<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/NCT03044184</url>
  </required_header>
  <id_info>
    <org_study_id>KwongWH</org_study_id>
    <nct_id>NCT03044184</nct_id>
  </id_info>
  <brief_title>Tranexamic Acid for Spontaneous Acute Cerebral Hemorrhage Trial</brief_title>
  <acronym>TRANSACT</acronym>
  <official_title>Randomized, Double-blind, Placebo-controlled Trial to Investigate the Effectiveness of Early Intravenous Tranexamic Acid in Limiting Hematoma Expansion in Patients With Spontaneous Intracerebral Hemorrhage</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kwong Wah Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kwong Wah Hospital</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims to explore the effectiveness of tranexamic acid (also known as trans amine or&#xD;
      TXA) in reducing hematoma expansion in patients with hemorrhagic stroke when given in the&#xD;
      acute phase.&#xD;
&#xD;
      METHODOLOGY&#xD;
&#xD;
      This will be a Phase III, parallel-group double-blind randomised placebo control trial.&#xD;
      Patients allocated to the control group will receive standard care for hemorrhagic stroke&#xD;
      according to the 2015 American Heart Association guidelines. Patients allocated to the&#xD;
      intervention group will receive, in addition to standard care, a loading dose of intravenous&#xD;
      TXA 1gm within 3 hours of symptom onset followed by a 1gm maintenance dose over 8 hours.&#xD;
      Timing and dosing are in accordance to previous established study protocols. Patients in the&#xD;
      intervention group will only receive a single treatment course of TXA.&#xD;
&#xD;
      Study subjects will be identified by either the on-duty clinicians from the Department of&#xD;
      Neurosurgery of this institution or by the study investigators. Should the patient meet study&#xD;
      eligibility criteria consent will be obtained either from the patient or from his/her next of&#xD;
      kin. 1:1 block randomization will be performed by a remote internet randomization service by&#xD;
      accessing a website. Patients allocated to the intervention arm will have 1gm of TXA added to&#xD;
      100ml of normal saline (0.9%) infused over 10 minutes as a loading dose. This is then&#xD;
      followed by a maintenance dose of 1gm of TXA in 500ml of intravenous isotonic solution&#xD;
      infused at 120mg/hour (60ml/hour) for 8 hours. Patient's allocated to the control arm will&#xD;
      have an equal volume of normal saline (0.9%) infused as a placebo. The patient and the&#xD;
      outcome assessor will be blinded to study group allocation.&#xD;
&#xD;
      The primary endpoint of this study will be to assess the percentage change in brain blood&#xD;
      clot volume by computed tomography brain scans on admission, 6 hours later, at 24 hours and&#xD;
      at 1 week.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      INTRODUCTION&#xD;
&#xD;
      There are very few treatment options for patients with spontaneous intracerebral hemorrhage,&#xD;
      a type of hemorrhagic stroke especially prevalent among Chinese, during the acute phase.&#xD;
      Blood clot expansion in the brain (hematoma expansion; HE) is one of the most significant&#xD;
      predictors for poor outcome in such patients.&#xD;
&#xD;
      Tranexamic acid (TXA) is a commonly used medication available in all acute Hospital Authority&#xD;
      hospitals prescribed for a variety of conditions when bleeding occurs, for example epistaxis&#xD;
      and menorrhagia. Intravenous administration of TXA has been proven to benefit severe trauma&#xD;
      patients by reducing mortality and also preventing the recurrent rupture of brain aneurysms&#xD;
      in another type of hemorrhagic stroke. The medication is safe and has been proven to improve&#xD;
      outcomes in these patients.&#xD;
&#xD;
      A previously performed pilot study exploring the safety and feasibility of administrating&#xD;
      intravenous TXA to patients with hemorrhagic stroke was recently performed and concluded the&#xD;
      medication's safety. There was also a trend to significance for reducing the percentage&#xD;
      change of hematoma volume in patients who received TXA.&#xD;
&#xD;
      This study aims to explore the effectiveness of TXA in reducing hematoma expansion in&#xD;
      patients with hemorrhagic stroke when given in the acute phase.&#xD;
&#xD;
      METHODOLOGY&#xD;
&#xD;
      This will be a Phase III, parallel-group double-blind randomised placebo control trial.&#xD;
      Patients allocated to the control group will receive standard care for hemorrhagic stroke&#xD;
      according to the 2015 American Heart Association guidelines. Patients allocated to the&#xD;
      intervention group will receive, in addition to standard care, a loading dose of intravenous&#xD;
      TXA 1gm within 3 hours of symptom onset followed by a 1gm maintenance dose over 8 hours.&#xD;
      Timing and dosing are in accordance to previous established study protocols. Patients in the&#xD;
      intervention group will only receive a single treatment course of TXA.&#xD;
&#xD;
      Study subjects will be identified by either the on-duty clinicians from the Department of&#xD;
