NCT05713630

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

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

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 130 (estimated)
• Sponsor: Unity Health Toronto · Academic / Other
• Sex: All
• Age: 45 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Subdural Hematoma

Interventions

Type	Name	Description
DRUG	Tranexamic acid (TXA)	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.
DRUG	Placebo	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).

Timeline

• Start date: 2025-09-30
• Primary completion: 2027-03-30
• Completion: 2030-12-31
• First posted: 2023-02-06
• Last updated: 2025-07-01

Locations

1 site across 1 country: Canada