Chronic Subdural HematomaPhase 2TRACE-2NCT04898712
Tranexamic Acid in the Treatment of Residual Chronic Subdural Hematoma -2
A Phase 2 study testing Tranexamic Acid 500 MG in people with Chronic Subdural Hematoma, run by Unity Health Toronto at 1 site in Canada.
Trial summary
Chronic subdural hematoma (CSDH), a common disease after minor head trauma, is characterized by blood collection in the subdural space, which can result in severe neurological impairment. The current standard of care is the surgical evacuation of CSDH. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Subdural Hematoma
- What is being tested?
- Tranexamic Acid 500 MG
- 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
- 90 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2021to Dec 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of chronic subdural hematoma (CSDH)
- Written informed consent (patient, power of attorney or substitute decision maker)
- Competence to take study medication properly and regularly or access to caregiver that is able to comply with accurate study medication administration
Who cannot join
- Hypersensitivity to TXA or any of the ingredients
- Pregnancy
- Irregular menstrual bleeding with unidentified cause
- Acquired colour vision disturbances
- Acute and chronic renal insufficiency indicated by GFR ≤ 30 mL/min
- Hematuria, caused by diseases of renal parenchyma
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- Concomitant intake of hormonal contraceptives, factor IX complex concentrates, and anti-inhibitor coagulant concentrates (factor VII, activated factor IX)
- History of angioplasty with cardiac stent placement, or cardiac (including mechanical) valve placement
- Active history of stroke (hemorrhagic and ischemic), or subarachnoid hemorrhage, within the past 6 months
- Consumption coagulopathy/disseminated intravascular coagulation (DIC) in the last 7 days
- History of malignant brain tumors (glioma, metastasis and others) or seizures within the 6 months
- Contraindication to stopping full therapeutic doses of non-ASA antiplatelets, warfarin, rivaroxaban, apixaban, dabigatran, or other anticoagulant for 2 weeks after surgery
- Inability of oral drug intake or missing support to guarantee oral drug intake
- SDH as caused by intracranial hypotension resulting from CSF shunt placement
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Tranexamic Acid in the Treatment of Residual Chronic Subdural Hematoma: An Observer-blinded, Randomized Controlled Trial
Chronic subdural hematoma (CSDH), a common disease after minor head trauma, is characterized by blood collection in the subdural space, which can result in severe neurological impairment. The current standard of care is the surgical evacuation of CSDH. Although clinical and surgical outcomes are satisfying in most cases, considerable morbidity, mortality and recurrence rates of 3-31% are frequently reported. Therefore a non-surgical approach to treat CSDH is desirable. Tranexamic acid (TXA), an antifibrinolytic drug, has been shown to decrease hematoma volume in a small cohort of CSDH patients. The present study is designed to test the hypothesis that TXA can reduce the volume of CSDH. Volume measurements of residual CSDH after burr-hole surgery will be performed to quantify treatment success. The trial is designed as a double-blinded randomized controlled trial, where half of the patients will be assigned to daily intake of TXA, whereas the other half will receive placebo. The primary endpoint is defined as volume change in milliliter after 4-8 weeks of treatment. Secondary endpoints are hematoma volume at 8-12 weeks, patient safety, the number of patients with resolution of the CSDH after 4-8 and 8-12 weeks of study participation, the neurological outcome, the rate of reoperation, the time to reoperation, drug safety and compatibility, and participant quality of life (QOL).
- Conditions
- Chronic Subdural Hematoma
- Being tested
- Tranexamic Acid 500 MG, Placebo
- Keywords
- Tranexamic acid, Chronic Subdural Hematoma, Neurosurgery
- Medical subject headings
- Hematoma, Subdural, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic Acid 500 MGDrug
Tranexamic Acid 500mg oral tablets
PlaceboDrug
The placebo will consist of an identical capsule to over-encapsulated tranexamic acid oral tablet entirely filled with microcrystalline cellulose, and sealed.
| Study group | Role | What they receive |
|---|---|---|
| Tranexamic Acid Arm | Experimental | Participants in the experimental arm will receive tranexamic acid (TXA) during surgery for CSDH evacuation with a single 1000mg intraoperative intravenous (IV) dose. Participants with a body weight 60-100kg will also receive a post-operative dose regimen of 500 mg TXA orally, 3 times a day (TID).
