Subdural HematomaPhase 3TRACENCT05713630
The Use of Tranexamic Acid in the Treatment of Symptomatic Subdural Hematoma
A Phase 3 study testing Tranexamic acid (TXA) in people with Subdural Hematoma, run by Unity Health Toronto at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Subdural Hematoma
- What is being tested?
- Tranexamic acid (TXA)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 130 participants
- Where
- 1 siteCanada
- Study dates
- 20 May 2026to 31 Dec 2030
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 45 and older weighing between 45-150 kg diagnosed with symptomatic SDH will be included. SDH is defined as unilateral or bilateral crescentic collection of blood (hyper, iso, or hypodense, or mixed density) of greater than or equals to 8 mm in thickness along the cerebral convexity on CT of the head. Symptomatic SDH patients eligible for inclusion are those with SDH with one or more of the following symptoms attributable to the SDH: headache, gait disturbance, confusion or cognitive decline, limb weakness or numbness/paresthesia, speech or visual disturbance, drowsiness or impaired consciousness, seizures, impaired cognition, or memory loss at the time of assessment.
Who cannot join
- Patients will be excluded for any of the following conditions:
- Asymptomatic for longer than 72 hours
- SDH less than 8 mm in maximal thickness
- Have an acutely deteriorating neurological status (e.g., brain herniation with pupillary dilation, aneurysm rupture, etc.) that is likely to be fatal within 6 hours or less due to a predominantly acute SDH
- Presence of brain contusion larger than 5 cubic centimeters or subarachnoid hemorrhage (SAH) thicker than 10 mm with Glasgow Coma Scale (GCS)< 13
- Patients with primarily interhemispheric or tentorial SDH
Show all 25Show fewer
- Hypersensitivity to TXA or any of the placebo ingredients
- Pregnancy
- Irregular menstrual bleeding with unidentified cause
- Known acquired colour vision disturbances
- Hematuria caused by renal parenchymal disease
- Acute and chronic renal insufficiency indicated by estimated Glomerular Filtration Rate (eGFR) ≤ 30 mL/min
- Concomitant intake of birth control pill and/or hormonal replacement therapy, and anti-inhibitor coagulant concentrates (factor VIII inhibitor bypass activity (FEIBA), factor VII, activated factor IX)
- Consumption coagulopathy/disseminated intravascular coagulation (DIC) in the last 7 days
- Not competent to take study medication properly and regularly or not having access to caregiver that is able to comply with study medication administration
- Mechanical heart valve
- Liver cirrhosis
- Recent venous and/or arterial thromboembolism within 6 months of study enrolment
- SDH caused by intracranial hypotension
- Known thrombophilia (e.g., antiphospholipid syndrome)
- Any active malignancy: metastatic cancer systemically or to the brain or a primary malignant brain tumour treated within the last 6 months
- Previous enrolment in this trial for a prior episode
- Time interval >3 days from the time of clinical assessment to eligibility assessment
- Patients weighing <45 kg or >150 kg
- Patients received any amount of TXA upon admittance to hospital prior to enrolment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
St. Michael's Hospital
Toronto, Ontario, M5B1T8
Melissa C Fazari, M.Sc, 437-655-1471, injuryprevention@smh.ca
Stanley Zhang, B.M., 416-864-5312, shudong.zhang@unityhealth.to
About this study
Official title: TRACE STUDY: A Randomized Controlled Trial Using Tranexamic Acid in the Treatment of Subdural Hematoma
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
- Being tested
- Tranexamic acid (TXA), Placebo
- Keywords
- symptomatic subdural hematoma, tranexamic acid, TXA, clinical trial, neurosurgery
- Medical subject headings
- Hematoma, Subdural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic acid (TXA)Drug
Also called Cyklokapron
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.
