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Tranexamic Acid for Spontaneous Acute Cerebral Hemorrhage Trial (TRANSACT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03044184
Recruitment Status : Recruiting
First Posted : February 6, 2017
Last Update Posted : October 17, 2019
Sponsor:
Information provided by (Responsible Party):
Peter Woo Yat Ming, Kwong Wah Hospital

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Stroke Hemorrhagic Intracerebral Haemorrhage Drug: Tranexamic Acid Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomised placebo-controlled parallel group clinical trial
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.

Primary Purpose: Treatment
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
Actual Study Start Date : April 1, 2017
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Arm Intervention/treatment
Active Comparator: Intervention

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.

Drug: Tranexamic Acid
Transamine is an antifibrinolytic medication given systemically via the intravenous route
Other Name: Transamine

No Intervention: Control

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.




Primary Outcome Measures :
  1. Intracerebral hematoma volume (by computed tomography brain scan) at 6 hours [ Time Frame: At 6 hours ]
    Intracerebral hematoma volume (ml) as assessed by CT brain scan.

  2. Intracerebral hematoma volume (by computed tomography brain scan) at 24 hours [ Time Frame: At 24 hours ]
    Intracerebral hematoma volume (ml) as assessed by CT brain scan.

  3. Intracerebral hematoma volume (by computed tomography brain scan) at 1 week [ Time Frame: At 1 week ]
    Intracerebral hematoma volume (ml) as assessed by CT brain scan.


Secondary Outcome Measures :
  1. Glasgow outcome score [ Time Frame: At 3-months and 6 months after stroke ]
  2. Modified Rankin score [ Time Frame: At 3-months and 6 months after stroke ]
  3. Stroke-specific quality of life scale [ Time Frame: At 3-months and 6 months after stroke ]
  4. 30-day mortality [ Time Frame: At 30 days after admission or until time of death within 30 days ]
    All-cause mortality within 30 days of admission

  5. Vascular occlusive events [ Time Frame: At 30 days after admission ]
    Ischemic stroke, myocardial infarction, pulmonary embolism, deep vein thrombosis

  6. Rate of seizures [ Time Frame: At 30 days after stroke ]
    Rate of seizures within 30 days of stroke

  7. Tranexamic acid-associated adverse effects [ Time Frame: At 30 days after admission ]
    1. Intolerable gastrointestinal symptoms such as dyspepsia, diarrhea, vomiting.
    2. Allergic reaction to TXA.

  8. Need for neurosurgical intervention [ Time Frame: At 30 days after admission ]
    Need for operative management of the hemorrhagic stroke



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with CT evidence of supratentorial intracerebral hemorrhage
  2. Initiation of trial medication within 3 hours from the time of symptoms onset.
  3. Ethnic Chinese
  4. Reasonable expectation of completion of outcome measures at follow-up
  5. Written informed consent from either the patient or next-of-kin or legal guardian.

Exclusion Criteria:

  1. Patients not expected to survive 24 hours after admission.
  2. Patients with brainstem herniation syndrome on admission.
  3. Patients who need immediate neurosurgical intervention.
  4. GCS of of 5 or less on admission i.e. a GCS score of 2 according to the Hemphil ICH score1.
  5. Previous antiplatelet and anticoagulant medication use.
  6. Known thrombocytopenia or coagulopathy.
  7. Disseminated intravascular coagulation on admission.
  8. Acute sepsis on admission.
  9. Intracerebral hemorrhage (ICH) secondary to intracranial vascular lesion: aneurysm, arteriovenous malformation, neoplasm or dural venous sinus thrombosis.
  10. Previous venous thromboembolic disease : deep venous thrombosis.
  11. History of ischemic stroke or transient ischemic attack within 12 months.
  12. History of ischemic heart disease or myocardial infarction.
  13. History of peripheral vascular disease.
  14. Patients with previous disability (prestroke modified Rankin scale score >2)
  15. Pregnancy or breast feeding.
  16. History of allergy to tranexamic acid

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03044184


Contacts
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Contact: Peter YM Woo, FRCS 3517 5052 wym307@ha.org.hk
Contact: Carmen Ho hoht@ha.org.hk

Locations
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Hong Kong
Kwong Wah Hospital Recruiting
Hong Kong, Hong Kong
Contact: Peter YM Woo, MBBS, FRCS    3517 5052    wym@ha.org.hk   
Contact: Ho         
Sponsors and Collaborators
Kwong Wah Hospital
Investigators
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Principal Investigator: Peter YM Woo, FRCS Neurosurgery, Kwong Wah Hospital

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Responsible Party: Peter Woo Yat Ming, Doctor, Kwong Wah Hospital
ClinicalTrials.gov Identifier: NCT03044184    
Other Study ID Numbers: KwongWH
First Posted: February 6, 2017    Key Record Dates
Last Update Posted: October 17, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Peter Woo Yat Ming, Kwong Wah Hospital:
Tranexamic Acid
Antifibrinolytic
Additional relevant MeSH terms:
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Cerebral Hemorrhage
Hemorrhage
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Tranylcypromine
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants
Antidepressive Agents
Psychotropic Drugs
Monoamine Oxidase Inhibitors
Enzyme Inhibitors
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs