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

Trials
Christian Iorio-MorinDavid Mathieu

Abstract

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. 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. 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. ...Continue Reading

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References

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Citations

Dec 3, 2016·Journal of the International Association of Providers of AIDS Care·Raja K KuttyM Anilkumar
Aug 4, 2018·Journal of Neurotrauma·Christian Iorio-MorinDavid Mathieu
Jan 7, 2018·Neurocritical Care·Eelco F M Wijdicks
Jan 26, 2018·Medizinische Klinik, Intensivmedizin und Notfallmedizin·J WaskowskiF Stueber
Mar 6, 2019·Journal of Neurosurgery·Ambuj Kumar, Yad Ram Yadav
Feb 7, 2020·Acta neurochirurgica·E EdlmannUNKNOWN International Collaborative Research Initiative on Chronic Subdural Haematoma (iCORIC) study group
Jun 25, 2018·Current Treatment Options in Neurology·Elena I FomchenkoKevin N Sheth
Jun 1, 2017·Journal of Neuroinflammation·Ellie EdlmannPeter J Hutchinson
Jan 29, 2021·Complementary Therapies in Clinical Practice·Seungwon KwonKi-Ho Cho
May 18, 2018·World Neurosurgery·Dana C HollUNKNOWN Dutch Chronic Subdural Hematoma Research Group (DSHR)

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Clinical Trials Mentioned

NCT02111785
NCT02192320
NCT01380028
NCT00915928
NCT02568124

Software Mentioned

Osirix

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