Chronic Subdural HematomaPhase 2/3TRACSNCT02568124
Tranexamic Acid in Chronic Subdural Hematomas
A Phase 2/3 study testing Tranexamic Acid in people with Chronic Subdural Hematoma, run by Centre de recherche du Centre hospitalier universitaire de Sherbrooke at 3 sites in Canada.
Trial summary
BACKGROUND Chronic subdural hematoma (CSDH) is one of the most frequent reasons for cranial neurosurgical consult. There is no widely accepted medical treatment for CSDH. This trial will investigate whether Tranexamic Acid (TXA) can increase the rate of CSDH resolution following conservative management, lower the… 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
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 130 participants
- Where
- 3 sitesCanada
- Study dates
- Nov 2015to Jun 2025
- Phase
- Phase 2/3
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- CT scan demonstrating the existence of a subdural hematoma containing a chronic component
- Diagnosis within the last 14 days
Who cannot join
- Acute subdural hematoma with no chronic component;
- Active thrombotic, thromboembolic or atheroembolic disease, including deep venous thrombosis within the last six months, cerebral thrombosis within the last six months, symptomatic carotid stenosis who did not undergo surgery or stroke within the last year;
- Past history of unprovoked deep venous thrombosis or idiopathic pulmonary embolism;
- Known hereditary thrombophilia, including Factor V Leiden, Antithrombin III mutation, Protein C deficiency, Protein S deficiency;
- Atrial fibrillation (unless under successful rhythm control therapy);
- Metallic heart valve;
Show all 17Show fewer
- Vascular stenting procedure within the last year;
- Cardiac or vascular surgical procedure within the last 6 months, including endarterectomy, bypass or angioplasty;
- Ongoing investigation for suspected malignancy;
- Confirmed active malignancy;
- Concomitant hormone therapy for malignancy;
- Concomitant hormone contraceptive pill;
- Macroscopic hematuria;
- Known or suspected tranexamic acid allergy;
- Pregnancy or breastfeeding;
- Concomitant use of anticoagulant medication;
- Any concern from the attending physician.
Trial locations and contacts
3 sites in 1 country.
Canada3 sites, 3 recruiting
- Recruiting
University of Alberta Hospital
Edmonton, Alberta, T6G 2B7
Sudeshna Bhattacharya, 780 934-0280, sbhattac@ualberta.ca
Tim Darsaut
- Recruiting
Centre Hospitalier Affilié Universitaire de Québec
Québec, G1J 1Z4
Paule Lessard-Bonaventure, M.D., 1 (418) 649-0252, paule.lessard-bonaventure.1@ulaval.ca
Paule Lessard-Bonaventure, M.D.
- Recruiting
Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke, Quebec, J1H 5N4
Christian Iorio-Morin, M.D., Ph.D., 1 (819) 346-1110, christian.iorio-morin@usherbrooke.ca
Christian Iorio-Morin, M.D., Ph.D.
About this study
BACKGROUND Chronic subdural hematoma (CSDH) is one of the most frequent reasons for cranial neurosurgical consult. There is no widely accepted medical treatment for CSDH.
This trial will investigate whether Tranexamic Acid (TXA) can increase the rate of CSDH resolution following conservative management, lower the number of required surgical procedures and decrease the rate of CSDH recurrence following surgical evacuation. TRACS is a double blind, randomized, parallel-design, placebo-controlled, phase IIB study designed to provide preliminary efficacy data as well as feasibility, safety and incidence data required to plan a larger definitive phase III trial.
Read more
METHODS Consecutive patients presenting at the Centre Hospitalier Universitaire de Sherbrooke with a recent (< 14 days) diagnosis of subdural hematoma with a chronic component will be screened for eligibility. Exclusion criteria include specific risk factors for thromboembolic disease, anticoagulant use or contraindication to TXA. A total of 130 patients will be randomized to receive either 750 mg of TXA daily or placebo until complete radiological resolution of the CSDH or for a maximum of 20 weeks. CSDH volume will be measured on serial CT scanning. Cognitive function tests, quality of life questionnaires as well as functional autonomy assessments will be performed at enrollment, 10 weeks follow-up and 3 months post-treatment follow-up. During the treatment period, patients will undergo standard CSDH management with surgery being performed at the discretion of the treating physician. If surgery is performed, the CSDH and its outer membrane will be sampled for in vitro analysis.
The primary outcome is the rate of CSDH resolution at 20 weeks without intervening unplanned surgical procedure. Secondary outcomes include CSDH volume, incidence of surgical evacuation procedures, CSDH recurrence, cognitive functions, functional autonomy, quality of life, incidence of complications and length of hospital stay. Planned subgroup analyses will be performed for conservatively vs surgically-managed subjects and highly vs poorly vascularised CSDH.
DISCUSSION CSDH is a frequent and morbid condition for which an effective medical treatment has yet to be discovered. The TRACS trial will be the first prospective study of TXA for CSDH.
