Using tranexamic acid to help people with symptomatic subdural hematoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In this Phase 3 interventional study, participants with symptomatic subdural hematoma receive tranexamic acid or placebo to see if the drug lowers recurrent bleeding and supports faster recovery after initial management. Eligible adults are 45 years and older, weighing 45–150 kg, with a confirmed SDH of at least 8 mm on CT and related symptoms. The trial compares TXA to placebo and aims to determine safety and effectiveness as a non-surgical or adjunctive therapy. Outcomes focus on bleeding recurrence, time to clinical improvement, and functional status.

Why it matters

Who can join: the full rules

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. Liver cirrhosis
17. Recent venous and/or arterial thromboembolism within 6 months of study enrolment
18. SDH caused by intracranial hypotension
19. Known thrombophilia (e.g., antiphospholipid syndrome)
20. Any active malignancy: metastatic cancer systemically or to the brain or a primary malignant brain tumour treated within the last 6 months
21. Previous enrolment in this trial for a prior episode
22. Time interval \>3 days from the time of clinical assessment to eligibility assessment
23. Patients weighing \<45 kg or \>150 kg
24. Patients received any amount of TXA upon admittance to hospital prior to enrolment

Where it's running

• St. Michael's Hospital
  Toronto, Ontario, Canada Recruiting

Study contacts

• Principal investigator: Michael D Cusimano, MD, PhD — Unity Health Toronto
• Study coordinator: Michael D Cusimano, MD, PhD
• Email: injuryprevention@smh.ca
• Phone: 416-864-5312

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Non-Thermal Plasma Used During Surgery to Help Prevent Recurrent Chronic Subdural Hematoma

  A randomized trial tests whether applying non-thermal plasma during standard surgery to drain a chronic subdural hematoma can reduce recurrence within 6 months.

  Recruiting National Institute of Nuclear Research - Mexico · Ocoyoacac, State of Mexico · NCT07656818

• MMA Embolization with NeoCast for Subacute and Chronic Subdural Hematoma

  This trial tests whether the NeoCast Embolic System safely and effectively works to treat subacute or chronic subdural hematomas after surgery, compared with the Onyx liquid embolic.

  Recruiting Arsenal Medical, Inc. · New Haven, Connecticut and 1 other locations · NCT07541404

• Histoacryl glue embolization of the middle meningeal artery for chronic subdural hematoma (HARMONY)

  This study tests whether injecting Histoacryl glue into the middle meningeal artery can prevent recurrence or worsening of chronic subdural hematoma in adults.

  Recruiting at 3 sites Aesculap AG · Fukuoka, Kitakyushu-city and 5 other locations · NCT07258069

• Scalp block versus general anesthesia for burr‑hole evacuation of subdural hematoma

  This trial tests whether using a scalp block instead of general anesthesia helps adults (18–75) having burr‑hole evacuation of a subdural hematoma.

  Recruiting Sohag University · Sohag · NCT07143799

• Evaluating outcomes in neurosurgery using standardized measures

  This study is trying to see how different factors affect the results of brain surgeries by collecting information from patients before and after their operations.

  Recruiting at 11 sites Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta · Bergamo, BG and 26 other locations · NCT06724029

• Evaluating a new method for draining fluid and blood in brain hemorrhages

  This study is testing a new device for draining fluid and blood from the brain to see if it works better than the standard method for patients with brain hemorrhages.

  Recruiting Ohio State University · Columbus, Ohio · NCT05649904

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.