Abstract
BackgroundChronic subdural hematoma (CSDH) is one of the most frequent reason for cranial neurosurgical consultation. There is no widely accepted medical treatment for this condition. Herein, we present the protocol for the Tranexamic Acid (TXA) in Chronic Subdural Hematomas (TRACS) trial aiming at determining whether 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.MethodsTRACS is a multicenter, 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.Consecutive patients presenting with a diagnosis of chronic subdural hematoma 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 computed tomography (CT) scanning. Cognitive function tests, quality of life questionnaires as well as functional autonomy assessments will be performed at enrollment, at 10 weeks following randomization and at 3 months following treatment cessation. 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 by 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 versus surgically managed subjects and highly versus poorly vascularized CSDH.DiscussionCSDH is a frequent morbidity for which an effective medical treatment has yet to be discovered. The TRACS trial will be the first prospective study of TXA for CSDH.Trial registrationNCT ID: NCT02568124.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-016-1358-5) contains supplementary material, which is available to authorized users.
Highlights
Chronic subdural hematoma (CSDH) is one of the most frequent reason for cranial neurosurgical consultation
It is postulated that activation of fibrinolysis within the hematoma might sustain a local coagulopathy which would promote low-volume bleeding from the outer membrane of the clot [3, 4]
We will be conducting a phase IIB trial, called “Tranexamic Acid in Chronic Subdural Hematomas” (TRACS), to investigate whether 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
Summary
Overview TRACS is a double-blinded, randomized, parallel-design, placebo-controlled trial investigating the effect of longterm (up to 20 weeks) TXA administration on CSDH resolution when used as an adjunct to standard management. Rates of complete radiological resolution following surgery have been reported to be between 70 and 95 % [18] with only 3– 18 % of cases resolving spontaneously if conservative management is undertaken [6] Using these data, if we postulate that 30 % of patients enrolled in the study will undergo surgical evacuation, the primary outcome in the placebo group should be met in 23–41 %. Safety TRACS’ protocol requires discontinuation of TXA administration at the first CT scan demonstrating complete CSDH radiological resolution rather than at a fixed 20week time point This design decision will result in variable treatment duration and time of primary outcome assessment within the cohort.
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