      Neurosurgery of this institution or by the study investigators. Should the patient meet study&#xD;
      eligibility criteria consent will be obtained either from the patient or from his/her next of&#xD;
      kin. 1:1 block randomization will be performed by a remote internet randomization service by&#xD;
      accessing a website. Patients allocated to the intervention arm will have 1gm of TXA added to&#xD;
      100ml of normal saline (0.9%) infused over 10 minutes as a loading dose. This is then&#xD;
      followed by a maintenance dose of 1gm of TXA in 500ml of intravenous isotonic solution&#xD;
      infused at 120mh/hour (60ml/hour) for 8 hours. Patient's allocated to the control arm will&#xD;
      have an equal volume of isotonic solution infused as a placebo. The patient and the outcome&#xD;
      assessor will be blinded to study group allocation.&#xD;
&#xD;
      The primary endpoint of this study will be to assess the percentage change in brain blood&#xD;
      clot volume by computed tomography brain scans on admission, 6 hours later, at 24 hours and&#xD;
      at 1 week. Volumetric analysis of the brain scans will be performed by two radiologists&#xD;
      blinded to the patient's study group allocation..&#xD;
&#xD;
      Secondary endpoints will be assessed by a research assistant blinded to the patient's study&#xD;
      group allocation. One such endpoint is functional outcome in terms of the Glasgow Outcome&#xD;
      Scale and modified Rankin scale at 3 months and 6 months after stroke. Another secondary&#xD;
      endpoint is quality of life at 3 months and 6 months by adopting the Stroke-specific Quality&#xD;
      of Life Scale. Other secondary endpoints include death within 30 days of admission, vascular&#xD;
      occlusive events (myocardial infarction, pulmonary embolism, deep vein thrombosis), ischemic&#xD;
      stroke, seizures and other TXA-associated adverse effects.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">April 1, 2017</start_date>
  <completion_date type="Anticipated">December 31, 2020</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2020</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>
    <intervention_model_description>Randomised placebo-controlled parallel group clinical trial</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
    <masking_description>Intravenous normal saline or transamine will be administered to subjects. Both will be of equal volume, colour and in similar intravenous fluid packaging.&#xD;
The outcomes assessor will be unaware of the subject group allocation.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Intracerebral hematoma volume (by computed tomography brain scan) at 6 hours</measure>
    <time_frame>At 6 hours</time_frame>
    <description>Intracerebral hematoma volume (ml) as assessed by CT brain scan.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Intracerebral hematoma volume (by computed tomography brain scan) at 24 hours</measure>
    <time_frame>At 24 hours</time_frame>
    <description>Intracerebral hematoma volume (ml) as assessed by CT brain scan.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Intracerebral hematoma volume (by computed tomography brain scan) at 1 week</measure>
    <time_frame>At 1 week</time_frame>
    <description>Intracerebral hematoma volume (ml) as assessed by CT brain scan.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Glasgow outcome score</measure>
    <time_frame>At 3-months and 6 months after stroke</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Modified Rankin score</measure>
    <time_frame>At 3-months and 6 months after stroke</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stroke-specific quality of life scale</measure>
    <time_frame>At 3-months and 6 months after stroke</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>30-day mortality</measure>
    <time_frame>At 30 days after admission or until time of death within 30 days</time_frame>
    <description>All-cause mortality within 30 days of admission</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vascular occlusive events</measure>
    <time_frame>At 30 days after admission</time_frame>
    <description>Ischemic stroke, myocardial infarction, pulmonary embolism, deep vein thrombosis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of seizures</measure>
    <time_frame>At 30 days after stroke</time_frame>
    <description>Rate of seizures within 30 days of stroke</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tranexamic acid-associated adverse effects</measure>
    <time_frame>At 30 days after admission</time_frame>
    <description>Intolerable gastrointestinal symptoms such as dyspepsia, diarrhea, vomiting.&#xD;
Allergic reaction to TXA.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Need for neurosurgical intervention</measure>
    <time_frame>At 30 days after admission</time_frame>
    <description>Need for operative management of the hemorrhagic stroke</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">220</enrollment>
  <condition>Stroke Hemorrhagic</condition>
  <condition>Intracerebral Haemorrhage</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Standard management for patients with spontaneous intracerebral hemorrhage according to 2015 AHA/ASA Guidelines for the Management of Intracerebral Hemorrhage&#xD;
AND&#xD;
Patients will have 1gram of tranexamic acid (diluted in 100ml of normal saline 0.9%) intravenously infused over 10 minutes within 3 hours of symptom presentation and another 1 gram of tranexamic acid (diluted in 100ml of normal saline 0.9%) infused over 8 hours.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Standard management for patients with spontaneous intracerebral hemorrhage according to 2015 AHA/ASA Guidelines for the Management of Intracerebral Hemorrhage&#xD;
AND&#xD;
Patients will 100ml of normal saline 0.9% intravenously infused over 10 minutes within 3 hours of symptom presentation and another 100ml of normal saline 0.9% infused over 8 hours.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tranexamic Acid</intervention_name>
    <description>Transamine is an antifibrinolytic medication given systemically via the intravenous route</description>
    <arm_group_label>Intervention</arm_group_label>
    <other_name>Transamine</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients with CT evidence of supratentorial intracerebral hemorrhage&#xD;
&#xD;
          2. Initiation of trial medication within 3 hours from the time of symptoms onset.&#xD;
&#xD;
          3. Ethnic Chinese&#xD;
&#xD;
          4. Reasonable expectation of completion of outcome measures at follow-up&#xD;
&#xD;
          5. Written informed consent from either the patient or next-of-kin or legal guardian.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients not expected to survive 24 hours after admission.&#xD;
&#xD;
          2. Patients with brainstem herniation syndrome on admission.&#xD;
&#xD;
          3. Patients who need immediate neurosurgical intervention.&#xD;
&#xD;
          4. GCS of of 5 or less on admission i.e. a GCS score of 2 according to the Hemphil ICH&#xD;
             score1.&#xD;
&#xD;
          5. Previous antiplatelet and anticoagulant medication use.&#xD;
&#xD;
          6. Known thrombocytopenia or coagulopathy.&#xD;
&#xD;
          7. Disseminated intravascular coagulation on admission.&#xD;
&#xD;
          8. Acute sepsis on admission.&#xD;
&#xD;
          9. Intracerebral hemorrhage (ICH) secondary to intracranial vascular lesion: aneurysm,&#xD;
             arteriovenous malformation, neoplasm or dural venous sinus thrombosis.&#xD;
&#xD;
         10. Previous venous thromboembolic disease : deep venous thrombosis.&#xD;
&#xD;
         11. History of ischemic stroke or transient ischemic attack within 12 months.&#xD;
&#xD;
         12. History of ischemic heart disease or myocardial infarction.&#xD;
&#xD;
         13. History of peripheral vascular disease.&#xD;
&#xD;
         14. Patients with previous disability (prestroke modified Rankin scale score &gt;2)&#xD;
&#xD;
         15. Pregnancy or breast feeding.&#xD;
&#xD;
         16. History of allergy to tranexamic acid&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Peter YM Woo, FRCS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Neurosurgery, Kwong Wah Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Peter YM Woo, FRCS</last_name>
    <phone>3517 5052</phone>
    <email>wym307@ha.org.hk</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Carmen Ho</last_name>
    <email>hoht@ha.org.hk</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Kwong Wah Hospital</name>
      <address>
        <city>Hong Kong</city>
        <country>Hong Kong</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Peter YM Woo, MBBS, FRCS</last_name>
      <phone>3517 5052</phone>
      <email>wym@ha.org.hk</email>
    </contact>
    <contact_backup>
      <last_name>Ho</last_name>
    </contact_backup>
  </location>
  <location_countries>
    <country>Hong Kong</country>
  </location_countries>
  <verification_date>October 2019</verification_date>
  <study_first_submitted>January 26, 2017</study_first_submitted>
  <study_first_submitted_qc>February 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 6, 2017</study_first_posted>
  <last_update_submitted>October 15, 2019</last_update_submitted>
  <last_update_submitted_qc>October 15, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 17, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Kwong Wah Hospital</investigator_affiliation>
    <investigator_full_name>Peter Woo Yat Ming</investigator_full_name>
    <investigator_title>Doctor</investigator_title>
  </responsible_party>
  <keyword>Tranexamic Acid</keyword>
  <keyword>Antifibrinolytic</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cerebral Hemorrhage</mesh_term>
    <mesh_term>Hemorrhagic Stroke</mesh_term>
    <mesh_term>Hemorrhage</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tranylcypromine</mesh_term>
    <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/NCT03044184
org study id: KwongWH
nct id: NCT03044184
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
This study aims to explore the effectiveness of tranexamic acid (also known as trans amine or
      TXA) in reducing hematoma expansion in patients with hemorrhagic stroke when given in the
      acute phase.