- Conditions
- Chronic Subdural Hematoma
- Being tested
- Tranexamic Acid, Placebo
- Keywords
- Tranexamic acid, Cyklokapron, Conservative management, Medical management
- 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 AcidDrug
Also called Cyklokapron
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Tranexamic acid | Experimental | Tranexamic acid 750 mg daily until complete radiological resolution of the chronic subdural hematoma or a maximum of 20 weeks. Receives: Drug: Tranexamic Acid |
| Placebo | Placebo comparator | Placebo tablet daily until complete radiological resolution of the chronic subdural hematoma or a maximum of 20 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hematoma resolution
The rate of chronic subdural hematoma resolution without intervening unplanned surgical procedure. Specifically, if the initial management strategy chosen by the attending physician within the first 24 hours of presentation consists of expectant management, any surgical procedure leads to a failure of meeting the primary outcome. On the other hand, if the management strategy chosen by the attending physician within the first 24 hours of presentation included a surgical evacuation of the CSDH, the primary outcome is met if the control CT scan at 20 weeks demonstrates a complete radiological resolution of the CSDH. Should a second surgery be required, the subject will fail to meet the primary outcome even if the CSDH has completely resolved by 20 weeks.
Measured: 20 weeks
Secondary outcomes (12)
Hematoma volume
Measured by segmentation analysis on the 20 weeks CT scan
Measured: 20 weeks
Surgical evacuation
The incidence of surgical evacuation procedures
Measured: 32 weeks
Hematoma recurrence
Measured: 32 weeks
Cognitive function
Assessed by the Montreal Cognitive Assessment (MoCA) and Mini-Mental State Examination (MMSE)
Measured: 10 weeks
Cognitive function
Assessed by the Montreal Cognitive Assessment (MoCA) and Mini-Mental State Examination (MMSE)
Measured: 32 weeks
Functional autonomy
Assessed by the modified Barthel Index (mBI) and Glasgow Outcome Scale Extended (GOSE)
Measured: 10 weeks
Functional autonomy
Assessed by the modified Barthel Index (mBI) and Glasgow Outcome Scale Extended (GOSE)
Measured: 32 weeks
Quality of life scores at 10 weeks
Assessed by the EQ-5D-5L and the Sherbrooke Neuro-oncology Assessment Scale (SNAS)
Measured: 10 weeks
Quality of life scores at 32 weeks
Assessed by the EQ-5D-5L and the Sherbrooke Neuro-oncology Assessment Scale (SNAS)
Measured: 32 weeks
Length initial of hospital stay
Measured: 32 weeks
Number of rehospitalisation
Measured: 32 weeks
Complications
Incidence of any complication related to tranexamic acid administration
Measured: 32 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2015 (estimated)
- Study startNov 2015
- Primary completionDec 2024 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Subdural HematomaStudies of the same condition, open and under way.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre de recherche du Centre hospitalier universitaire de Sherbrooke
- Sponsor type
- University, hospital or other
- Collaborators
- Université de Sherbrooke
- Responsible party
- Principal investigator, Dr David Mathieu, Centre de recherche du Centre hospitalier universitaire de Sherbrooke
- Investigators
- David Mathieu, M.D., Principal investigator, Université de Sherbrooke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02568124
- Sponsor's protocol ID
- 14-213
- Acronym
- TRACS
- Status last verified
- Aug 2023
- First submitted
- 1 Oct 2015
- Last updated
- 5 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Publications
Iorio-Morin C, Blanchard J, Richer M, Mathieu D. Tranexamic Acid in Chronic Subdural Hematomas (TRACS): study protocol for a randomized controlled trial. Trials. 2016 May 5;17(1):235. doi: 10.1186/s13063-016-1358-5.
PubMed 27150916
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tranexamic Acid in Chronic Subdural Hematomas
- ClinicalTrials.gov ID
- NCT02568124
- Acronym / sponsor ID
- TRACS / 14-213
- Conditions
- Chronic Subdural Hematoma
- Keywords
- Tranexamic acid, Cyklokapron, Conservative management, Medical management
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Centre de recherche du Centre hospitalier universitaire de SherbrookeUniversity, hospital or other
- Collaborators
- Université de Sherbrooke
- Study start
- Nov 2015
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 5 Oct 2015 (estimated)
- 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.
BACKGROUND Chronic subdural hematoma (CSDH) is one of the most frequent reasons for cranial neurosurgical consult. There is no widely accepted medical treatment for CSDH.
This trial will investigate whether Tranexamic Acid (TXA) can increase the rate of CSDH resolution following conservative management, lower the number of required surgical procedures and decrease the rate of CSDH recurrence following surgical evacuation. TRACS is a double blind, randomized, parallel-design, placebo-controlled, phase IIB study designed to provide preliminary efficacy data as well as feasibility, safety and incidence data required to plan a larger definitive phase III trial.