PlaceboDrug
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).
| Study group | Role | What they receive |
|---|---|---|
| Standard care + TXA | Active comparator | 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. Receives: Drug: Tranexamic acid (TXA) |
| Standard care + placebo | Placebo comparator | 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
European Quality of Life 5 Dimensions 5 Level Version (EQ-5D-5L)
A self-rated questionnaire that assesses a patient's health state in five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
Measured: Every 2 weeks after randomization up to 45±10 days.
Secondary outcomes (17)
Patient-Reported Outcomes Measurement Information System (PROMIS) Scale v1.2 - Global Health. English and French versions
A 10-item measure that assesses an individual's general physical, mental, and social health as it is intended to globally reflect individuals' assessment of their physical and mental health in the last 7 days.
Measured: Baseline and every 2 weeks after randomization up to 45±10 days, and then at 60-90 days, and 180±10 days after randomization.
PROMIS Item Bank v2.0 - Cognitive Function. English version
A measure that assesses cognitive function that will be administered as a computer adaptive test.
Measured: Baseline and every 2 weeks after randomization up to 45±10 days, and then at 60-90 days, and 180±10 days after randomization.
PROMIS Item Bank v2.0 - Physical Function. English version
A measure that assesses self-reported capability rather than actual performance of physical activities that will be administered as a computer adaptive test.
Measured: Baseline and every 2 weeks after randomization up to 45±10 days, and then at 60-90 days, and 180±10 days after randomization.
PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities. English version
A measure that assesses the perceived ability to perform one's usual social roles and activities that will be administered as a computer adaptive test. The item bank does not use a time frame (e.g. over the past 7 days) when assessing ability to participate in social roles and activities.
Measured: Baseline and every 2 weeks after randomization up to 45±10 days, and then at 60-90 days, and 180±10 days after randomization.
Subdural hematoma volume change
Change in hematoma volume in millilitres on CT scan.
Measured: Baseline, 45±10 days after randomization, and 60-90 days if deemed necessary for the patient's routine care.
Number of subdural hematoma-related surgical interventions
Measured: First admission, subsequent admissions up to 180 days after randomization
Recurrence rate of SDH
Measured: 45±10 days, 60-90 days, and 180±10 days after randomization
Mortality
Measured: During the course of study up to 180±10 days after randomization
Modified Rankin Scale
A 6-point disability scale used to measure the degree of disability in patients who have had a stroke.
Measured: Baseline, 45±10 days, 60-90 days, and 180±10 days after randomization
Disability Rating Scale
Eight questions regarding body function, activity, participation, communication, and movements each rated on a 3-5-point scale that is summed to give a total score.
Measured: Baseline, 45±10 days, 60-90 days, and 180±10 days after randomization
Montreal Cognitive Assessment
This assessment evaluates the patient's cognition based on eight areas: visuospatial/executive function, naming, memory, attention, language, abstraction, delayed recall, and orientation.
Measured: Baseline, 45±10 days, and 60-90 days after randomization
Medical Consumption Questionnaire
Health-related cost questionnaire on the use of healthcare in the past month.
Measured: Baseline, 45±10 days, and 180±10 days after randomization
EQ-5D-5L
A self-rated questionnaire that assesses a patient's health state in five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
Measured: Baseline, 60-90 days, and 180±10 days after randomization
Adverse events
Adverse events of grade 3 or higher as defined by Good Clinical Practice Guidelines.
Measured: Discharge, 45±10 days, 60-90 days, and 180±10 days after randomization
Length of stay in hospital due to subdural hematoma
Measured: During the course of the study up to 180±10 days after randomization
Disposition after discharged from hospital
Measured: During the course of the study up to 180±10 days after randomization
Groningen Frailty Indicator
A 15-item questionnaire assessing mobility, vision, hearing, nutrition, comorbidity, cognition, psychosocial and physical well-being. Each item is scored dichotomously, with a value of 1 assigned when a deficit is present.
Measured: Baseline and 45±10 days after randomization.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2023
- Study start20 May 2026 (estimated)
- Primary completion30 Mar 2027 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (68)Papers the sponsor has linked to this study.
- Other trials for Subdural HematomaStudies of the same condition, open and under way.