      METHODOLOGY

      This will be a Phase III, parallel-group double-blind randomised placebo control trial.
      Patients allocated to the control group will receive standard care for hemorrhagic stroke
      according to the 2015 American Heart Association guidelines. Patients allocated to the
      intervention group will receive, in addition to standard care, a loading dose of intravenous
      TXA 1gm within 3 hours of symptom onset followed by a 1gm maintenance dose over 8 hours.
      Timing and dosing are in accordance to previous established study protocols. Patients in the
      intervention group will only receive a single treatment course of TXA.

      Study subjects will be identified by either the on-duty clinicians from the Department of
      Neurosurgery of this institution or by the study investigators. Should the patient meet study
      eligibility criteria consent will be obtained either from the patient or from his/her next of
      kin. 1:1 block randomization will be performed by a remote internet randomization service by
      accessing a website. Patients allocated to the intervention arm will have 1gm of TXA added to
      100ml of normal saline (0.9%) infused over 10 minutes as a loading dose. This is then
      followed by a maintenance dose of 1gm of TXA in 500ml of intravenous isotonic solution
      infused at 120mg/hour (60ml/hour) for 8 hours. Patient's allocated to the control arm will
      have an equal volume of normal saline (0.9%) infused as a placebo. The patient and the
      outcome assessor will be blinded to study group allocation.

      The primary endpoint of this study will be to assess the percentage change in brain blood
      clot volume by computed tomography brain scans on admission, 6 hours later, at 24 hours and
      at 1 week.
INTRODUCTION

      There are very few treatment options for patients with spontaneous intracerebral hemorrhage,
      a type of hemorrhagic stroke especially prevalent among Chinese, during the acute phase.
      Blood clot expansion in the brain (hematoma expansion; HE) is one of the most significant
      predictors for poor outcome in such patients.

      Tranexamic acid (TXA) is a commonly used medication available in all acute Hospital Authority
      hospitals prescribed for a variety of conditions when bleeding occurs, for example epistaxis
      and menorrhagia. Intravenous administration of TXA has been proven to benefit severe trauma
      patients by reducing mortality and also preventing the recurrent rupture of brain aneurysms
      in another type of hemorrhagic stroke. The medication is safe and has been proven to improve
      outcomes in these patients.

      A previously performed pilot study exploring the safety and feasibility of administrating
      intravenous TXA to patients with hemorrhagic stroke was recently performed and concluded the
      medication's safety. There was also a trend to significance for reducing the percentage
      change of hematoma volume in patients who received TXA.

      This study aims to explore the effectiveness of TXA in reducing hematoma expansion in
      patients with hemorrhagic stroke when given in the acute phase.

      METHODOLOGY

      This will be a Phase III, parallel-group double-blind randomised placebo control trial.
      Patients allocated to the control group will receive standard care for hemorrhagic stroke
      according to the 2015 American Heart Association guidelines. Patients allocated to the
      intervention group will receive, in addition to standard care, a loading dose of intravenous
      TXA 1gm within 3 hours of symptom onset followed by a 1gm maintenance dose over 8 hours.
      Timing and dosing are in accordance to previous established study protocols. Patients in the
      intervention group will only receive a single treatment course of TXA.

      Study subjects will be identified by either the on-duty clinicians from the Department of
      Neurosurgery of this institution or by the study investigators. Should the patient meet study
      eligibility criteria consent will be obtained either from the patient or from his/her next of
      kin. 1:1 block randomization will be performed by a remote internet randomization service by
      accessing a website. Patients allocated to the intervention arm will have 1gm of TXA added to
      100ml of normal saline (0.9%) infused over 10 minutes as a loading dose. This is then
      followed by a maintenance dose of 1gm of TXA in 500ml of intravenous isotonic solution
      infused at 120mh/hour (60ml/hour) for 8 hours. Patient's allocated to the control arm will
      have an equal volume of isotonic solution infused as a placebo. The patient and the outcome
      assessor will be blinded to study group allocation.

