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NCT Number: NCT05713630

The Use of Tranexamic Acid in the Treatment of Symptomatic Subdural Hematoma

Subdural hematoma (SDH) is a common condition experienced after head injury. Blood collects on the surface of the brain, causing headaches which can progress to confusion, weakness, or even coma. While patients with SDH often receive surgery, not all patients require surgery right away to ease pressure on the brain. After surgery, there can be up to 30 percent chance of more bleeding and the need for more surgeries. Given this, a drug capable of lowering the chance of more bleeding and speeding the recovery of the patient is highly desirable. In this study, we will test a commonly used, cheap drug called Tranexamic Acid (TXA). While the body stops unwanted and sometimes dangerous bleeding naturally by forming blood clots, TXA stops these blood clots from breaking down, which helps to keep bleeding spots plugged. Our previous study showed that TXA helped speed up patients' recovery; but a larger number of patients is necessary to evaluate how well TXA works to reduce bleeding and improve patient-reported outcomes. In this study, regardless of the need for surgery, half of the patients will be randomly assigned to take TXA, while the other half will take a placebo, which is a look-alike substance that contains no active drug. We will measure multiple outcomes over time to determine if TXA is working and lowers healthcare and personal costs, while also taking blood and surgical samples, to better understand how this drug works in SDH patients.

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Key information

Conditions

Subdural Hematoma Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Craniocerebral Trauma Hematoma Hematoma, Subdural Hemorrhage Intracranial Hemorrhage, Traumatic Intracranial Hemorrhages Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Trauma, Nervous System Vascular Diseases Wounds and Injuries

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients aged 45 and older weighing between 45-150 kg diagnosed with symptomatic SDH will be included. SDH is defined as unilateral or bilateral crescentic collection of blood (hyper, iso, or hypodense, or mixed density) of greater than or equals to 8 mm in thickness along the cerebral convexity on CT of the head. Symptomatic SDH patients eligible for inclusion are those with SDH with one or more of the following symptoms attributable to the SDH: headache, gait disturbance, confusion or cognitive decline, limb weakness or numbness/paresthesia, speech or visual disturbance, drowsiness or impaired consciousness, seizures, impaired cognition, or memory loss at the time of assessment.

Exclusion criteria

  • Patients will be excluded for any of the following conditions:
  • Asymptomatic for longer than 72 hours
  • SDH less than 8 mm in maximal thickness
  • Have an acutely deteriorating neurological status (e.g., brain herniation with pupillary dilation, aneurysm rupture, etc.) that is likely to be fatal within 6 hours or less due to a predominantly acute SDH
  • Presence of brain contusion larger than 5 cubic centimeters or subarachnoid hemorrhage (SAH) thicker than 10 mm with Glasgow Coma Scale (GCS)< 13
  • Patients with primarily interhemispheric or tentorial SDH
  • Hypersensitivity to TXA or any of the placebo ingredients
  • Pregnancy
  • Irregular menstrual bleeding with unidentified cause
  • Known acquired colour vision disturbances
  • Hematuria caused by renal parenchymal disease
  • Acute and chronic renal insufficiency indicated by estimated Glomerular Filtration Rate (eGFR) ≤ 30 mL/min
  • Concomitant intake of birth control pill and/or hormonal replacement therapy, and anti-inhibitor coagulant concentrates (factor VIII inhibitor bypass activity (FEIBA), factor VII, activated factor IX)
  • Consumption coagulopathy/disseminated intravascular coagulation (DIC) in the last 7 days
  • Not competent to take study medication properly and regularly or not having access to caregiver that is able to comply with study medication administration
  • Mechanical heart valve
  • Liver cirrhosis
  • Recent venous and/or arterial thromboembolism within 6 months of study enrolment
  • SDH caused by intracranial hypotension
  • Known thrombophilia (e.g., antiphospholipid syndrome)
  • Any active malignancy: metastatic cancer systemically or to the brain or a primary malignant brain tumour treated within the last 6 months
  • Previous enrolment in this trial for a prior episode
  • Time interval >3 days from the time of clinical assessment to eligibility assessment
  • Patients weighing <45 kg or >150 kg
  • Patients received any amount of TXA upon admittance to hospital prior to enrolment

Treatment and study plan

Tranexamic acid (TXA)

Drug

Marcan-Tranexamic Acid 500 mg oral tablet over-encapsulated to match the placebo. Sandoz-Tranexamic Acid 100 mg/mL solution for injection via intravenous (IV) added to a 100mL infusion bag of NaCl 0.9% and infused by slow intravenous injection over 20 minutes.

Other names: Cyklokapron

Placebo

Drug

Placebo 500 mg consisting of an identical capsule to over-encapsulated tranexamic acid oral tablet entirely filled with microcrystalline cellulose, and sealed. Placebo 100 mg/mL solution for injection via intravenous (IV) consisting of 0.9% sodium chloride (saline).