- More trials run by Unity Health TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Vanguard trial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), The Physicians' Services Incorporated Foundation
- Responsible party
- Sponsor
- Investigators
- Michael D Cusimano, MD, PhD, Principal investigator, Unity Health Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05713630
- Sponsor's protocol ID
- 471164
- Acronym
- TRACE
- Status last verified
- May 2026
- First submitted
- 26 Jan 2023
- Last updated
- 29 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fu TS, Jing R, McFaull SR, Cusimano MD. Recent trends in hospitalization and in-hospital mortality associated with traumatic brain injury in Canada: A nationwide, population-based study. J Trauma Acute Care Surg. 2015 Sep;79(3):449-54. doi: 10.1097/ta.0000000000000733.
PubMed 26535433Jiang R, Zhao S, Wang R, Feng H, Zhang J, Li X, Mao Y, Yuan X, Fei Z, Zhao Y, Yu X, Poon WS, Zhu X, Liu N, Kang D, Sun T, Jiao B, Liu X, Yu R, Zhang J, Gao G, Hao J, Su N, Yin G, Zhu X, Lu Y, Wei J, Hu J, Hu R, Li J, Wang D, Wei H, Tian Y, Lei P, Dong JF, Zhang J. Safety and Efficacy of Atorvastatin for Chronic Subdural Hematoma in Chinese Patients: A Randomized ClinicalTrial. JAMA Neurol. 2018 Nov 1;75(11):1338-1346. doi: 10.1001/jamaneurol.2018.2030.
PubMed 30073290Kudo H, Kuwamura K, Izawa I, Sawa H, Tamaki N. Chronic subdural hematoma in elderly people: present status on Awaji Island and epidemiological prospect. Neurol Med Chir (Tokyo). 1992 Apr;32(4):207-9. doi: 10.2176/nmc.32.207.
PubMed 1378564Balser D, Farooq S, Mehmood T, Reyes M, Samadani U. Actual and projected incidence rates for chronic subdural hematomas in United States Veterans Administration and civilian populations. J Neurosurg. 2015 Nov;123(5):1209-15. doi: 10.3171/2014.9.JNS141550. Epub 2015 Mar 20.
PubMed 25794342Brennan PM, Kolias AG, Joannides AJ, Shapey J, Marcus HJ, Gregson BA, Grover PJ, Hutchinson PJ, Coulter IC; British Neurosurgical Trainee Research Collaborative. The management and outcome for patients with chronic subdural hematoma: a prospective, multicenter, observational cohort study in the United Kingdom. J Neurosurg. 2017 Mar 17:1-8. doi: 10.3171/2016.8.JNS16134.test. Online ahead of print.
PubMed 28306417Rauhala M, Helen P, Huhtala H, Heikkila P, Iverson GL, Niskakangas T, Ohman J, Luoto TM. Chronic subdural hematoma-incidence, complications, and financial impact. Acta Neurochir (Wien). 2020 Sep;162(9):2033-2043. doi: 10.1007/s00701-020-04398-3. Epub 2020 Jun 10.
PubMed 32524244Balser D, Rodgers SD, Johnson B, Shi C, Tabak E, Samadani U. Evolving management of symptomatic chronic subdural hematoma: experience of a single institution and review of the literature. Neurol Res. 2013 Apr;35(3):233-42. doi: 10.1179/1743132813Y.0000000166.
PubMed 23485050Lee KS. Natural history of chronic subdural haematoma. Brain Inj. 2004 Apr;18(4):351-8. doi: 10.1080/02699050310001645801.
PubMed 14742149Sahyouni R, Goshtasbi K, Mahmoodi A, Tran DK, Chen JW. Chronic Subdural Hematoma: A Historical and Clinical Perspective. World Neurosurg. 2017 Dec;108:948-953. doi: 10.1016/j.wneu.2017.09.064. Epub 2017 Sep 19.
