Tranexamic Acid in Chronic Subdural Hematomas

Who is this study for? Patients with Chronic Subdural Hematoma
What treatments are being studied? Tranexamic Acid
Status: Recruiting
Location: See all (3) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
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 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:

• CT scan demonstrating the existence of a subdural hematoma containing a chronic component

• Diagnosis within the last 14 days

Locations
Other Locations
Canada
University of Alberta Hospital
Recruiting
Edmonton
Centre Hospitalier Affilié Universitaire de Québec
Recruiting
Québec
Centre Hospitalier Universitaire de Sherbrooke
Recruiting
Sherbrooke
Contact Information
Primary
David Mathieu, M.D.
david.mathieu@usherbrooke.ca
1 (819) 346-1110
Time Frame
Start Date: November 2015
Estimated Completion Date: June 2025
Participants
Target number of participants: 130
Treatments
Experimental: Tranexamic acid
Tranexamic acid 750 mg daily until complete radiological resolution of the chronic subdural hematoma or a maximum of 20 weeks.
Placebo Comparator: Placebo
Placebo tablet daily until complete radiological resolution of the chronic subdural hematoma or a maximum of 20 weeks.
Sponsors
Collaborators: Université de Sherbrooke
Leads: Centre de recherche du Centre hospitalier universitaire de Sherbrooke

This content was sourced from clinicaltrials.gov

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