A Phase 2/3 interventional study of Tranexamic Acid and Placebo in Chronic Subdural Hematoma, sponsored by Centre de recherche du Centre hospitalier universitaire de Sherbrooke. Recruiting at 3 sites in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-09-05.
Sponsored by Centre de recherche du Centre hospitalier universitaire de Sherbrooke · Phase 2/3, Interventional, and Treatment
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.
112 studies on the registry are indexed under Hematoma, Subdural, Chronic; 49 are open to participants now.
This study's planned enrollment of 130 is below the median of 185 across 86 interventional studies indexed under Hematoma, Subdural, Chronic.
Browse Hematoma, Subdural, Chronic studies →Centre de recherche du Centre hospitalier universitaire de Sherbrooke is the lead sponsor of 29 studies on the registry; 10 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
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Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
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Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
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Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Tranexamic acid 750 mg daily until complete radiological resolution of the chronic subdural hematoma or a maximum of 20 weeks.
Drug: Tranexamic Acid
Placebo tablet daily until complete radiological resolution of the chronic subdural hematoma or a maximum of 20 weeks.
Drug: Placebo
Also known as: Cyklokapron
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.
Time frame: 20 weeks
Hematoma volume
Measured by segmentation analysis on the 20 weeks CT scan
Time frame: 20 weeks
Surgical evacuation
The incidence of surgical evacuation procedures
Time frame: 32 weeks
Hematoma recurrence
Time frame: 32 weeks
Cognitive function
Assessed by the Montreal Cognitive Assessment (MoCA) and Mini-Mental State Examination (MMSE)
Time frame: 10 weeks
Cognitive function
Assessed by the Montreal Cognitive Assessment (MoCA) and Mini-Mental State Examination (MMSE)
Time frame: 32 weeks
Functional autonomy
Assessed by the modified Barthel Index (mBI) and Glasgow Outcome Scale Extended (GOSE)
Time frame: 10 weeks
Functional autonomy
Assessed by the modified Barthel Index (mBI) and Glasgow Outcome Scale Extended (GOSE)
Time frame: 32 weeks
Quality of life scores at 10 weeks
Assessed by the EQ-5D-5L and the Sherbrooke Neuro-oncology Assessment Scale (SNAS)
Time frame: 10 weeks
Quality of life scores at 32 weeks
Assessed by the EQ-5D-5L and the Sherbrooke Neuro-oncology Assessment Scale (SNAS)
Time frame: 32 weeks
Length initial of hospital stay
Time frame: 32 weeks
Number of rehospitalisation
Time frame: 32 weeks
Complications
Incidence of any complication related to tranexamic acid administration
Time frame: 32 weeks
Plan to share: Yes
The record gives a start of Nov 2015, a primary completion of Dec 2024 and a completion of Jun 2025. It does not say whether these dates are actual or estimated.
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Studies of the drug tested here: Tranexamic Acid
Centre de recherche du Centre hospitalier universitaire de Sherbrooke