Weight deviations from this body weight range will be considered with a dose adjustment of 1000mg TXA two times a day (BID) for a body weight >100 kg, and 500 mg TXA BID for body weight <60kg. Receives: Drug: Tranexamic Acid 500 MG |
| Placebo Control Arm | Placebo comparator | Participants in the control arm will placebo according to the same administration regimen. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chronic subdural hematoma volume change
Change in hematoma volume in mL according to CT-scan-based volume measurements comparing hematoma on CT scan performed at 4-8 weeks to hematoma on immediate post-operative CT scan.
Measured: At 4-8 weeks
Secondary outcomes (8)
Chronic subdural hematoma volume change
Change in hematoma volume in mL according to CT-scan-based volume measurements comparing hematoma on CT scan performed at 4-8 weeks to hematoma on immediate post-operative CT scan.
Measured: At 12 weeks
Rate of adverse events (AEs)
Adverse events investigated include:
- suspected stroke
- myocardial infarction
- deep vein thrombosis
- thromboembolic events
- decline in renal function
- new-onset neurological deterioration
Serious adverse events include:
- evidence of stroke
- myocardial infarction
- deep vein thrombosis
- thromboembolic events
- convulsions
- severe allergic reactions
- evidence of retinal degeneration
- necessity of hospital admission
- mortality
Measured: At 4, 8, and 12 weeks
36-Item Short Form Survey (SF-36)
Questionnaire assessing patient quality of life outcome profile
Measured: At 4, 8, 12 weeks
National Institutes of Health Stroke Scale (NIHSS)
Change in National Institutes of Health Stroke Scale (NIHSS) score (neurological outcome) at 4-8 weeks and 8-12 weeks, compared to the baseline visit score
Minimum scale score: 0; Maximum scale score: 42. Higher score means worse neurological impairment.
Measured: At 4, 8, and 12 weeks
Modified Rankin Scale (mRS)
Change in Modified Rankin Scale (mRS) score (neurological outcome) at 4-8 weeks and 8-12 weeks, compared to the baseline visit score
Minimum scale score: 0 (no symptoms); Maximum scale score: 6 (death). Higher score means worse neurological outcome.
Measured: At 4, 8, and 12 weeks
Markwalder's grading scale (MGS)
Change in Markwalder's grading scale (MGS) score (neurological outcome) at 4-8 weeks and 8-12 weeks, compared to the baseline visit score
Minimum scale score: 0 (normal); Maximum scale score: 4. Higher score means worse neurological outcome.
Measured: At 4, 8, and 12 weeks
Rate of re-operation
Rate of re-operation during study course due to hematoma enlargement or other significant cause
Measured: At 4, 8, and 12 weeks
Time to reoperation
Time to reoperation during study course due to hematoma enlargement or other significant cause
Measured: At 4, 8, and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2021
- Study startJul 2021 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- The Physicians' Services Incorporated Foundation
- Responsible party
- Sponsor
- Investigators
- Michael D Cusimano, MD, PhD, Principal investigator, St. Michael's Hospital / University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04898712
- Sponsor's protocol ID
- 17-232
- Acronym
- TRACE-2
- Status last verified
- May 2021
- First submitted
- 12 May 2021
- Last updated
- 24 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tranexamic Acid in the Treatment of Residual Chronic Subdural Hematoma: An Observer-blinded, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04898712
- Acronym / sponsor ID
- TRACE-2 / 17-232
- Conditions
- Chronic Subdural Hematoma
- Keywords
- Tranexamic acid, Chronic Subdural Hematoma, Neurosurgery
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Collaborators
- The Physicians' Services Incorporated Foundation
- Study start
- Jul 2021 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 24 May 2021 (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.
