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Tranexamic Acid in the Treatment of Residual Chronic Subdural Hematoma (TRACE)

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. Read our disclaimer for details. Identifier: NCT03280212
Recruitment Status : Unknown
Verified September 2017 by Michael Cusimano, St. Michael's Hospital, Toronto.
Recruitment status was:  Recruiting
First Posted : September 12, 2017
Last Update Posted : September 14, 2017
Information provided by (Responsible Party):
Michael Cusimano, St. Michael's Hospital, Toronto

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Chronic Subdural Hematoma Drug: Tranexamic Acid 500 MG Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Tranexamic Acid in the Treatment of Residual Chronic Subdural Hematoma: A Single-centre, Observer-blinded, Randomized Controlled Trial.
Actual Study Start Date : March 6, 2017
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : March 2018

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Tranexamic Acid Arm

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.

Drug: Tranexamic Acid 500 MG
Tranexamic Acid 500mg oral tablets.
Other Name: TXA

No Intervention: Control Arm

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.

Primary Outcome Measures :
  1. Chronic subdural hematoma volume change [ Time Frame: 4-8 weeks, 8-12 weeks ]
    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.

Secondary Outcome Measures :
  1. Neurological outcome [ Time Frame: 4-8 weeks, 8-12 weeks ]
    An assessment of neurological outcome as measured by the National Institutes of Health Stroke Scale (NIHSS)

  2. Quality of life [ Time Frame: 4-8 weeks, 8-12 weeks ]
    Participants quality of life as measured on the Health Utilities Index (HUI).

  3. Quality of life [ Time Frame: 4-8 weeks, 8-12 weeks ]
    Participants quality of life as measured on the 36-item Short Form Health Survey (SF-36).

  4. Occurrence of adverse events [ Time Frame: 4-8 weeks, 8-12 weeks ]
    Safety of the TXA dose regimen by monitoring incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Patients diagnosed with chronic subdural hematoma, and have a planned or have received a unilateral or bilateral burr-hole craniostomy or mini-craniotomy
  • Written informed consent (patient, power of attorney or substitute decision maker)
  • Competence to take study medication properly and regularly or access to care giver that is able to comply with accurate study medication administration

Exclusion Criteria:

  • Hypersensitivity to TXA or any of the ingredients
  • Pregnancy
  • Irregular menstrual bleeding with unidentified cause
  • Acquired colour vision disturbances
  • Acute and chronic renal insufficiency indicated by glomerular filtration rate (GFR) ≤ 30 mL/min
  • Hematuria, caused by diseases of renal parenchyma
  • Current alcohol abuse (as indicated by an Alcohol Use Disorders Identification Test (AUDIT) score of 10 or higher) drug abuse, or recreational drug use
  • Concomitant intake of hormonal contraceptives, factor IX complex concentrates, and anti-inhibitor coagulant concentrates (factor VII, activated factor IX)
  • Active, history, or increased risk of thrombotic events (including deep vein thrombosis, pulmonary embolism, cerebral venous thrombosis, arterial thrombotic events), symptomatic carotid stenosis, myocardial infarction, acute coronary syndrome, coronary artery disease, or consumption coagulopathy within the past 2 years
  • History of angioplasty with cardiac stent placement or mechanical heart valve
  • Active or history of brain pathologies such as stroke (hemorrhagic and ischemic), subarachnoid hemorrhage, or malignant brain tumors (glioma, metastasis and others) as well as history of seizures within the past 2 years
  • Contraindication to stopping full therapeutic doses of non-acetylsalicylic acid (ASA) antiplatelets, warfarin, rivaroxaban, apixaban, dabigatran, or other anticoagulant for 2 weeks after surgery
  • Patients requiring immediate revision surgery (as defined by attending surgeon)
  • Inability of oral drug intake or missing support to guarantee oral drug intake

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 identifier (NCT number): NCT03280212

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Contact: Adriana M Workewych, HBSc 416-864-5312
Contact: Stanley Zhang 416-864-5312

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Canada, Ontario
St. Michael's Hospital Recruiting
Toronto, Ontario, Canada, M5B 1W8
Contact: Adriana M Workewych, HBSc    416-864-5312   
Principal Investigator: Michael D Cusimano, Md, PhD         
Sponsors and Collaborators
St. Michael's Hospital, Toronto
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Responsible Party: Michael Cusimano, Neurosurgeon, St. Michael's Hospital, Toronto Identifier: NCT03280212    
Other Study ID Numbers: 14-0176-GAP
First Posted: September 12, 2017    Key Record Dates
Last Update Posted: September 14, 2017
Last Verified: September 2017
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
Keywords provided by Michael Cusimano, St. Michael's Hospital, Toronto:
Chronic subdural hematoma
Tranexamic acid
Additional relevant MeSH terms:
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Hematoma, Subdural
Hematoma, Subdural, Chronic
Pathologic Processes
Intracranial Hemorrhage, Traumatic
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Vascular Diseases
Cardiovascular Diseases
Wounds and Injuries
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action