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

PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

130

Participants

Timeline

Start Date

September 30, 2025

Primary Completion Date

March 30, 2027

Study Completion Date

December 31, 2030

Conditions
Subdural Hematoma
Interventions
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).

Trial Locations (1)

M5B1T8

St. Michael's Hospital, Toronto

All Listed Sponsors
collaborator

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

collaborator

The Physicians' Services Incorporated Foundation

OTHER

lead

Unity Health Toronto

OTHER