      The primary endpoint of this study will be to assess the percentage change in brain blood
      clot volume by computed tomography brain scans on admission, 6 hours later, at 24 hours and
      at 1 week. Volumetric analysis of the brain scans will be performed by two radiologists
      blinded to the patient's study group allocation..

      Secondary endpoints will be assessed by a research assistant blinded to the patient's study
      group allocation. One such endpoint is functional outcome in terms of the Glasgow Outcome
      Scale and modified Rankin scale at 3 months and 6 months after stroke. Another secondary
      endpoint is quality of life at 3 months and 6 months by adopting the Stroke-specific Quality
      of Life Scale. Other secondary endpoints include death within 30 days of admission, vascular
      occlusive events (myocardial infarction, pulmonary embolism, deep vein thrombosis), ischemic
      stroke, seizures and other TXA-associated adverse effects.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomised placebo-controlled parallel group clinical trial
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
masking description: Intravenous normal saline or transamine will be administered to subjects. Both will be of equal volume, colour and in similar intravenous fluid packaging.
The outcomes assessor will be unaware of the subject group allocation.
measure: Intracerebral hematoma volume (by computed tomography brain scan) at 6 hours
time frame: At 6 hours
description: Intracerebral hematoma volume (ml) as assessed by CT brain scan.
measure: Intracerebral hematoma volume (by computed tomography brain scan) at 24 hours
time frame: At 24 hours
description: Intracerebral hematoma volume (ml) as assessed by CT brain scan.
measure: Intracerebral hematoma volume (by computed tomography brain scan) at 1 week
time frame: At 1 week
description: Intracerebral hematoma volume (ml) as assessed by CT brain scan.
measure: Glasgow outcome score
time frame: At 3-months and 6 months after stroke
measure: Modified Rankin score
time frame: At 3-months and 6 months after stroke
measure: Stroke-specific quality of life scale
time frame: At 3-months and 6 months after stroke
measure: 30-day mortality
time frame: At 30 days after admission or until time of death within 30 days
description: All-cause mortality within 30 days of admission
measure: Vascular occlusive events
time frame: At 30 days after admission
description: Ischemic stroke, myocardial infarction, pulmonary embolism, deep vein thrombosis
measure: Rate of seizures
time frame: At 30 days after stroke
description: Rate of seizures within 30 days of stroke
measure: Tranexamic acid-associated adverse effects
time frame: At 30 days after admission
description: Intolerable gastrointestinal symptoms such as dyspepsia, diarrhea, vomiting.
Allergic reaction to TXA.
measure: Need for neurosurgical intervention
time frame: At 30 days after admission
description: Need for operative management of the hemorrhagic stroke
arm group label: Intervention
arm group type: Active Comparator
description: Standard management for patients with spontaneous intracerebral hemorrhage according to 2015 AHA/ASA Guidelines for the Management of Intracerebral Hemorrhage
AND
Patients will have 1gram of tranexamic acid (diluted in 100ml of normal saline 0.9%) intravenously infused over 10 minutes within 3 hours of symptom presentation and another 1 gram of tranexamic acid (diluted in 100ml of normal saline 0.9%) infused over 8 hours.
arm group label: Control
arm group type: No Intervention
description: Standard management for patients with spontaneous intracerebral hemorrhage according to 2015 AHA/ASA Guidelines for the Management of Intracerebral Hemorrhage
AND
Patients will 100ml of normal saline 0.9% intravenously infused over 10 minutes within 3 hours of symptom presentation and another 100ml of normal saline 0.9% infused over 8 hours.
intervention type: Drug
intervention name: Tranexamic Acid
description: Transamine is an antifibrinolytic medication given systemically via the intravenous route
arm group label: Intervention
other name: Transamine
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Peter YM Woo, FRCS
role: Principal Investigator
affiliation: Neurosurgery, Kwong Wah Hospital
last name: Peter YM Woo, FRCS
phone: 3517 5052
email: wym307@ha.org.hk
last name: Carmen Ho
email: hoht@ha.org.hk
facility: 
status: Recruiting
contact: 
contact backup: 
country: Hong Kong
responsible party type: Principal Investigator
investigator affiliation: Kwong Wah Hospital
investigator full name: Peter Woo Yat Ming
investigator title: Doctor
mesh term: Cerebral Hemorrhage
mesh term: Hemorrhagic Stroke
mesh term: Hemorrhage
mesh term: Tranylcypromine
mesh term: Tranexamic Acid
sharing ipd: Undecided