<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/NCT03280212</url>
  </required_header>
  <id_info>
    <org_study_id>14-0176-GAP</org_study_id>
    <nct_id>NCT03280212</nct_id>
  </id_info>
  <brief_title>Tranexamic Acid in the Treatment of Residual Chronic Subdural Hematoma</brief_title>
  <acronym>TRACE</acronym>
  <official_title>Tranexamic Acid in the Treatment of Residual Chronic Subdural Hematoma: A Single-centre, Observer-blinded, Randomized Controlled Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Unity Health Toronto</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Unity Health Toronto</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Chronic subdural hematoma (CSDH) is a common disease after minor head trauma, especially in&#xD;
      elderly patients. This medical condition is characterized by blood collection in the subdural&#xD;
      space, which can result in severe neurological impairment. Current standard of care is the&#xD;
      evacuation of the CSDH by means of different surgical approaches. Although clinical and&#xD;
      surgical outcomes are satisfying in most cases, considerable morbidity and mortality as well&#xD;
      as recurrence rates of 3-31% are frequently reported. Therefore a non-surgical approach for&#xD;
      the treatment of CSDH would be desirable. Tranexamic acid (TXA), an antifibrinolytic drug has&#xD;
      been shown to decrease hematoma volume in a small cohort of patients suffering from CSDH. The&#xD;
      present study is designed to test the hypothesis that TXA can reduce the volume of CSDH.&#xD;
      Volume measurements of residual CSDH after burr-hole surgery will be performed during study&#xD;
      course to quantify treatment success. The trial is designed as a randomized controlled pilot&#xD;
      study, where half of the patients will be assigned to daily intake of TXA, whereas the other&#xD;
      half will receive medical treatment according to current practice without TXA prescription.&#xD;
      The primary endpoint of the study is defined as volume change in milliliters (mL) after 4-8&#xD;
      weeks of treatment. Secondary endpoints are hematoma volume change at 8-12 weeks, the rate of&#xD;
      patients with resolution of the CSDH after 4-8 weeks and 8-12 weeks days, as well as the rate&#xD;
      of reoperation during study course due to hematoma extension and neurological deterioration.&#xD;
      Additionally the neurological outcome and the drug compatibility will be estimated as&#xD;
      secondary objectives.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">March 6, 2017</start_date>
  <completion_date type="Anticipated">March 2018</completion_date>
  <primary_completion_date type="Anticipated">March 2018</primary_completion_date>
  <phase>Phase 3</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 (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Chronic subdural hematoma volume change</measure>
    <time_frame>4-8 weeks, 8-12 weeks</time_frame>
    <description>Change in hematoma volume in mL according to volume measurements made on CT scans comparing CT scan at 4-8 weeks to immediate post-operative CT scan.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Neurological outcome</measure>
    <time_frame>4-8 weeks, 8-12 weeks</time_frame>
    <description>An assessment of neurological outcome as measured by the National Institutes of Health Stroke Scale (NIHSS)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life</measure>
    <time_frame>4-8 weeks, 8-12 weeks</time_frame>
    <description>Participants quality of life as measured on the Health Utilities Index (HUI).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life</measure>
    <time_frame>4-8 weeks, 8-12 weeks</time_frame>
    <description>Participants quality of life as measured on the 36-item Short Form Health Survey (SF-36).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Occurrence of adverse events</measure>
    <time_frame>4-8 weeks, 8-12 weeks</time_frame>
    <description>Safety of the TXA dose regimen by monitoring incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Chronic Subdural Hematoma</condition>
  <arm_group>
    <arm_group_label>Tranexamic Acid Arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Tranexamic Acid 500 milligrams (MG)&#xD;
Participants of the Tranexamic Acid (TXA) arm will receive the study drug, TXA. Participants of average body weight (60-100kg) will receive TXA according to a 500mg three times daily (TID) dose regimen. Weight deviations from this range will see dose adjustments as follows: participants &lt;60kg will receive 500mg two times daily (BID), and participants &gt;100kg will receive 1000mg BID.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Arm</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No intervention&#xD;
Participants in the control arm will not receive any additional intervention, medication, or placebo, and will serve as a comparative arm for the experimental arm.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tranexamic Acid 500 MG</intervention_name>
    <description>Tranexamic Acid 500mg oral tablets.</description>
    <arm_group_label>Tranexamic Acid Arm</arm_group_label>
    <other_name>TXA</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients diagnosed with chronic subdural hematoma, and have a planned or have received&#xD;
