Chronic Subdural HematomaPhase 3TRACENCT03280212
Tranexamic Acid in the Treatment of Residual Chronic Subdural Hematoma
A Phase 3 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) is a common disease after minor head trauma, especially in elderly patients. This medical condition is characterized by blood collection in the subdural space, which can result in severe neurological impairment. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Subdural Hematoma
- What is being tested?
- Tranexamic Acid 500 MG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- 6 Mar 2017to Mar 2018
- Phase
- Phase 3
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients diagnosed with chronic subdural hematoma, and have a planned or have received a unilateral or bilateral burr-hole craniostomy or mini-craniotomy
- Written informed consent (patient, power of attorney or substitute decision maker)
- Competence to take study medication properly and regularly or access to care giver 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 glomerular filtration rate (GFR) ≤ 30 mL/min
- Hematuria, caused by diseases of renal parenchyma
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- Current alcohol abuse (as indicated by an Alcohol Use Disorders Identification Test (AUDIT) score of 10 or higher) drug abuse, or recreational drug use
- Concomitant intake of hormonal contraceptives, factor IX complex concentrates, and anti-inhibitor coagulant concentrates (factor VII, activated factor IX)
- Active, history, or increased risk of thrombotic events (including deep vein thrombosis, pulmonary embolism, cerebral venous thrombosis, arterial thrombotic events), symptomatic carotid stenosis, myocardial infarction, acute coronary syndrome, coronary artery disease, or consumption coagulopathy within the past 2 years
- History of angioplasty with cardiac stent placement or mechanical heart valve
- Active or history of brain pathologies such as stroke (hemorrhagic and ischemic), subarachnoid hemorrhage, or malignant brain tumors (glioma, metastasis and others) as well as history of seizures within the past 2 years
- Contraindication to stopping full therapeutic doses of non-acetylsalicylic acid (ASA) antiplatelets, warfarin, rivaroxaban, apixaban, dabigatran, or other anticoagulant for 2 weeks after surgery
- Patients requiring immediate revision surgery (as defined by attending surgeon)
- Inability of oral drug intake or missing support to guarantee oral drug intake
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
St. Michael's Hospital
Toronto, Ontario, M5B 1W8
Adriana M Workewych, HBSc, 416-864-5312, workewycha@smh.ca
Michael D Cusimano, Md, PhD
About this study
Official title: Tranexamic Acid in the Treatment of Residual Chronic Subdural Hematoma: A Single-centre, Observer-blinded, Randomized Controlled Trial.
Chronic subdural hematoma (CSDH) is a common disease after minor head trauma, especially in elderly patients. This medical condition is characterized by blood collection in the subdural space, which can result in severe neurological impairment. Current standard of care is the evacuation of the CSDH by means of different surgical approaches. Although clinical and surgical outcomes are satisfying in most cases, considerable morbidity and mortality as well as recurrence rates of 3-31% are frequently reported. Therefore a non-surgical approach for the treatment of CSDH would be desirable. Tranexamic acid (TXA), an antifibrinolytic drug has been shown to decrease hematoma volume in a small cohort of patients suffering from CSDH. 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 during study course to quantify treatment success. The trial is designed as a randomized controlled pilot study, where half of the patients will be assigned to daily intake of TXA, whereas the other half will receive medical treatment according to current practice without TXA prescription. The primary endpoint of the study is defined as volume change in milliliters (mL) after 4-8 weeks of treatment. Secondary endpoints are hematoma volume change at 8-12 weeks, the rate of patients with resolution of the CSDH after 4-8 weeks and 8-12 weeks days, as well as the rate of reoperation during study course due to hematoma extension and neurological deterioration. Additionally the neurological outcome and the drug compatibility will be estimated as secondary objectives.
- Conditions
- Chronic Subdural Hematoma
- Being tested
- Tranexamic Acid 500 MG
- Keywords
- Chronic subdural hematoma, Tranexamic acid, TXA
- 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
Also called TXA
Tranexamic Acid 500mg oral tablets.
| Study group | Role | What they receive |
|---|---|---|
| Tranexamic Acid Arm | Experimental | Tranexamic Acid 500 milligrams (MG)
Participants of the Tranexamic Acid (TXA) arm will receive the study drug, TXA. Participants of average body weight (60-100kg) will receive TXA according to a 500mg three times daily (TID) dose regimen. Weight deviations from this range will see dose adjustments as follows: participants <60kg will receive 500mg two times daily (BID), and participants >100kg will receive 1000mg BID. Receives: Drug: Tranexamic Acid 500 MG |
| Control Arm | No intervention | No intervention Participants in the control arm will not receive any additional intervention, medication, or placebo, and will serve as a comparative arm for the experimental arm. |
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 volume measurements made on CT scans comparing CT scan at 4-8 weeks to immediate post-operative CT scan.