PubMed 28935548Cofano F, Pesce A, Vercelli G, Mammi M, Massara A, Minardi M, Palmieri M, D'Andrea G, Fronda C, Lanotte MM, Tartara F, Zenga F, Frati A, Garbossa D. Risk of Recurrence of Chronic Subdural Hematomas After Surgery: A Multicenter Observational Cohort Study. Front Neurol. 2020 Nov 24;11:560269. doi: 10.3389/fneur.2020.560269. eCollection 2020.
PubMed 33329304Hammer A, Tregubow A, Kerry G, Schrey M, Hammer C, Steiner HH. Predictors for Recurrence of Chronic Subdural Hematoma. Turk Neurosurg. 2017;27(5):756-762. doi: 10.5137/1019-5149.JTN.17347-16.1.
PubMed 27593834Miranda LB, Braxton E, Hobbs J, Quigley MR. Chronic subdural hematoma in the elderly: not a benign disease. J Neurosurg. 2011 Jan;114(1):72-6. doi: 10.3171/2010.8.JNS10298. Epub 2010 Sep 24.
PubMed 20868215Weigel R, Schmiedek P, Krauss JK. Outcome of contemporary surgery for chronic subdural haematoma: evidence based review. J Neurol Neurosurg Psychiatry. 2003 Jul;74(7):937-43. doi: 10.1136/jnnp.74.7.937.
PubMed 12810784Liu W, Bakker NA, Groen RJ. Chronic subdural hematoma: a systematic review and meta-analysis of surgical procedures. J Neurosurg. 2014 Sep;121(3):665-73. doi: 10.3171/2014.5.JNS132715. Epub 2014 Jul 4.
PubMed 24995782Peng Z, Ban K, LeBlanc A, Kozar RA. Intraluminal tranexamic acid inhibits intestinal sheddases and mitigates gut and lung injury and inflammation in a rodent model of hemorrhagic shock. J Trauma Acute Care Surg. 2016 Aug;81(2):358-65. doi: 10.1097/TA.0000000000001056.
PubMed 27027557
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TRACE STUDY: A Randomized Controlled Trial Using Tranexamic Acid in the Treatment of Subdural Hematoma
- ClinicalTrials.gov ID
- NCT05713630
- Acronym / sponsor ID
- TRACE / 471164
- Conditions
- Subdural Hematoma
- Keywords
- symptomatic subdural hematoma, tranexamic acid, TXA, clinical trial, neurosurgery
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), The Physicians' Services Incorporated Foundation
- Study start
- 20 May 2026 (estimated)
- Primary completion
- 30 Mar 2027 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 6 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Vanguard trial
| Arm | Type | Receives |
|---|---|---|
| Standard care + TXA | Active comparator | Drug: Tranexamic acid (TXA)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. |
| Standard care + placebo | Placebo comparator | Drug: PlaceboPatients 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. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients aged 45 and older weighing between 45-150 kg diagnosed with symptomatic SDH will be included. SDH is defined as unilateral or bilateral crescentic collection of blood (hyper, iso, or hypodense, or mixed density) of greater than or equals to 8 mm in thickness along the cerebral convexity on CT of the head. Symptomatic SDH patients eligible for inclusion are those with SDH with one or more of the following symptoms attributable to the SDH: headache, gait disturbance, confusion or cognitive decline, limb weakness or numbness/paresthesia, speech or visual disturbance, drowsiness or impaired consciousness, seizures, impaired cognition, or memory loss at the time of assessment.
Key exclusion criteria (25 listed)
- Patients will be excluded for any of the following conditions:
- Asymptomatic for longer than 72 hours
- SDH less than 8 mm in maximal thickness
- Have an acutely deteriorating neurological status (e.g., brain herniation with pupillary dilation, aneurysm rupture, etc.) that is likely to be fatal within 6 hours or less due to a predominantly acute SDH
- Presence of brain contusion larger than 5 cubic centimeters or subarachnoid hemorrhage (SAH) thicker than 10 mm with Glasgow Coma Scale (GCS)< 13
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tranexamic acid (TXA)Also: CyklokapronMarcan-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 | Standard care + TXA |
| PlaceboPlacebo 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). | Drug | Standard care + placebo |
Primary outcome
European Quality of Life 5 Dimensions 5 Level Version (EQ-5D-5L)
Time frame: Every 2 weeks after randomization up to 45±10 days.
