<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/NCT04460222</url>
  </required_header>
  <id_info>
    <org_study_id>ILBS-Cirrhosis-26</org_study_id>
    <nct_id>NCT04460222</nct_id>
  </id_info>
  <brief_title>Rotational Thromboelastometry Guided Blood Component Use in Children With Cirrhosis Undergoing Invasive Procedures: A Randomized Controlled Trial</brief_title>
  <official_title>Rotational Thromboelastometry Guided Blood Component Use in Children With Cirrhosis Undergoing Invasive Procedures: A Randomized Controlled Trial</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>
  <oversight_info>
    <has_dmc>No</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>
      Blood products are commonly used before invasive procedures in patients with end-stage liver&#xD;
      diseases despite cirrhosis being a thrombophilic state. Traditional coagulation tests [namely&#xD;
      International Normalised Ratio (INR) and Platelets count] are known to be unreliable in&#xD;
      predicting bleeding risk before invasive procedures and in representing the real coagulation&#xD;
      status of cirrhotic patients. Notwithstanding they are still used to guide blood products&#xD;
      administration before invasive procedures. Rotational Thromboelastometry ( ROTEM) has been&#xD;
      shown to be effective in detecting signs of hypo-hypercoagulability possibly being an&#xD;
      alternative method to guide blood products transfusion. The aim of this randomized controlled&#xD;
      study is to evaluate the efficacy of ROTEM as a guide for blood products transfusion in&#xD;
      cirrhotic children undergoing invasive procedures.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Children with cirrhosis listed for invasive procedures and with deranged INR or deranged&#xD;
      platelet count will be included in the study and will be block randomized into two groups. To&#xD;
      prevent bleeding during the procedure, one group will receive prophylactic transfusion of&#xD;
      either fresh frozen plasma (FFP),Platelet or Cryoprecipitate based on the values of INR,&#xD;
      platelet and fibrinogen.The second group will undergo ROTEM based correction.&#xD;
&#xD;
      Following correction, the procedure will be done in both the groups. Patients randomized in&#xD;
      the ROTEM group will undergo repeat ROTEM and INR, Platelet, Fibrinogen testing (depending on&#xD;
      the component transfused), post the procedure, to look at the correction achieved. Similarly,&#xD;
      patients randomized in the conventional group will undergo repeat INR, Platelet, fibrinogen&#xD;
      testing depending on the component transfused.&#xD;
&#xD;
      Patients will be followed for 24 hours indoors for any evidence of bleeding or transfusion&#xD;
      reaction.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 16, 2020</start_date>
  <completion_date type="Actual">March 28, 2022</completion_date>
  <primary_completion_date type="Actual">March 28, 2022</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>Comparison in the amount of blood products transfused between the groups</measure>
    <time_frame>24 hours</time_frame>
    <description>To compare the amount of total component transfused (ml/kg) in Rotational Thromboelastometry guided therapy versus Conventional therapy for invasive procedures in children with cirrhosis</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Comparison in the amount of FFP transfused between the groups</measure>
    <time_frame>24 hours</time_frame>
    <description>To compare the amount of FFP (ml/kg) transfused in Rotational Thromboelastometry guided therapy versus Conventional therapy for invasive procedures in children with cirrhosis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparison in the amount of Platelet transfused between the groups</measure>
    <time_frame>24 hours</time_frame>
    <description>To compare the amount of Platelet transfused in Rotational Thromboelastometry guided therapy versus Conventional therapy for invasive procedures in children with cirrhosis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparison in the amount of Cryoprecipitate transfused between the groups</measure>
    <time_frame>24 hours</time_frame>
    <description>To compare the amount of Cryoprecipitate transfused in Rotational Thromboelastometry guided therapy versus Conventional therapy for invasive procedures in children with cirrhosis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-procedure bleeding</measure>
    <time_frame>24 hours</time_frame>
    <description>Comparison of the number of patients having bleeding episodes after procedure between the study groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Transfusion related side effects</measure>
    <time_frame>5 days</time_frame>
    <description>- To compare the rate of transfusion reactions in Rotational Thromboelastometry guided therapy versus Conventional therapy for invasive procedures in children with cirrhosis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparison between blood products costs between groups</measure>
    <time_frame>24 hours</time_frame>
    <description>To compare the cost of transfusion components incurred in Rotational Thromboelastometry guided therapy versus Conventional therapy for invasive procedures in children with cirrhosis</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Cirrhosis, Liver</condition>
