<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/NCT03275077</url>
  </required_header>
  <id_info>
    <org_study_id>ILBS-TEG-001</org_study_id>
    <nct_id>NCT03275077</nct_id>
  </id_info>
  <brief_title>To Compare TEG (Thrombelastography) and Conventional Tests in CKD Patients</brief_title>
  <official_title>A Comparative Evaluation of Thromboelastogram and Conventional Coagulation Tests To Detect Coagulopathy in End Stage Renal Disease Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Institute of Liver and Biliary Sciences, India</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Institute of Liver and Biliary Sciences, India</source>
  <brief_summary>
    <textblock>
      Background: Coagulopathy in chronic kidney disease is multifactorial. Both hypocoagulopathy&#xD;
      and hypercoaguability are seen. Conventional tests of coagulation (CCTs) end at the formation&#xD;
      of thrombin, and do not take into account the interaction of coagulation factors, platelets,&#xD;
      RBC etc. By overcoming the above deficiencies, thromboelastography provides a holistic&#xD;
      picture of blood coagulation. The present study evaluated the TEG profile of ESRD patients&#xD;
      and compared it to CCTs and to controls.&#xD;
&#xD;
      Methods: 50 ESRD patients and 50 controls were recruited for the study. Venous samples were&#xD;
      withdrawn and platelet count, INR and fibrinogen levels were measured. Simultaneously a&#xD;
      Thromboelastography was performed. All samples were drawn prior to initiation of dialysis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 12, 2016</start_date>
  <completion_date type="Actual">December 22, 2016</completion_date>
  <primary_completion_date type="Actual">December 22, 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>To compare the maximum amplitude on a thromboelastography in patients of chronic kidney disease stage 5 with normal controls.</measure>
    <time_frame>0 hr</time_frame>
    <description>Maximum amplitude in whole blood will be measures by a standard kaolin thromboelastography in all patients and controls.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>To correlate the maximum amplitude with platelet count and fibrinogen levels in patients of chronic kidney disease</measure>
    <time_frame>0 hr</time_frame>
    <description>the maximum amplitude obtained on an thromboelastography denotes clot strength which depends on platelet count and fibrinogen levels. thus an attempt will be made to corelate these values with fibrinogen levels and platelet count.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">100</enrollment>
  <condition>End Stage Renal Disease</condition>
  <condition>Coagulopathy</condition>
  <arm_group>
    <arm_group_label>Controls</arm_group_label>
    <description>Normal Healthy Volunteers</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ESRD patients</arm_group_label>
    <description>Patients with ESRD who have not received hemodialysis. Patients with known bleeding disorders, coexisting liver diseases, those who were on antiplatelet or anticoagulant therapy and patients who had received red blood cells, fresh frozen plasma or platelet transfusions in the past three months were excluded from the study.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Thromboelastography</intervention_name>
    <description>A viscoelastic test of coagulation</description>
    <arm_group_label>Controls</arm_group_label>
    <arm_group_label>ESRD patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        A total of 100 patients were recruited for the study based on the above criteria.Following&#xD;
        enrollment, patients were divided into two groups as follows Group 1(Control Group): 50&#xD;
        patients who were healthy voluntary donors belonging to ASA PSI or ASA PSII Group 2(ESRD&#xD;
        Group): 50 patients suffering from end stage renal disease i.e. CKD stage 5 (Defined by&#xD;
        KDIGO 2012) who never received renal replacement therapy (RRT&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Healthy voluntary donors belonging to ASA PSI or ASA PSII&#xD;
&#xD;
          2. Patients suffering from end stage renal disease i.e. CKD stage 5 (Defined by KDIGO&#xD;
             2012 ) who never received renal replacement therapy (RRT)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients on antiplatelet drugs, erythropoietin, desmopressin&#xD;
&#xD;
          2. Patients with known bleeding disorders like haemophilia, aplastic anaemia etc&#xD;
&#xD;
          3. Patients having coexisting liver diseases&#xD;
&#xD;
          4. Patients on dialysis&#xD;
&#xD;
          5. Patients who have received PRBC, FFPs or Platelet Transfusions in the past 3 months&#xD;
&#xD;
          6. Patients less than 18 years of age&#xD;
&#xD;
          7. Pregnant patients&#xD;
&#xD;
          8. Malignancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>June 2018</verification_date>
  <study_first_submitted>August 16, 2017</study_first_submitted>
  <study_first_submitted_qc>September 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 7, 2017</study_first_posted>
  <last_update_submitted>June 11, 2018</last_update_submitted>
  <last_update_submitted_qc>June 11, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">June 12, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Institute of Liver and Biliary Sciences, India</investigator_affiliation>
    <investigator_full_name>kelika Prakash</investigator_full_name>
    <investigator_title>Asssitant Professor, Department of Anaesthesiology</investigator_title>
  </responsible_party>
  <keyword>End stage renal disease</keyword>
  <keyword>ESRD</keyword>
  <keyword>Thromboelastography</keyword>
  <keyword>Fibrinogen</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Kidney Diseases</mesh_term>
    <mesh_term>Kidney Failure, Chronic</mesh_term>
    <mesh_term>Hemostatic Disorders</mesh_term>
    <mesh_term>Blood Coagulation Disorders</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/NCT03275077
org study id: ILBS-TEG-001
nct id: NCT03275077
lead sponsor: 
Background: Coagulopathy in chronic kidney disease is multifactorial. Both hypocoagulopathy
      and hypercoaguability are seen. Conventional tests of coagulation (CCTs) end at the formation
      of thrombin, and do not take into account the interaction of coagulation factors, platelets,
      RBC etc. By overcoming the above deficiencies, thromboelastography provides a holistic
      picture of blood coagulation. The present study evaluated the TEG profile of ESRD patients
      and compared it to CCTs and to controls.

      Methods: 50 ESRD patients and 50 controls were recruited for the study. Venous samples were
      withdrawn and platelet count, INR and fibrinogen levels were measured. Simultaneously a
      Thromboelastography was performed. All samples were drawn prior to initiation of dialysis.
observational model: Case-Control
time perspective: Prospective
measure: To compare the maximum amplitude on a thromboelastography in patients of chronic kidney disease stage 5 with normal controls.
time frame: 0 hr
description: Maximum amplitude in whole blood will be measures by a standard kaolin thromboelastography in all patients and controls.
measure: To correlate the maximum amplitude with platelet count and fibrinogen levels in patients of chronic kidney disease
time frame: 0 hr
description: the maximum amplitude obtained on an thromboelastography denotes clot strength which depends on platelet count and fibrinogen levels. thus an attempt will be made to corelate these values with fibrinogen levels and platelet count.
arm group label: Controls
description: Normal Healthy Volunteers
arm group label: ESRD patients
description: Patients with ESRD who have not received hemodialysis. Patients with known bleeding disorders, coexisting liver diseases, those who were on antiplatelet or anticoagulant therapy and patients who had received red blood cells, fresh frozen plasma or platelet transfusions in the past three months were excluded from the study.
intervention type: Device
intervention name: Thromboelastography
description: A viscoelastic test of coagulation
arm group label: Controls
arm group label: ESRD patients
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: Institute of Liver and Biliary Sciences, India
investigator full name: kelika Prakash
investigator title: Asssitant Professor, Department of Anaesthesiology
mesh term: Kidney Diseases
mesh term: Kidney Failure, Chronic
mesh term: Hemostatic Disorders
mesh term: Blood Coagulation Disorders