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Antifibrinolytic Agent
Tranexamic Acid for Subdural Hematoma (TRACE Trial)
Phase 3
Waitlist Available
Led By Michael D Cusimano, MD, PhD
Research Sponsored by Michael Cusimano
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 45±10 days, 60-90 days, and 180±10 days after randomization
Awards & highlights
TRACE Trial Summary
This trial will test if a cheap drug, Tranexamic Acid (TXA), can help reduce bleeding and improve recovery in patients with Subdural Hematoma (SDH) after head injury.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Tranexamic Acid may cause side effects such as nausea, diarrhea, vomiting; it can also increase the risk of forming blood clots leading to deep vein thrombosis or stroke especially in people who are prone to clotting disorders.
TRACE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ discharge, 45±10 days, 60-90 days, and 180±10 days after randomization
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~discharge, 45±10 days, 60-90 days, and 180±10 days after randomization
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
European Quality of Life 5 Dimensions 5 Level Version (EQ-5D-5L)
Secondary outcome measures
Adverse events
Disability Rating Scale
Disposition after discharged from hospital
+13 moreTRACE Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: Standard care + TXAActive Control1 Intervention
Non-surgical patients will be given a single oral or IV loading dose of TXA within three hours of being randomized. For surgical patients, the same loading dose will be administered 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. After 12 hours of the loading dose, patients will be given 500 mg TXA by mouth (or IV for those unable to swallow) three times a day, totalling 1500 mg/day, for 45 days.
Group II: Standard care + placeboPlacebo Group1 Intervention
Non-surgical patients will be given a single oral or IV loading dose of placebo within three hours of being randomized. For surgical patients, the same loading dose will be administered 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%). After 12 hours of the loading dose, patients will be given 500 mg placebo by mouth (or IV for those unable to swallow) three times a day, totalling 1500 mg/day, for 45 days.
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Who is running the clinical trial?
Michael CusimanoLead Sponsor
Unity Health TorontoLead Sponsor
538 Previous Clinical Trials
447,593 Total Patients Enrolled
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,344 Previous Clinical Trials
26,453,287 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have SDH and experience symptoms like headaches, confusion, or seizures.I cannot stop taking certain blood thinners or have had recent blood clots.My condition is worsening quickly due to a severe brain bleed.I have a significant brain injury with a low consciousness level.My brain tumor is located between the brain's hemispheres or near the tentorium.I have not had symptoms for more than 72 hours.I experience unexplained irregular menstrual bleeding.I have blood in my urine due to kidney tissue disease.I have not been treated for any cancer that has spread or for brain cancer in the last 6 months.I haven't had blood clotting disorders like DIC in the past week.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.My headache is due to low brain pressure.I am currently taking birth control, hormone replacement therapy, or specific blood clotting medications.I cannot manage my medication by myself and do not have someone to help me.My kidney function is low, with an eGFR of 30 mL/min or less.I have a blood clotting disorder.I weigh less than 45 kg or more than 150 kg.
Research Study Groups:
This trial has the following groups:- Group 1: Standard care + TXA
- Group 2: Standard care + placebo
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How secure is the combination of conventional treatment and TXA for patients?
"There is prior clinical evidence that supports the safety of Standard care + TXA, thereby granting it a score of 3."
Answered by AI
Are there any open openings for participants in this experimentation?
"As per the info on clinicaltrials.gov, this particular investigation is not currently searching for participants. The study was initially marketed on September 1st 2023 and received its last update nine days later. Despite that, there are presently 58 other trials actively recruiting patients."
Answered by AI
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