Primary outcomes

  1. European Quality of Life 5 Dimensions 5 Level Version (EQ-5D-5L)

    Time frame: Every 2 weeks after randomization up to 45±10 days.

    A self-rated questionnaire that assesses a patient's health state in five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.

Secondary outcomes

  1. Patient-Reported Outcomes Measurement Information System (PROMIS) Scale v1.2 - Global Health. English and French versions

    Time frame: Baseline and every 2 weeks after randomization up to 45±10 days, and then at 60-90 days, and 180±10 days after randomization.

    A 10-item measure that assesses an individual's general physical, mental, and social health as it is intended to globally reflect individuals' assessment of their physical and mental health in the last 7 days.

  2. PROMIS Item Bank v2.0 - Cognitive Function. English version

    Time frame: Baseline and every 2 weeks after randomization up to 45±10 days, and then at 60-90 days, and 180±10 days after randomization.

    A measure that assesses cognitive function that will be administered as a computer adaptive test.

  3. PROMIS Item Bank v2.0 - Physical Function. English version

    Time frame: Baseline and every 2 weeks after randomization up to 45±10 days, and then at 60-90 days, and 180±10 days after randomization.

    A measure that assesses self-reported capability rather than actual performance of physical activities that will be administered as a computer adaptive test.

  4. PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities. English version

    Time frame: Baseline and every 2 weeks after randomization up to 45±10 days, and then at 60-90 days, and 180±10 days after randomization.

    A measure that assesses the perceived ability to perform one's usual social roles and activities that will be administered as a computer adaptive test. The item bank does not use a time frame (e.g. over the past 7 days) when assessing ability to participate in social roles and activities.

  5. Subdural hematoma volume change

    Time frame: Baseline, 45±10 days after randomization, and 60-90 days if deemed necessary for the patient's routine care.

    Change in hematoma volume in millilitres on CT scan.

  6. Number of subdural hematoma-related surgical interventions

    Time frame: First admission, subsequent admissions up to 180 days after randomization

  7. Recurrence rate of SDH

    Time frame: 45±10 days, 60-90 days, and 180±10 days after randomization

  8. Mortality

    Time frame: During the course of study up to 180±10 days after randomization

  9. Modified Rankin Scale

    Time frame: Baseline, 45±10 days, 60-90 days, and 180±10 days after randomization

    A 6-point disability scale used to measure the degree of disability in patients who have had a stroke.

  10. Disability Rating Scale

    Time frame: Baseline, 45±10 days, 60-90 days, and 180±10 days after randomization

    Eight questions regarding body function, activity, participation, communication, and movements each rated on a 3-5-point scale that is summed to give a total score.

  11. Montreal Cognitive Assessment

    Time frame: Baseline, 45±10 days, and 60-90 days after randomization

    This assessment evaluates the patient's cognition based on eight areas: visuospatial/executive function, naming, memory, attention, language, abstraction, delayed recall, and orientation.

  12. Medical Consumption Questionnaire

    Time frame: Baseline, 45±10 days, and 180±10 days after randomization

    Health-related cost questionnaire on the use of healthcare in the past month.

  13. EQ-5D-5L

    Time frame: Baseline, 60-90 days, and 180±10 days after randomization

    A self-rated questionnaire that assesses a patient's health state in five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.

  14. Adverse events

    Time frame: Discharge, 45±10 days, 60-90 days, and 180±10 days after randomization

    Adverse events of grade 3 or higher as defined by Good Clinical Practice Guidelines.

  15. Length of stay in hospital due to subdural hematoma

    Time frame: During the course of the study up to 180±10 days after randomization

  16. Disposition after discharged from hospital

    Time frame: During the course of the study up to 180±10 days after randomization

  17. Groningen Frailty Indicator

    Time frame: Baseline and 45±10 days after randomization.

    A 15-item questionnaire assessing mobility, vision, hearing, nutrition, comorbidity, cognition, psychosocial and physical well-being. Each item is scored dichotomously, with a value of 1 assigned when a deficit is present.

Study contacts

Contact information is provided by the study sponsor or research team.

Melissa C Fazari, MSc

CONTACT

[email protected]

437-655-1471

Michael D Cusimano, MD, PhD

CONTACT

[email protected]

416-864-5312

Sponsors and collaborators

Lead sponsor

Unity Health Toronto

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)
  • The Physicians' Services Incorporated Foundation

Registry information

Official study title

TRACE STUDY: A Randomized Controlled Trial Using Tranexamic Acid in the Treatment of Subdural Hematoma

Acronym: TRACE

Important dates

Study start
2026
Primary completion
2027
Study completion
2030
First posted
Feb 6, 2023
Registry last updated
May 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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