Tranexamic Acid in Chronic Subdural Hematomas (TRACS): study protocol for a randomized controlled trial.

ABSTRACT:

Background

Chronic 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.

Methods

TRACS 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. Co

SUBMITTER: Iorio-Morin C 

PROVIDER: S-EPMC4857422 | biostudies-literature | 2016 May

REPOSITORIES: biostudies-literature