<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/NCT04442373</url>
  </required_header>
  <id_info>
    <org_study_id>ROTEM-THR</org_study_id>
    <nct_id>NCT04442373</nct_id>
  </id_info>
  <brief_title>Impact of Surgical Injury on Haemostatic Tests in Patients Undergoing Total Hip Replacement With Subgroup Analysis of Patients With Neoplasm</brief_title>
  <acronym>I-SIGHT-THR</acronym>
  <official_title>Impact of Surgical Injury on Global Haemostatic Tests in Patients Undergoing Total Hip Replacement With Subgroup Analysis of Patients With Bone Neoplasm. A Single-centre Observational Prospective Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University of Warsaw</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medical University of Warsaw</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>
      Total hip replacement (THR) is associated with extensive tissue injury and considerable blood&#xD;
      loss that can be complicated by hyperfibrinolysis with an increased need for blood&#xD;
      transfusion. THR in patients with cancer involving the hip joint, can reduce pain and improve&#xD;
      or maintain the function and quality of life. However, these patients have an increased&#xD;
      likelihood of haemostatic abnormalities, such as thrombosis or extensive blood loss.&#xD;
      Rotational thromboelastometry is a point-of-care viscoelastic assay that can provide a&#xD;
      measure of coagulation disorders in the above settings, and this is still under review. The&#xD;
      objective of this prospective cohort study is to quantitate the changes in clot formation&#xD;
      dynamics following THR with a subgroup analysis of patients with cancer.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 1, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>INTEM parameters change from preoperative to postoperative values</measure>
    <time_frame>30 minutes before and 30 minutes after surgery</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>EXTEM parameters change from preoperative to postoperative values</measure>
    <time_frame>30 minutes before and 30 minutes after surgery</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>FIBTEM parameter change from preoperative to postoperative values</measure>
    <time_frame>30 minutes before and 30 minutes after surgery</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Total volume of infused fluids</measure>
    <time_frame>From first fluid on day of surgery to end of surgery, an average of 12 hours</time_frame>
    <description>Crystalloids, blood products</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pre- and postoperative haemoglobin and haematocrit</measure>
    <time_frame>From day before surgery to postoperative day 3</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intraoperative blood loss</measure>
    <time_frame>Blood loss as measured during surgery</time_frame>
    <description>Amount of blood loss in millilitres</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hip Disability and Osteoarthritis Outcome Score (HOOS)</measure>
    <time_frame>The day before surgery and at 6 ± 1 months, 12 ± 1 month after surgery</time_frame>
    <description>Instrument for measuring outcome following surgery with higher scores representing better function. Score from 0 to 100.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The 36-Item Short Form Health Survey (SF-36)</measure>
    <time_frame>The day before surgery and at 6 ± 1 months, 12 ± 1 month after surgery</time_frame>
    <description>Health related Quality of Life measure. Higher score indicates better health state with eight scaled scores each from 0 to 100.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Visual Analogue Scale (VAS) score</measure>
    <time_frame>The day before surgery and at 6 ± 1 months, 12 ± 1 month after surgery</time_frame>
    <description>The ends of the scale are defined as the extreme limits of the pain. Orientated from the left (no pain) to the right (worst imaginable pain) measured in millimeters from 0 to 100.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Rate of thrombotic events</measure>
    <time_frame>up to 12 months after surgery</time_frame>
    <description>Pulmonary embolism, deep and superficial vein thrombosis</description>
  </other_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Total Hip Replacement</condition>
  <condition>Thromboelastometry</condition>
  <condition>Bone Neoplasm of Hip</condition>
  <arm_group>
    <arm_group_label>Patients undergoing THR with no known bone neoplasm</arm_group_label>
    <description>Pre- and postoperative blood sampling for ROTEM assessment in THR patients</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Patients undergoing THR with known bone neoplasm</arm_group_label>
    <description>Pre- and postoperative blood sampling for ROTEM assessment before and after THR in patients with bone neoplasm</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Rotational thromboelastometry</intervention_name>
    <description>1.8 ml blood sample</description>
    <arm_group_label>Patients undergoing THR with known bone neoplasm</arm_group_label>
    <arm_group_label>Patients undergoing THR with no known bone neoplasm</arm_group_label>
    <other_name>ROTEM</other_name>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Arterial blood samples&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients undergoing elective total hip replacement&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients undergoing primary elective total hip replacement&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients unable to consent to trial&#xD;
&#xD;
          -  Active deep and superficial vein thrombosis&#xD;
&#xD;
          -  Coagulopathy in initial coagulation screen tests&#xD;
&#xD;
          -  Platelet count below 100 thousand&#xD;