Chronic subdural hematoma (CSDH), a common disease after minor head trauma, is characterized by blood collection in the subdural space, which can result in severe neurological impairment. The current standard of care is the surgical evacuation of CSDH. Although clinical and surgical outcomes are satisfying in most cases, considerable morbidity, mortality and recurrence rates of 3-31% are frequently reported. Therefore a non-surgical approach to treat CSDH is desirable. Tranexamic acid (TXA), an antifibrinolytic drug, has been shown to decrease hematoma volume in a small cohort of CSDH patients. The present study is designed to test the hypothesis that TXA can reduce the volume of CSDH. Volume measurements of residual CSDH after burr-hole surgery will be performed to quantify treatment success. The trial is designed as a double-blinded randomized controlled trial, where half of the patients will be assigned to daily intake of TXA, whereas the other half will receive placebo. The primary endpoint is defined as volume change in milliliter after 4-8 weeks of treatment. Secondary endpoints are hematoma volume at 8-12 weeks, patient safety, the number of patients with resolution of the CSDH after 4-8 and 8-12 weeks of study participation, the neurological outcome, the rate of reoperation, the time to reoperation, drug safety and compatibility, and participant quality of life (QOL).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tranexamic Acid Arm | Experimental | Drug: Tranexamic Acid 500 MGParticipants in the experimental arm will receive tranexamic acid (TXA) during surgery for CSDH evacuation with a single 1000mg intraoperative intravenous (IV) dose. Participants with a body weight 60-100kg will also receive a post-operative dose regimen of 500 mg TXA orally, 3 times a day (TID). Weight deviations from this body weight range will be considered with a dose adjustment of 1000mg TXA two times a day (BID) for a body weight >100 kg, and 500 mg TXA BID for body weight <60kg. |
| Placebo Control Arm | Placebo comparator | Drug: PlaceboParticipants in the control arm will placebo according to the same administration regimen. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of chronic subdural hematoma (CSDH)
- Written informed consent (patient, power of attorney or substitute decision maker)
- Competence to take study medication properly and regularly or access to caregiver that is able to comply with accurate study medication administration
Key exclusion criteria (14 listed)
- Hypersensitivity to TXA or any of the ingredients
- Pregnancy
- Irregular menstrual bleeding with unidentified cause
- Acquired colour vision disturbances
- Acute and chronic renal insufficiency indicated by GFR ≤ 30 mL/min
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 500 MGTranexamic Acid 500mg oral tablets | Drug | Tranexamic Acid Arm |
| PlaceboThe placebo will consist of an identical capsule to over-encapsulated tranexamic acid oral tablet entirely filled with microcrystalline cellulose, and sealed. | Drug | Placebo Control Arm |
Primary outcome
Chronic subdural hematoma volume change
Time frame: At 4-8 weeks
Change in hematoma volume in mL according to CT-scan-based volume measurements comparing hematoma on CT scan performed at 4-8 weeks to hematoma on immediate post-operative CT scan.
8 secondary outcomes
Chronic subdural hematoma volume change
Time frame: At 12 weeks
Rate of adverse events (AEs)
Time frame: At 4, 8, and 12 weeks
36-Item Short Form Survey (SF-36)
Time frame: At 4, 8, 12 weeks
National Institutes of Health Stroke Scale (NIHSS)
Time frame: At 4, 8, and 12 weeks
Modified Rankin Scale (mRS)
Time frame: At 4, 8, and 12 weeks
Markwalder's grading scale (MGS)
Time frame: At 4, 8, and 12 weeks
Rate of re-operation
Time frame: At 4, 8, and 12 weeks
Time to reoperation
Time frame: At 4, 8, and 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2021.
- 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. This study is not recruiting at the moment.
Michael D Cusimano, MD, PhD principal investigator
St. Michael's Hospital / University of Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tranexamic Acid 500 MG in people with Chronic 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 3 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 24 May 2021. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael D Cusimano, MD, PhD ((+1)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?
Chronic subdural hematoma volume change (time frame: At 4-8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 May 2021.