  <arm_group>
    <arm_group_label>Rotational Thromboelastometry (ROTEM)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>To prevent bleeding during invasive procedure, cirrhotic children in the ROTEM group will receive prophylactic transfusion based on the following protocol:- EXTEM CT &gt; 80 sec - FFP will be transfused at 15 ml/kg MCF &lt; 35 mm- Platelet will be transfused at 10 ml/kg FIBTEM MCF &lt; 7 mm- Cryoprecipitate will be transfused at 5 ml/kg</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Conventional Transfusion</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>To prevent bleeding during the procedure, cirrhotic children in the conventional group will receive prophylactic transfusion if either FFP, Platelet or Cryoprecipitate is deranged based on the following protocol&#xD;
If INR: 1.5 - 2.5 FFP will be transfused at 10 ml/kg&#xD;
If Platelet Count is 20,000/mm3-50,000/mm3 Platelet will be transfused at 10 ml/kg&#xD;
If Fibrinogen &lt; 80 mg/dl Cryoprecipitate will be transfused at 5 ml/kg</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Rotational Thromboelastometry to guide blood product transfusion pre invasive procedure</intervention_name>
    <description>Rotational Thromboelastometry will be performed pre procedure and blood component will be transfused if&#xD;
EXTEM CT more than 80 sec then FFP will be transfused at 15 ml/kg MCF less than 35 mm then Platelet will be transfused at 10 ml/kg&#xD;
FIBTEM MCF less than 7 mm then Cryoprecipitate will be transfused at 5 ml/kg</description>
    <arm_group_label>Rotational Thromboelastometry (ROTEM)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Conventional transfusion methods to guide blood product transfusion pre invasive procedure</intervention_name>
    <description>Transfusion will be given If INR: 1.5 - 2.5 FFP will be transfused at 10 ml/kg If Platelet Count is 20,000/mm3-50,000/mm3 Platelet will be transfused at 10 ml/kg If Fibrinogen &lt; 80 mg/dl Cryoprecipitate will be transfused at 5 ml/kg</description>
    <arm_group_label>Conventional Transfusion</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        •Children less than 18 years of age with histologic or image proven liver cirrhosis of any&#xD;
        etiology with INR ≥ 1.5- ≤ 2.5 and/or Platelet count 20,000/mm3- 50,000/mm3 and who are&#xD;
        listed for the following invasive procedures : Low risk of bleeding&#xD;
&#xD;
          1. Central venous cannulation&#xD;
&#xD;
          2. Haemodialysis catheter&#xD;
&#xD;
          3. Ascitic or Pleural tapping&#xD;
&#xD;
          4. Endoscopic variceal ligation (EVL)&#xD;
&#xD;
          5. Endoscopic sclerotherapy (EST)&#xD;
&#xD;
        High risk of bleeding 6. TIPPS 7. Endoscopic retrograde cholangiopancreatography (ERCP)&#xD;
        with sphicterotomy 8. Percutaneous drain (PCD) Insertion 9. Biopsies other than liver&#xD;
        biopsy&#xD;
&#xD;
        For children less than 18 years with liver cirrhosis and with a platelet count between&#xD;
        40,000-60,000/mm3 and INR between 1.5-2.0 who are listed for&#xD;
&#xD;
        1) Liver biopsy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Anti platelet or anti coagulant therapy in the previous 7 days&#xD;
&#xD;
          -  Patients with clinical evidence of Disseminated intravascular coagulation (DIC) and/or&#xD;
             active bleeding&#xD;
&#xD;
          -  Hemodialysis in the past 7 days&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Institute of Liver and Biliary Sciences</name>
      <address>
        <city>New Delhi</city>
        <state>Delhi</state>
        <zip>110070</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>June 30, 2020</study_first_submitted>
  <study_first_submitted_qc>July 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>June 11, 2022</last_update_submitted>
  <last_update_submitted_qc>June 11, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 15, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>ROTEM</keyword>
  <keyword>Transfusion</keyword>
  <keyword>Pre invasive procedure</keyword>
  <keyword>Coagulation disorders</keyword>
  <keyword>Pediatric liver disease</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Liver Cirrhosis</mesh_term>
    <mesh_term>Fibrosis</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/NCT04460222
org study id: ILBS-Cirrhosis-26
nct id: NCT04460222
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Blood products are commonly used before invasive procedures in patients with end-stage liver
      diseases despite cirrhosis being a thrombophilic state. Traditional coagulation tests [namely
      International Normalised Ratio (INR) and Platelets count] are known to be unreliable in
      predicting bleeding risk before invasive procedures and in representing the real coagulation
      status of cirrhotic patients. Notwithstanding they are still used to guide blood products
      administration before invasive procedures. Rotational Thromboelastometry ( ROTEM) has been
      shown to be effective in detecting signs of hypo-hypercoagulability possibly being an
      alternative method to guide blood products transfusion. The aim of this randomized controlled
      study is to evaluate the efficacy of ROTEM as a guide for blood products transfusion in
      cirrhotic children undergoing invasive procedures.