             a unilateral or bilateral burr-hole craniostomy or mini-craniotomy&#xD;
&#xD;
          -  Written informed consent (patient, power of attorney or substitute decision maker)&#xD;
&#xD;
          -  Competence to take study medication properly and regularly or access to care giver&#xD;
             that is able to comply with accurate study medication administration&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Hypersensitivity to TXA or any of the ingredients&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Irregular menstrual bleeding with unidentified cause&#xD;
&#xD;
          -  Acquired colour vision disturbances&#xD;
&#xD;
          -  Acute and chronic renal insufficiency indicated by glomerular filtration rate (GFR) ≤&#xD;
             30 mL/min&#xD;
&#xD;
          -  Hematuria, caused by diseases of renal parenchyma&#xD;
&#xD;
          -  Current alcohol abuse (as indicated by an Alcohol Use Disorders Identification Test&#xD;
             (AUDIT) score of 10 or higher) drug abuse, or recreational drug use&#xD;
&#xD;
          -  Concomitant intake of hormonal contraceptives, factor IX complex concentrates, and&#xD;
             anti-inhibitor coagulant concentrates (factor VII, activated factor IX)&#xD;
&#xD;
          -  Active, history, or increased risk of thrombotic events (including deep vein&#xD;
             thrombosis, pulmonary embolism, cerebral venous thrombosis, arterial thrombotic&#xD;
             events), symptomatic carotid stenosis, myocardial infarction, acute coronary syndrome,&#xD;
             coronary artery disease, or consumption coagulopathy within the past 2 years&#xD;
&#xD;
          -  History of angioplasty with cardiac stent placement or mechanical heart valve&#xD;
&#xD;
          -  Active or history of brain pathologies such as stroke (hemorrhagic and ischemic),&#xD;
             subarachnoid hemorrhage, or malignant brain tumors (glioma, metastasis and others) as&#xD;
             well as history of seizures within the past 2 years&#xD;
&#xD;
          -  Contraindication to stopping full therapeutic doses of non-acetylsalicylic acid (ASA)&#xD;
             antiplatelets, warfarin, rivaroxaban, apixaban, dabigatran, or other anticoagulant for&#xD;
             2 weeks after surgery&#xD;
&#xD;
          -  Patients requiring immediate revision surgery (as defined by attending surgeon)&#xD;
&#xD;
          -  Inability of oral drug intake or missing support to guarantee oral drug intake&#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>
  <overall_contact>
    <last_name>Adriana M Workewych, HBSc</last_name>
    <phone>416-864-5312</phone>
    <email>workewycha@smh.ca</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Stanley Zhang</last_name>
    <phone>416-864-5312</phone>
    <email>zhangsh@smh.ca</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>St. Michael's Hospital</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5B 1W8</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Adriana M Workewych, HBSc</last_name>
      <phone>416-864-5312</phone>
      <email>workewycha@smh.ca</email>
    </contact>
    <investigator>
      <last_name>Michael D Cusimano, Md, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 10, 2017</study_first_submitted>
  <study_first_submitted_qc>September 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 12, 2017</study_first_posted>
  <last_update_submitted>September 13, 2017</last_update_submitted>
  <last_update_submitted_qc>September 13, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 14, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Unity Health Toronto</investigator_affiliation>
    <investigator_full_name>Michael Cusimano</investigator_full_name>
    <investigator_title>Neurosurgeon</investigator_title>
  </responsible_party>
  <keyword>Chronic subdural hematoma</keyword>
  <keyword>Tranexamic acid</keyword>
  <keyword>TXA</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hematoma, Subdural</mesh_term>
    <mesh_term>Hematoma, Subdural, Chronic</mesh_term>
    <mesh_term>Hematoma</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tranexamic Acid</mesh_term>
  </intervention_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/NCT03280212
org study id: 14-0176-GAP
nct id: NCT03280212
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Chronic subdural hematoma (CSDH) is a common disease after minor head trauma, especially in
      elderly patients. This medical condition is characterized by blood collection in the subdural
      space, which can result in severe neurological impairment. Current standard of care is the
      evacuation of the CSDH by means of different surgical approaches. Although clinical and
      surgical outcomes are satisfying in most cases, considerable morbidity and mortality as well
      as recurrence rates of 3-31% are frequently reported. Therefore a non-surgical approach for
      the treatment of CSDH would be desirable. Tranexamic acid (TXA), an antifibrinolytic drug has
      been shown to decrease hematoma volume in a small cohort of patients suffering from CSDH. The
      present study is designed to test the hypothesis that TXA can reduce the volume of CSDH.
