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Venous thrombosis requires effective prevention and treatment strategies to improve patient outcomes and reduce potential complications.Prevention StrategiesHealthcare providers must prioritize preventing venous thromboembolism (VTE) for all adult patients upon admission. Interventions depend on bleeding and thrombosis risk, medical history, current medications, diagnoses, planned procedures, and patient preferences. Patients on bed rest should change positions every two hours and, if not...
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Related Experiment Video

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

Christian Iorio-Morin1, Jocelyn Blanchard2, Maxime Richer3

  • 1Division of Neurosurgery, Department of Surgery, Centre Hospitalier Universitaire de Sherbrooke, 3001, 12e avenue Nord, Sherbrooke, QC, J1H 5N4, Canada. christian.iorio-morin@usherbrooke.ca.

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|May 7, 2016
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Summary

The TRACS trial investigates if tranexamic acid (TXA) can help resolve chronic subdural hematomas (CSDH) without surgery. This study aims to determine TXA

Keywords:
Chronic subdural hematomaConservative managementCyklokapronMedical managementNon-traumaticTranexamic acidTraumatic

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Area of Science:

  • Neurosurgery
  • Pharmacology
  • Clinical Trials

Background:

  • Chronic subdural hematoma (CSDH) is a common neurosurgical condition lacking effective medical treatments.
  • Current management relies on surgical evacuation, with recurrence and complications being significant concerns.
  • The TRACS trial protocol is presented to address the need for non-surgical therapeutic options for CSDH.

Purpose of the Study:

  • To evaluate the efficacy of tranexamic acid (TXA) in promoting CSDH resolution.
  • To assess TXA's potential to reduce the need for surgical intervention in CSDH patients.
  • To investigate TXA's impact on CSDH recurrence rates after surgical evacuation.

Main Methods:

  • A multicenter, double-blind, randomized, placebo-controlled phase IIB trial (TRACS) involving 130 patients.
  • Patients receive daily TXA (750 mg) or placebo until radiological resolution or for 20 weeks.
  • Outcomes include CSDH resolution rate, surgical procedure incidence, recurrence, cognitive function, and quality of life.

Main Results:

  • Preliminary efficacy, feasibility, safety, and incidence data will be collected.
  • Primary outcome: rate of CSDH resolution by 20 weeks without unplanned surgery.
  • Secondary outcomes assess CSDH volume, surgical rates, recurrence, and patient-reported outcomes.

Conclusions:

  • CSDH represents a significant clinical challenge with limited medical treatment options.
  • The TRACS trial is the first prospective study to investigate TXA for CSDH management.
  • Findings will inform the design of a larger phase III trial for definitive treatment recommendations.