Children with cirrhosis listed for invasive procedures and with deranged INR or deranged
      platelet count will be included in the study and will be block randomized into two groups. To
      prevent bleeding during the procedure, one group will receive prophylactic transfusion of
      either fresh frozen plasma (FFP),Platelet or Cryoprecipitate based on the values of INR,
      platelet and fibrinogen.The second group will undergo ROTEM based correction.

      Following correction, the procedure will be done in both the groups. Patients randomized in
      the ROTEM group will undergo repeat ROTEM and INR, Platelet, Fibrinogen testing (depending on
      the component transfused), post the procedure, to look at the correction achieved. Similarly,
      patients randomized in the conventional group will undergo repeat INR, Platelet, fibrinogen
      testing depending on the component transfused.

      Patients will be followed for 24 hours indoors for any evidence of bleeding or transfusion
      reaction.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Comparison in the amount of blood products transfused between the groups
time frame: 24 hours
description: To compare the amount of total component transfused (ml/kg) in Rotational Thromboelastometry guided therapy versus Conventional therapy for invasive procedures in children with cirrhosis
measure: Comparison in the amount of FFP transfused between the groups
time frame: 24 hours
description: To compare the amount of FFP (ml/kg) transfused in Rotational Thromboelastometry guided therapy versus Conventional therapy for invasive procedures in children with cirrhosis
measure: Comparison in the amount of Platelet transfused between the groups
time frame: 24 hours
description: To compare the amount of Platelet transfused in Rotational Thromboelastometry guided therapy versus Conventional therapy for invasive procedures in children with cirrhosis
measure: Comparison in the amount of Cryoprecipitate transfused between the groups
time frame: 24 hours
description: To compare the amount of Cryoprecipitate transfused in Rotational Thromboelastometry guided therapy versus Conventional therapy for invasive procedures in children with cirrhosis
measure: Post-procedure bleeding
time frame: 24 hours
description: Comparison of the number of patients having bleeding episodes after procedure between the study groups
measure: Transfusion related side effects
time frame: 5 days
description: - To compare the rate of transfusion reactions in Rotational Thromboelastometry guided therapy versus Conventional therapy for invasive procedures in children with cirrhosis
measure: Comparison between blood products costs between groups
time frame: 24 hours
description: To compare the cost of transfusion components incurred in Rotational Thromboelastometry guided therapy versus Conventional therapy for invasive procedures in children with cirrhosis
arm group label: Rotational Thromboelastometry (ROTEM)
arm group type: Experimental
description: To prevent bleeding during invasive procedure, cirrhotic children in the ROTEM group will receive prophylactic transfusion based on the following protocol:- EXTEM CT > 80 sec - FFP will be transfused at 15 ml/kg MCF < 35 mm- Platelet will be transfused at 10 ml/kg FIBTEM MCF < 7 mm- Cryoprecipitate will be transfused at 5 ml/kg
arm group label: Conventional Transfusion
arm group type: Active Comparator
description: To prevent bleeding during the procedure, cirrhotic children in the conventional group will receive prophylactic transfusion if either FFP, Platelet or Cryoprecipitate is deranged based on the following protocol
If INR: 1.5 - 2.5 FFP will be transfused at 10 ml/kg
If Platelet Count is 20,000/mm3-50,000/mm3 Platelet will be transfused at 10 ml/kg
If Fibrinogen < 80 mg/dl Cryoprecipitate will be transfused at 5 ml/kg
intervention type: Procedure
intervention name: Rotational Thromboelastometry to guide blood product transfusion pre invasive procedure
description: Rotational Thromboelastometry will be performed pre procedure and blood component will be transfused if
EXTEM CT more than 80 sec then FFP will be transfused at 15 ml/kg MCF less than 35 mm then Platelet will be transfused at 10 ml/kg
FIBTEM MCF less than 7 mm then Cryoprecipitate will be transfused at 5 ml/kg
arm group label: Rotational Thromboelastometry (ROTEM)
intervention type: Procedure
intervention name: Conventional transfusion methods to guide blood product transfusion pre invasive procedure
description: Transfusion will be given If INR: 1.5 - 2.5 FFP will be transfused at 10 ml/kg If Platelet Count is 20,000/mm3-50,000/mm3 Platelet will be transfused at 10 ml/kg If Fibrinogen < 80 mg/dl Cryoprecipitate will be transfused at 5 ml/kg
arm group label: Conventional Transfusion
criteria: 
gender: All
minimum age: N/A
maximum age: 18 Years
healthy volunteers: No
facility: 
country: India
responsible party type: Sponsor
mesh term: Liver Cirrhosis
mesh term: Fibrosis
sharing ipd: No