&#xD;
          -  Patients on antithrombotic medications (except prophylactic low molecular weight&#xD;
             heparins and acetylsalicylic acid up to 75 mg per day)&#xD;
&#xD;
          -  Preoperative haemoglobin &lt; 10 g/dl&#xD;
&#xD;
          -  Female patients who are pregnant or nursing&#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>Jan Pluta, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medical University of Warsaw</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Marek Janiak, MD</last_name>
    <phone>0048225021724</phone>
    <email>mjaniak1@wum.edu.pl</email>
  </overall_contact>
  <location>
    <facility>
      <name>I Department of Anesthesiology and Intensive Care Warsaw Medical University</name>
      <address>
        <city>Warsaw</city>
        <state>Mazowieckie</state>
        <zip>02-005</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Marek Janiak, MD</last_name>
      <phone>0048225021724</phone>
      <email>klinanest1@wum.edu.pl</email>
    </contact>
  </location>
  <location_countries>
    <country>Poland</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>March 8, 2020</study_first_submitted>
  <study_first_submitted_qc>June 19, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 22, 2020</study_first_posted>
  <last_update_submitted>April 26, 2022</last_update_submitted>
  <last_update_submitted_qc>April 26, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 27, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Medical University of Warsaw</investigator_affiliation>
    <investigator_full_name>Jan Pluta</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasms</mesh_term>
    <mesh_term>Bone Neoplasms</mesh_term>
    <mesh_term>Intraoperative Complications</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04442373
org study id: ROTEM-THR
nct id: NCT04442373
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Total hip replacement (THR) is associated with extensive tissue injury and considerable blood
      loss that can be complicated by hyperfibrinolysis with an increased need for blood
      transfusion. THR in patients with cancer involving the hip joint, can reduce pain and improve
      or maintain the function and quality of life. However, these patients have an increased
      likelihood of haemostatic abnormalities, such as thrombosis or extensive blood loss.
      Rotational thromboelastometry is a point-of-care viscoelastic assay that can provide a
      measure of coagulation disorders in the above settings, and this is still under review. The
      objective of this prospective cohort study is to quantitate the changes in clot formation
      dynamics following THR with a subgroup analysis of patients with cancer.
observational model: Cohort
time perspective: Prospective
measure: INTEM parameters change from preoperative to postoperative values
time frame: 30 minutes before and 30 minutes after surgery
measure: EXTEM parameters change from preoperative to postoperative values
time frame: 30 minutes before and 30 minutes after surgery
measure: FIBTEM parameter change from preoperative to postoperative values
time frame: 30 minutes before and 30 minutes after surgery
measure: Total volume of infused fluids
time frame: From first fluid on day of surgery to end of surgery, an average of 12 hours
description: Crystalloids, blood products
measure: Pre- and postoperative haemoglobin and haematocrit
time frame: From day before surgery to postoperative day 3
measure: Intraoperative blood loss
time frame: Blood loss as measured during surgery
description: Amount of blood loss in millilitres
measure: Hip Disability and Osteoarthritis Outcome Score (HOOS)
time frame: The day before surgery and at 6 ± 1 months, 12 ± 1 month after surgery
description: Instrument for measuring outcome following surgery with higher scores representing better function. Score from 0 to 100.
measure: The 36-Item Short Form Health Survey (SF-36)
time frame: The day before surgery and at 6 ± 1 months, 12 ± 1 month after surgery
description: Health related Quality of Life measure. Higher score indicates better health state with eight scaled scores each from 0 to 100.
measure: Visual Analogue Scale (VAS) score
time frame: The day before surgery and at 6 ± 1 months, 12 ± 1 month after surgery
description: The ends of the scale are defined as the extreme limits of the pain. Orientated from the left (no pain) to the right (worst imaginable pain) measured in millimeters from 0 to 100.
measure: Rate of thrombotic events
time frame: up to 12 months after surgery
description: Pulmonary embolism, deep and superficial vein thrombosis
arm group label: Patients undergoing THR with no known bone neoplasm
description: Pre- and postoperative blood sampling for ROTEM assessment in THR patients
arm group label: Patients undergoing THR with known bone neoplasm
description: Pre- and postoperative blood sampling for ROTEM assessment before and after THR in patients with bone neoplasm
intervention type: Diagnostic Test
intervention name: Rotational thromboelastometry
description: 1.8 ml blood sample
arm group label: Patients undergoing THR with known bone neoplasm
arm group label: Patients undergoing THR with no known bone neoplasm
other name: ROTEM
Arterial blood samples
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jan Pluta, MD
role: Principal Investigator
affiliation: Medical University of Warsaw
last name: Marek Janiak, MD
phone: 0048225021724
email: mjaniak1@wum.edu.pl
facility: 
status: Recruiting
contact: 
country: Poland
responsible party type: Principal Investigator
investigator affiliation: Medical University of Warsaw
investigator full name: Jan Pluta
investigator title: Principal Investigator
mesh term: Neoplasms
mesh term: Bone Neoplasms
mesh term: Intraoperative Complications
sharing ipd: Undecided