Measured: 4-8 weeks, 8-12 weeks
Secondary outcomes (4)
Neurological outcome
An assessment of neurological outcome as measured by the National Institutes of Health Stroke Scale (NIHSS)
Measured: 4-8 weeks, 8-12 weeks
Quality of life
Participants quality of life as measured on the Health Utilities Index (HUI).
Measured: 4-8 weeks, 8-12 weeks
Quality of life
Participants quality of life as measured on the 36-item Short Form Health Survey (SF-36).
Measured: 4-8 weeks, 8-12 weeks
Occurrence of adverse events
Safety of the TXA dose regimen by monitoring incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Measured: 4-8 weeks, 8-12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2017
- Study start6 Mar 2017
- Primary completionMar 2018 (estimated)
- Study completionMar 2018 (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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Cusimano, Unity Health Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03280212
- Sponsor's protocol ID
- 14-0176-GAP
- Acronym
- TRACE
- Status last verified
- Sep 2017
- First submitted
- 10 Sep 2017
- Last updated
- 14 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2017. 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: A Single-centre, Observer-blinded, Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT03280212
- Acronym / sponsor ID
- TRACE / 14-0176-GAP
- Conditions
- Chronic Subdural Hematoma
- Keywords
- Chronic subdural hematoma, Tranexamic acid, TXA
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Study start
- 6 Mar 2017 (actual)
- Primary completion
- Mar 2018 (estimated)
- Study completion
- Mar 2018 (estimated)
- First posted
- 12 Sep 2017 (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) is a common disease after minor head trauma, especially in elderly patients. This medical condition is characterized by blood collection in the subdural space, which can result in severe neurological impairment. Current standard of care is the evacuation of the CSDH by means of different surgical approaches. Although clinical and surgical outcomes are satisfying in most cases, considerable morbidity and mortality as well as recurrence rates of 3-31% are frequently reported. Therefore a non-surgical approach for the treatment of CSDH would be desirable. Tranexamic acid (TXA), an antifibrinolytic drug has been shown to decrease hematoma volume in a small cohort of patients suffering from CSDH. 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 during study course to quantify treatment success. The trial is designed as a randomized controlled pilot study, where half of the patients will be assigned to daily intake of TXA, whereas the other half will receive medical treatment according to current practice without TXA prescription. The primary endpoint of the study is defined as volume change in milliliters (mL) after 4-8 weeks of treatment. Secondary endpoints are hematoma volume change at 8-12 weeks, the rate of patients with resolution of the CSDH after 4-8 weeks and 8-12 weeks days, as well as the rate of reoperation during study course due to hematoma extension and neurological deterioration. Additionally the neurological outcome and the drug compatibility will be estimated as secondary objectives.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tranexamic Acid Arm | Experimental | Drug: Tranexamic Acid 500 MGTranexamic Acid 500 milligrams (MG) Participants of the Tranexamic Acid (TXA) arm will receive the study drug, TXA. Participants of average body weight (60-100kg) will receive TXA according to a 500mg three times daily (TID) dose regimen. Weight deviations from this range will see dose adjustments as follows: participants <60kg will receive 500mg two times daily (BID), and participants >100kg will receive 1000mg BID. |
| Control Arm | No intervention | –No intervention Participants in the control arm will not receive any additional intervention, medication, or placebo, and will serve as a comparative arm for the experimental arm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients diagnosed with chronic subdural hematoma, and have a planned or have received a unilateral or bilateral burr-hole craniostomy or mini-craniotomy
- Written informed consent (patient, power of attorney or substitute decision maker)
- Competence to take study medication properly and regularly or access to care giver 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 glomerular filtration rate (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 MGAlso: TXATranexamic Acid 500mg oral tablets. | Drug | Tranexamic Acid Arm |
Primary outcome
Chronic subdural hematoma volume change
Time frame: 4-8 weeks, 8-12 weeks
Change in hematoma volume in mL according to volume measurements made on CT scans comparing CT scan at 4-8 weeks to immediate post-operative CT scan.
4 secondary outcomes
Neurological outcome
Time frame: 4-8 weeks, 8-12 weeks
Quality of life
Time frame: 4-8 weeks, 8-12 weeks
Quality of life
Time frame: 4-8 weeks, 8-12 weeks
Occurrence of adverse events
Time frame: 4-8 weeks, 8-12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2017.
- Individual participant dataSharing planned: Undecided
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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.
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 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 14 Sep 2017. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Adriana M Workewych, HBSc (416-864-5312, workewycha@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: 4-8 weeks, 8-12 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 14 Sep 2017.