Tranexamic Acid for Subdural Hematoma
(TRACE Trial)

Recruiting in Palo Alto (17 mi)

Overseen byMichael Cusimano, MD, MHPE, FRCS, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Michael Cusimano

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 5 Jurisdictions

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for individuals aged 45 and older, weighing between 45-150 kg, diagnosed with symptomatic subdural hematoma (SDH) of at least 8 mm thickness. Participants must have symptoms like headaches or confusion due to SDH but cannot be in a rapidly deteriorating state or have certain other brain injuries, severe kidney issues, known bleeding disorders, recent malignancies, or be pregnant.

Inclusion Criteria

I have SDH and experience symptoms like headaches, confusion, or seizures.

I am 45 or older, weigh between 45-150 kg, and have been diagnosed with symptomatic SDH.

I have a significant blood clot in my brain, shown on a CT scan.

Exclusion Criteria

Known acquired colour vision disturbances

SDH less than 8 mm in maximal thickness

Mechanical heart valve

+19 more

Participant Groups

The study tests Tranexamic Acid (TXA), which helps prevent blood clots from breaking down to reduce further bleeding in SDH patients. Some participants will receive TXA while others will get a placebo. The goal is to see if TXA can lower the chance of rebleeding post-surgery and improve recovery without additional surgeries.

2Treatment groups

Active Control

Placebo Group

Group I: Standard care + TXAActive Control1 Intervention

Patients will be given a single oral or IV loading dose of TXA within three hours of being randomized or whenever possible prior to surgery. Patients who are able to swallow will be given an oral loading dose of 1g TXA. Patients who are unable to swallow will be given an IV loading dose of 1g TXA which will be added to a 100mL infusion bag of NaCl 0.9% and infused by slow intravenous injection over 20 minutes as per the recommended rate of administration in the Product Monograph for Sandoz-Tranexamic Acid Injection BP. After 12 hours of the loading dose, patients will be given 500mg TXA by mouth (or 500mg TXA in NaCl 0.9% 100mL by IV for those unable to swallow) three times daily, totalling 1500mg/day, for 45 days.

Group II: Standard care + placeboPlacebo Group1 Intervention

Patients will be given a single oral or IV loading dose of placebo within three hours of being randomized or whenever possible prior to surgery. Patients who are able to swallow will be given an oral loading dose of 1g placebo (gelatin capsule composed of microcrystalline cellulose 105 powder NF). Patients who are unable to swallow will be given an IV loading dose of 1g placebo (sodium chloride also known as NaCl 0.9%) which will be added to a 100mL infusion bag of NaCl 0.9% and infused by slow intravenous injection over 20 minutes. After 12 hours of the loading dose, patients will be given 500mg placebo by mouth (or IV for those unable to swallow) three times a day, totalling 1500mg/day, for 45 days.

Tranexamic Acid is already approved in United States, European Union, Canada, Japan, Australia for the following indications:

🇺🇸 Approved in United States as Tranexamic Acid for: