drugset / Trial / NCT05551871

Effects of Usage of Simvastatin in Mild to Moderate Traumatic Brain Injury (TBI) Patients. Could it Make a Difference?

NCT05551871

Unknown 60 enrolled Assiut University
RandomizedParallel-groupDouble-blindTreatment

Summary

Traumatic brain injury (TBI) is a common cause of long-term neurological morbidity, with devastating personal and societal consequences. At present, no pharmacological intervention clearly improves outcomes, and therefore a compelling unmet clinical need remains. 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors, or "statins," offer a potential novel therapeutic strategy for TBI. In this study the investigators will study primarily the effect of statins on 30-day mortality rate which is defined as death within 30 days of TBI presentation where the occurrence of TBI is hour 0 or day 0 and secondarily evaluation of duration of ICU stay associated with or without complications.

Timeline

Start
2022-10-01
Primary completion
2023-12-01
Completion
2023-12-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Simvastatin Small molecule 40 mg