A self-rated questionnaire that assesses a patient's health state in five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
17 secondary outcomes
Patient-Reported Outcomes Measurement Information System (PROMIS) Scale v1.2 - Global Health. English and French versions
Time frame: Baseline and every 2 weeks after randomization up to 45±10 days, and then at 60-90 days, and 180±10 days after randomization.
PROMIS Item Bank v2.0 - Cognitive Function. English version
Time frame: Baseline and every 2 weeks after randomization up to 45±10 days, and then at 60-90 days, and 180±10 days after randomization.
PROMIS Item Bank v2.0 - Physical Function. English version
Time frame: Baseline and every 2 weeks after randomization up to 45±10 days, and then at 60-90 days, and 180±10 days after randomization.
PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities. English version
Time frame: Baseline and every 2 weeks after randomization up to 45±10 days, and then at 60-90 days, and 180±10 days after randomization.
Subdural hematoma volume change
Time frame: Baseline, 45±10 days after randomization, and 60-90 days if deemed necessary for the patient's routine care.
Number of subdural hematoma-related surgical interventions
Time frame: First admission, subsequent admissions up to 180 days after randomization
Recurrence rate of SDH
Time frame: 45±10 days, 60-90 days, and 180±10 days after randomization
Mortality
Time frame: During the course of study up to 180±10 days after randomization
Modified Rankin Scale
Time frame: Baseline, 45±10 days, 60-90 days, and 180±10 days after randomization
Disability Rating Scale
Time frame: Baseline, 45±10 days, 60-90 days, and 180±10 days after randomization
Montreal Cognitive Assessment
Time frame: Baseline, 45±10 days, and 60-90 days after randomization
Medical Consumption Questionnaire
Time frame: Baseline, 45±10 days, and 180±10 days after randomization
EQ-5D-5L
Time frame: Baseline, 60-90 days, and 180±10 days after randomization
Adverse events
Time frame: Discharge, 45±10 days, 60-90 days, and 180±10 days after randomization
Length of stay in hospital due to subdural hematoma
Time frame: During the course of the study up to 180±10 days after randomization
Disposition after discharged from hospital
Time frame: During the course of the study up to 180±10 days after randomization
Groningen Frailty Indicator
Time frame: Baseline and 45±10 days after randomization.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
- Background: PubMed 26535433Fu TS, Jing R, McFaull SR, Cusimano MD. Recent trends in hospitalization and in-hospital mortality associated with traumatic brain injury in Canada: A nationwide, population-based study. J Trauma Acute Care Surg. 2015 Sep;79(3):449-54. doi: 10.1097/ta.0000000000000733.
- Background: PubMed 30073290Jiang R, Zhao S, Wang R, Feng H, Zhang J, Li X, Mao Y, Yuan X, Fei Z, Zhao Y, Yu X, Poon WS, Zhu X, Liu N, Kang D, Sun T, Jiao B, Liu X, Yu R, Zhang J, Gao G, Hao J, Su N, Yin G, Zhu X, Lu Y, Wei J, Hu J, Hu R, Li J, Wang D, Wei H, Tian Y, Lei P, Dong JF, Zhang J. Safety and Efficacy of Atorvastatin for Chronic Subdural Hematoma in Chinese Patients: A Randomized ClinicalTrial. JAMA Neurol. 2018 Nov 1;75(11):1338-1346. doi: 10.1001/jamaneurol.2018.2030.
- Background: PubMed 1378564Kudo H, Kuwamura K, Izawa I, Sawa H, Tamaki N. Chronic subdural hematoma in elderly people: present status on Awaji Island and epidemiological prospect. Neurol Med Chir (Tokyo). 1992 Apr;32(4):207-9. doi: 10.2176/nmc.32.207.
