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

Study acronym: TRACE
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial status: Not Yet Recruiting to Recruiting Start date: Sep 30, 2025 to May 20, 2026 · Eligibility criteria expanded, about 13 words · Secondary endpoints: 16 to 17 · 1 morev16 Show 4 more changesShow less
    • Start date: Sep 30, 2025 to May 20, 2026
    • Eligibility criteria expanded, about 13 words
    • Secondary endpoints: 16 to 17
    • Site details revised

    See this version in full on ClinicalTrials.gov ↗

  2. Primary completion date: Mar 1, 2030 to Mar 30, 2027 Start date: Jun 1, 2025 to Sep 30, 2025 · Completion date: Nov 1, 2030 to Dec 31, 2030 · Eligibility criteria shortened, about 24 wordsv15 Show 3 more changesShow less
    • Start date: Jun 1, 2025 to Sep 30, 2025
    • Completion date: Nov 1, 2030 to Dec 31, 2030
    • Eligibility criteria shortened, about 24 words

    See this version in full on ClinicalTrials.gov ↗

  3. Start date: Mar 31, 2025 to Jun 1, 2025 Site contact updatedv14 Show 1 more changeShow less
    • Site contact updated
  4. Primary completion date: Mar 1, 2026 to Mar 1, 2030 Start date: Jan 31, 2025 to Mar 31, 2025 · Completion date: Nov 1, 2026 to Nov 1, 2030 · Site contact updated · 1 morev13 Show 4 more changesShow less
    • Start date: Jan 31, 2025 to Mar 31, 2025
    • Completion date: Nov 1, 2026 to Nov 1, 2030
    • Site contact updated
    • Collaborators: 3 to 2

    See this version in full on ClinicalTrials.gov ↗

  5. Start date: Aug 31, 2024 to Jan 31, 2025 Primary completion date: Mar 2026 to Mar 1, 2026 · Completion date: Nov 2026 to Nov 1, 2026v12 Show 2 more changesShow less
    • Primary completion date: Mar 2026 to Mar 1, 2026
    • Completion date: Nov 2026 to Nov 1, 2026
Show 10 earlier versionsHide 10 earlier versions
  1. Start date: Jul 2024 to Aug 31, 2024 Primary completion date: Dec 2025 to Mar 2026 · Completion date: Jul 2026 to Nov 2026 · Site contact updated · 1 morev11 Show 4 more changesShow less
    • Primary completion date: Dec 2025 to Mar 2026
    • Completion date: Jul 2026 to Nov 2026
    • Site contact updated
    • Collaborators revised (3)

    See this version in full on ClinicalTrials.gov ↗

  2. Re-verified, no change to tracked fieldsv10
  3. Primary completion date: Mar 2025 to Dec 2025 Start date: Mar 2024 to Jul 2024 · Completion date: Nov 2025 to Jul 2026 · Interventions: GD-Tranexamic Acid 500 MG Oral Tablet (Drug), Placebo (Drug), Sandoz-Tranexamic Acid 100 MG/ML (Drug), Sandoz-Tranexamic Acid 100 Mg/mL… to Placebo (Drug), Tranexamic acid (TXA) (Drug) · 1 morev9 Show 4 more changesShow less
    • Start date: Mar 2024 to Jul 2024
    • Completion date: Nov 2025 to Jul 2026
    • Interventions: GD-Tranexamic Acid 500 MG Oral Tablet (Drug), Placebo (Drug), Sandoz-Tranexamic Acid 100 MG/ML (Drug), Sandoz-Tranexamic Acid 100 Mg/mL… to Placebo (Drug), Tranexamic acid (TXA) (Drug)
    • Site contact updated
  4. Eligibility criteria revisedv8 See this version in full on ClinicalTrials.gov ↗
  5. Start date: Sep 2023 to Mar 2024v7
  6. Primary completion date: Nov 2026 to Mar 2025 Completion date: Mar 2027 to Nov 2025 · Publications: 76 to 68v6 Show 2 more changesShow less
    • Completion date: Mar 2027 to Nov 2025
    • Publications: 76 to 68

    See this version in full on ClinicalTrials.gov ↗

  7. Lead sponsor: Michael Cusimano to Unity Health Toronto Enrollment target: 514 to 130 · Eligibility criteria expanded, about 20 words · Publications: 72 to 76v5 Show 3 more changesShow less
    • Enrollment target: 514 to 130
    • Eligibility criteria expanded, about 20 words
    • Publications: 72 to 76

    See this version in full on ClinicalTrials.gov ↗

  8. Secondary endpoints: details revised at 1 of 16 entriesv4
  9. Interventions: Placebo (Drug), Tranexamic Acid 100 MG/ML (Drug), Tranexamic Acid 100 Mg/mL Solution for Injection (Drug), Tranexamic Acid 500 MG Oral… to GD-Tranexamic Acid 500 MG Oral Tablet (Drug), Placebo (Drug), Sandoz-Tranexamic Acid 100 MG/ML (Drug), Sandoz-Tranexamic Acid 100 Mg/mL…v3
  10. Study sites: 0 to 1v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05713630
Lead Sponsor Unity Health Toronto
Collaborators: Canadian Institutes of Health Research (CIHR), The Physicians' Services Incorporated Foundation
Conditions Subdural Hematoma
Enrollment 130 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov