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NCT05713630 | NOT YET RECRUITING | Subdural Hematoma

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

Unity Health Toronto

Brief Summary:

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.

Condition or disease

Subdural Hematoma

Intervention/treatment

Tranexamic acid (TXA)

Placebo

Phase

PHASE3

Study Type : INTERVENTIONAL
Estimated Enrollment : 130 participants
Masking : TRIPLE
Masking Description : Research Assistant Research Coordinator
Primary Purpose : TREATMENT
Official Title : TRACE STUDY: a Randomized Controlled Trial Using Tranexamic Acid in the Treatment of Subdural Hematoma
Actual Study Start Date : 2025-06-01
Estimated Primary Completion Date : 2030-03-01
Estimated Study Completion Date : 2030-11-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 45 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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
    • 1. Asymptomatic for longer than 72 hours
    • 2. SDH less than 8 mm in maximal thickness
    • 3. 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
    • 4. Presence of brain contusion larger than 5 cubic centimeters or subarachnoid hemorrhage (SAH) thicker than 10 mm with Glasgow Coma Scale (GCS)\< 13
    • 5. Patients with primarily interhemispheric or tentorial SDH
    • 6. Hypersensitivity to TXA or any of the placebo ingredients
    • 7. Pregnancy
    • 8. Irregular menstrual bleeding with unidentified cause
    • 9. Known acquired colour vision disturbances
    • 10. Hematuria caused by renal parenchymal disease
    • 11. Acute and chronic renal insufficiency indicated by estimated Glomerular Filtration Rate (eGFR) ≤ 30 mL/min
    • 12. 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)
    • 13. Consumption coagulopathy/disseminated intravascular coagulation (DIC) in the last 7 days
    • 14. Not competent to take study medication properly and regularly or not having access to caregiver that is able to comply with study medication administration
    • 15. Mechanical heart valve
    • 16. Contraindication to stopping full therapeutic doses of non-acetylsalicylic acid antiplatelets, warfarin, direct oral anticoagulant (e.g., apixaban) or other anticoagulant for 2 weeks after surgery or recent blood clot and/or recent thromboembolic complications in the last 2 weeks
    • 17. SDH caused by intracranial hypotension
    • 18. Known thrombophilia (e.g., antiphospholipid syndrome)
    • 19. Any active malignancy: metastatic cancer systemically or to the brain or a primary malignant brain tumour treated within the last 6 months
    • 20. Previous enrolment in this trial for a prior episode
    • 21. Time interval \>3 days from the time of clinical assessment to eligibility assessment
    • 22. Patients weighing \<45 kg or \>150 kg
The Use of Tranexamic Acid in the Treatment of Symptomatic Subdural Hematoma

Location Details

NCT05713630

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Locations

Not yet recruiting

Canada, Ontario

St. Michael's Hospital

Toronto, Ontario, Canada, M5B1T8