- Background: PubMed 25794342Balser D, Farooq S, Mehmood T, Reyes M, Samadani U. Actual and projected incidence rates for chronic subdural hematomas in United States Veterans Administration and civilian populations. J Neurosurg. 2015 Nov;123(5):1209-15. doi: 10.3171/2014.9.JNS141550. Epub 2015 Mar 20.
- Background: PubMed 28306417Brennan PM, Kolias AG, Joannides AJ, Shapey J, Marcus HJ, Gregson BA, Grover PJ, Hutchinson PJ, Coulter IC; British Neurosurgical Trainee Research Collaborative. The management and outcome for patients with chronic subdural hematoma: a prospective, multicenter, observational cohort study in the United Kingdom. J Neurosurg. 2017 Mar 17:1-8. doi: 10.3171/2016.8.JNS16134.test. Online ahead of print.
- Background: PubMed 32524244Rauhala M, Helen P, Huhtala H, Heikkila P, Iverson GL, Niskakangas T, Ohman J, Luoto TM. Chronic subdural hematoma-incidence, complications, and financial impact. Acta Neurochir (Wien). 2020 Sep;162(9):2033-2043. doi: 10.1007/s00701-020-04398-3. Epub 2020 Jun 10.
- Background: PubMed 23485050Balser D, Rodgers SD, Johnson B, Shi C, Tabak E, Samadani U. Evolving management of symptomatic chronic subdural hematoma: experience of a single institution and review of the literature. Neurol Res. 2013 Apr;35(3):233-42. doi: 10.1179/1743132813Y.0000000166.
- Background: PubMed 14742149Lee KS. Natural history of chronic subdural haematoma. Brain Inj. 2004 Apr;18(4):351-8. doi: 10.1080/02699050310001645801.
- Background: PubMed 28935548Sahyouni R, Goshtasbi K, Mahmoodi A, Tran DK, Chen JW. Chronic Subdural Hematoma: A Historical and Clinical Perspective. World Neurosurg. 2017 Dec;108:948-953. doi: 10.1016/j.wneu.2017.09.064. Epub 2017 Sep 19.
- Background: PubMed 33329304Cofano F, Pesce A, Vercelli G, Mammi M, Massara A, Minardi M, Palmieri M, D'Andrea G, Fronda C, Lanotte MM, Tartara F, Zenga F, Frati A, Garbossa D. Risk of Recurrence of Chronic Subdural Hematomas After Surgery: A Multicenter Observational Cohort Study. Front Neurol. 2020 Nov 24;11:560269. doi: 10.3389/fneur.2020.560269. eCollection 2020.
- Background: PubMed 27593834Hammer A, Tregubow A, Kerry G, Schrey M, Hammer C, Steiner HH. Predictors for Recurrence of Chronic Subdural Hematoma. Turk Neurosurg. 2017;27(5):756-762. doi: 10.5137/1019-5149.JTN.17347-16.1.
- Background: PubMed 20868215Miranda LB, Braxton E, Hobbs J, Quigley MR. Chronic subdural hematoma in the elderly: not a benign disease. J Neurosurg. 2011 Jan;114(1):72-6. doi: 10.3171/2010.8.JNS10298. Epub 2010 Sep 24.
- Product Monograph for Marcan-Tranexamic Acid TabletsLink provided by the sponsor.
- Product Monograph for Sandoz-Tranexamic Acid Injection BPLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michael D Cusimano, MD, PhD principal investigator
Unity Health Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tranexamic acid (TXA) in people with Subdural Hematoma, run by Unity Health Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michael D Cusimano, MD, PhD (416-864-5312, injuryprevention@smh.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
European Quality of Life 5 Dimensions 5 Level Version (EQ-5D-5L) (time frame: Every 2 weeks after randomization up to 45±10 days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05713630, which also lists 68 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2026.