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.
Phase:
Phase 2/Phase 3
Details
Lead Sponsor:
Centre de recherche du Centre hospitalier universitaire de Sherbrooke
Collaborators:
Centre Hospitalier Universitaire de Québec, CHU de Québec Université de Sherbrooke