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

NCT05551871 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2022-10-10

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Simvastatin

the patient will receive Simvastatin for 7 days

DRUG

Placebo drug

the patient will receive Placebo drug for 7 days

Sponsors & Collaborators

  • Assiut University

    lead OTHER

Principal Investigators

  • Emad Zarief Kamel, MD · Assiut University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05551871 on ClinicalTrials.gov