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Cerebrovascular Injury Antithrombotic Therapy in Trauma: An EAST Multicenter Trial Study of Stroke Prophylaxis in Blunt Cerebrovascular Injury (BCVI)

Detalles del proyecto

Description

There has yet to be a large prospective trial comparing the efficacy of aspirin and systemic anticoagulation in patients with BCVI. Such a study is warranted to determine which therapy provides the best stroke prophylaxis while minimizing associated sequalae and cost. Due to liberal screening protocols and timely prophylaxis, the incidence of stroke in trauma patients with BCVI is rare. As such, a common limitation of studies of BCVI-related stroke are small sample sizes and retrospective designs. However, the diagnosis of BCVI is more frequently made today, making the clinical question of aspirin versus systemic anticoagulation common in the surgical ICU. The study of BCVI related stroke is ideally suited for a prospective multi-center observational trial. Both treatments, aspirin and systemic anti-coagulation (typically IV Heparin), are considered to be standard of care treatment in injured patients with BCVI. Therefore, participation in this study requires no deviation from existing standard of care, presenting no more than minimal risk to research subjects. Conducting this study with the cooperation of multiple trauma centers is critical to achieving the required sample size necessary to determine clinical superiority in a low-incidence disease process such as BCVI related stroke. A large prospective study has the potential to determine preferred stroke prophylaxis in patients with BCVI as well as to help minimize potential therapy related sequela. Additionally, the reduced use of IV systemic anticoagulation presents the opportunity to reduce hospital cost and nursing staff burden due to less expensive and time-consuming therapy and monitoring.
EstadoActivo
Fecha de inicio/Fecha fin7/1/256/30/26

Financiación

  • Eastern Association for the Surgery of Trauma (EAST): 10.000,00 US$

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