      Volume measurements of residual CSDH after burr-hole surgery will be performed during study
      course to quantify treatment success. The trial is designed as a randomized controlled pilot
      study, where half of the patients will be assigned to daily intake of TXA, whereas the other
      half will receive medical treatment according to current practice without TXA prescription.
      The primary endpoint of the study is defined as volume change in milliliters (mL) after 4-8
      weeks of treatment. Secondary endpoints are hematoma volume change at 8-12 weeks, the rate of
      patients with resolution of the CSDH after 4-8 weeks and 8-12 weeks days, as well as the rate
      of reoperation during study course due to hematoma extension and neurological deterioration.
      Additionally the neurological outcome and the drug compatibility will be estimated as
      secondary objectives.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Chronic subdural hematoma volume change
time frame: 4-8 weeks, 8-12 weeks
description: Change in hematoma volume in mL according to volume measurements made on CT scans comparing CT scan at 4-8 weeks to immediate post-operative CT scan.
measure: Neurological outcome
time frame: 4-8 weeks, 8-12 weeks
description: An assessment of neurological outcome as measured by the National Institutes of Health Stroke Scale (NIHSS)
measure: Quality of life
time frame: 4-8 weeks, 8-12 weeks
description: Participants quality of life as measured on the Health Utilities Index (HUI).
measure: Quality of life
time frame: 4-8 weeks, 8-12 weeks
description: Participants quality of life as measured on the 36-item Short Form Health Survey (SF-36).
measure: Occurrence of adverse events
time frame: 4-8 weeks, 8-12 weeks
description: Safety of the TXA dose regimen by monitoring incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
arm group label: Tranexamic Acid Arm
arm group type: Experimental
description: Tranexamic Acid 500 milligrams (MG)
Participants of the Tranexamic Acid (TXA) arm will receive the study drug, TXA. Participants of average body weight (60-100kg) will receive TXA according to a 500mg three times daily (TID) dose regimen. Weight deviations from this range will see dose adjustments as follows: participants <60kg will receive 500mg two times daily (BID), and participants >100kg will receive 1000mg BID.
arm group label: Control Arm
arm group type: No Intervention
description: No intervention
Participants in the control arm will not receive any additional intervention, medication, or placebo, and will serve as a comparative arm for the experimental arm.
intervention type: Drug
intervention name: Tranexamic Acid 500 MG
description: Tranexamic Acid 500mg oral tablets.
arm group label: Tranexamic Acid Arm
other name: TXA
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Adriana M Workewych, HBSc
phone: 416-864-5312
email: workewycha@smh.ca
last name: Stanley Zhang
phone: 416-864-5312
email: zhangsh@smh.ca
facility: 
status: Recruiting
contact: 
investigator: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: Unity Health Toronto
investigator full name: Michael Cusimano
investigator title: Neurosurgeon
mesh term: Hematoma, Subdural
mesh term: Hematoma, Subdural, Chronic
mesh term: Hematoma
mesh term: Tranexamic Acid
sharing ipd: Undecided