METHODS Consecutive patients presenting at the Centre Hospitalier Universitaire de Sherbrooke with a recent (< 14 days) diagnosis of subdural hematoma with a chronic component will be screened for eligibility. Exclusion criteria include specific risk factors for thromboembolic disease, anticoagulant use or contraindication to TXA. A total of 130 patients will be randomized to receive either 750 mg of TXA daily or placebo until complete radiological resolution of the CSDH or for a maximum of 20 weeks. CSDH volume will be measured on serial CT scanning. Cognitive function tests, quality of life questionnaires as well as functional autonomy assessments will be performed at enrollment, 10 weeks follow-up and 3 months post-treatment follow-up. During the treatment period, patients will undergo standard CSDH management with surgery being performed at the discretion of the treating physician. If surgery is performed, the CSDH and its outer membrane will be sampled for in vitro analysis.
The primary outcome is the rate of CSDH resolution at 20 weeks without intervening unplanned surgical procedure. Secondary outcomes include CSDH volume, incidence of surgical evacuation procedures, CSDH recurrence, cognitive functions, functional autonomy, quality of life, incidence of complications and length of hospital stay. Planned subgroup analyses will be performed for conservatively vs surgically-managed subjects and highly vs poorly vascularised CSDH.
DISCUSSION CSDH is a frequent and morbid condition for which an effective medical treatment has yet to be discovered. The TRACS trial will be the first prospective study of TXA for CSDH.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tranexamic acid | Experimental | Drug: Tranexamic AcidTranexamic acid 750 mg daily until complete radiological resolution of the chronic subdural hematoma or a maximum of 20 weeks. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo tablet daily until complete radiological resolution of the chronic subdural hematoma or a maximum of 20 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- CT scan demonstrating the existence of a subdural hematoma containing a chronic component
- Diagnosis within the last 14 days
Key exclusion criteria (17 listed)
- Acute subdural hematoma with no chronic component;
- Active thrombotic, thromboembolic or atheroembolic disease, including deep venous thrombosis within the last six months, cerebral thrombosis within the last six months, symptomatic carotid stenosis who did not undergo surgery or stroke within the last year;
- Past history of unprovoked deep venous thrombosis or idiopathic pulmonary embolism;
- Known hereditary thrombophilia, including Factor V Leiden, Antithrombin III mutation, Protein C deficiency, Protein S deficiency;
- Atrial fibrillation (unless under successful rhythm control therapy);
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 AcidAlso: Cyklokapron | Drug | Tranexamic acid |
| Placebo | Drug | Placebo |
Primary outcome
Hematoma resolution
Time frame: 20 weeks
The rate of chronic subdural hematoma resolution without intervening unplanned surgical procedure. Specifically, if the initial management strategy chosen by the attending physician within the first 24 hours of presentation consists of expectant management, any surgical procedure leads to a failure of meeting the primary outcome. On the other hand, if the management strategy chosen by the attending physician within the first 24 hours of presentation included a surgical evacuation of the CSDH, the primary outcome is met if the control CT scan at 20 weeks demonstrates a complete radiological resolution of the CSDH. Should a second surgery be required, the subject will fail to meet the primary outcome even if the CSDH has completely resolved by 20 weeks.
12 secondary outcomes
Hematoma volume
Time frame: 20 weeks
Surgical evacuation
Time frame: 32 weeks
Hematoma recurrence
Time frame: 32 weeks
Cognitive function
Time frame: 10 weeks
Cognitive function
Time frame: 32 weeks
Functional autonomy
Time frame: 10 weeks
Functional autonomy
Time frame: 32 weeks
Quality of life scores at 10 weeks
Time frame: 10 weeks
Quality of life scores at 32 weeks
Time frame: 32 weeks
Length initial of hospital stay
Time frame: 32 weeks
Number of rehospitalisation
Time frame: 32 weeks
Complications
Time frame: 32 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2023.
- Derived from this study: PubMed 27150916Iorio-Morin C, Blanchard J, Richer M, Mathieu D. Tranexamic Acid in Chronic Subdural Hematomas (TRACS): study protocol for a randomized controlled trial. Trials. 2016 May 5;17(1):235. doi: 10.1186/s13063-016-1358-5.
- Individual participant dataSharing planned: Yes
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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.
David Mathieu, M.D. principal investigator
Université de Sherbrooke
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Tranexamic Acid in people with Chronic Subdural Hematoma, run by Centre de recherche du Centre hospitalier universitaire de Sherbrooke at 3 sites 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 2 inclusion and 17 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 5 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 combined 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.
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 David Mathieu, M.D. (1 (819) 346-1110 ext. 74887, david.mathieu@usherbrooke.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hematoma resolution (time frame: 20 weeks). 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 NCT02568124, which also lists 1 linked publication.
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 5 Sep 2023.