Biperideno na prevenção de epilepsia em pacientes com traumatismo cranioencefálico em Sobral-Ceará: impacto do fluxo de atendimento na condução do ensaio clínico e na assistência aos pacientes do SUS

Abstract

Traumatic brain injury (TBI) constitutes a major public health problem in Brazil, with high incidence, morbidity and mortality, and significant socioeconomic impact. Among the sequelae of TBI are acute epileptic seizures and post-traumatic epilepsy. There are no effective therapies to prevent post-traumatic epilepsy. Biperiden, a muscarinic antagonist, has shown evidence of reducing and delaying seizures in animal models, and clinical trials in humans have demonstrated the drug’s safety, although its preventive efficacy has not yet been established. The development of TBI-targeted therapies depends on scientific evidence and adequate healthcare conditions that enable the conduct of clinical studies. This thesis aimed to identify and analyze aspects of the care pathway for patients with TBI in the Northern macro-region of Ceará that impacted both patient care and the conduct of a clinical trial, focusing on the study “Biperiden for the Prevention of Post-Traumatic Epilepsy.” This is an observational study with prospective data collection that evaluated 294 patients screened between September 2023 and December 2024 at Santa Casa de Misericórdia de Sobral, a trauma referral hospital in the interior of the state of Ceará. Patients diagnosed with skull and facial bone fractures, intracranial trauma, and/or crushing head injuries were included. Variables related to epidemiological profile, clinical severity, time intervals in care, and completeness of clinical records produced throughout the access pathway were analyzed. The results indicated a predominance of young male victims, mostly involved in motorcycle accidents. Essential information for clinical management and trial eligibility was frequently missing, such as time of trauma (28,2% of cases), time of admission to the first care unit (49,1%), and Glasgow Coma Scale (GCS) records at the scene (80,3%) and at the first care unit (27,1%). Sedated patients arrived more quickly at specialized services, suggesting prioritization of severe cases. Inconsistencies were also identified in the standardization of information transferred between services, possibly

associated with structural limitations of the electronic systems used and the absence of well- defined institutional protocols. It was further observed that the time between trauma and arrival

at the referral hospital correlated with geographic distance and severity of the condition, but may also have been influenced by regulatory barriers and communication failures. These factors directly affected participant inclusion in the clinical trial, especially due to the protocol requirement of administering the first dose of the intervention within 18 hours after trauma. Thus, although the regional access pathway for trauma patients is structured, deficiencies in the recording of critical information and delays in care compromised Santa Casa’s greater participation in the clinical trial, particularly due to the late arrival of patients outside the therapeutic window. These findings highlight the need for team training, documentation standardization, and the adoption of technological strategies that enhance interinstitutional communication, contributing not only to the feasibility of future multicenter studies but also to the improvement of healthcare delivery itself.