power of 90% to detect agreement between the two methods. All
        calculations were performed using the Stata 16 program (StataCorp, Texas, United States). We
        decided to increase the sample to 50 patients for cases of loss to follow-up or failures in
        annotations.
  observational model: Case-Crossover
  time perspective: Cross-Sectional
  measure: Point-of-care diagnostic method
  time frame: During surgery
  description: To analyze the accuracy between the point-of-care diagnostic method and the laboratory test considered the gold standard for verifying the INR.
  intervention type: Device
  intervention name: Coaguchek testing
  description: Patients scheduled electively to undergo cardiac surgery with cardiopulmonary bypass at Hospital de Base in the Federal District.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Nadja Gloria C Graça, MD
  phone: 556133151588
  email: nadjagcg@hotmail.com
  citation: Khalaf-Adeli E, Alavi M, Alizadeh-Ghavidel A, Pourfathollah AA. Comparison of standard coagulation testing with thromboelastometry tests in cardiac surgery. J Cardiovasc Thorac Res. 2019;11(4):300-304. doi: 10.15171/jcvtr.2019.48. Epub 2019 Oct 13.
  PMID: 31824611
  responsible party type: Principal Investigator
  investigator affiliation: Hospital de Base
  investigator full name: Fabricio Tavares Mendonca
  investigator title: MD, MSc, PhD