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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04718155
Other study ID # IRB5566000
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 1, 2021
Est. completion date June 1, 2022

Study information

Verified date June 2022
Source Assiut University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

3-Hydroxy-3-methylglutaryl-coenzyme A reductase inhibitors, known as statins, are widely used to reduce levels of low-density lipoprotein-cholesterol. As lipid-lowering drugs, statins exert neuroprotective effects on ischemic stroke. this study will investigate whether the protective effect of statins is mediated by their ability to impact inflammation and oxygen free radical levels in cerebral ischemia/reperfusion injury. Could Statins affect the neuroinflamation which occurs after traumatic brain injury?


Description:

Traumatic brain injury (TBI) is one of the most common and financially devastating health problems in our society. Once the acute care period has ended, many TBI patients are left with motor, cognitive, or emotional dysfunction as a result of their injury. The treatment of TBI remains largely supportive, directed toward management of cerebral edema and intracranial hypertension via temporizing measures, such as administration of osmotic agents, hyperventilation, and ventricular drainage. None of these interventions have been definitively demonstrated to improve long-term functional outcome. The failure of preclinical therapies to translate into clinical benefit may derive from the heterogeneity of TBI pathology, which includes diffuse axonal injury, cerebral contusion, intracerebral hemorrhage (ICH), subarachnoid hemorrhage (SAH), and extra parenchymal hemorrhage. These primary insults are exacerbated by a secondary neuroinflammatory cascade of cerebral hypoperfusion and ischemia, oxidative stress, cerebral edema, and intracranial hypertension. There are a series of reactions following cerebral ischemia/reperfusion, such as inflammation and an increase in free radicals, which may trigger secondary injury in ischemic tissue. Indeed, the inhibition of inflammation reduces tissue damage in ischemia. Thus, understanding the roles of inflammation and free radicals in ischemia/reperfusion injury is therefore of great importance. 3-Hydroxy-3-methylglutaryl-coenzyme A reductase inhibitors, known as statins, are widely used to reduce levels of low-density lipoprotein-cholesterol. As lipid-lowering drugs, statins exert neuroprotective effects on ischemic stroke. In this study, teh study will investigate whether the protective effect of statins is mediated by their ability to impact inflammation and oxygen free radical levels in cerebral ischemia/reperfusion injury. Statins have been shown to reduce morbidity in patients who did not have high serum cholesterol or cardiovascular disease but did have evidence of systemic inflammation. Statins have strong efficacy on modulation of inflammatory responses. conditions where statins have been found to have a positive effect on disease progression or mortality are primarily dependent on leucocyte accumulation. Statins may thus promote the timely resolution of the inflammatory response, preventing persistence of inflammation and resultant pathology. Magnetic resonance spectroscopy (MRS) allows for measurement of metabolites that are undetectable by conventional neuroimaging thereby holding potential to identify traumatic brain injury patients that could benefit from specific neuropsychiatric and cognitive rehabilitation . Brain energy metabolism is altered after TBI due to posttraumatic inflammation and ischemia with mitochondrial dysfunction and loss of neuronal integrity with increased cell membrane turnover. MRS is an MRI technique that can detect nuclei with spins such as 1H, an abundant by-product of cellular respiration and brain tissue metabolites. As a noninvasive and safe technique, MRS is available on clinical MR scanners (1.5 and 3.0 T) without ionizing radiation [15]. This method holds the potential to identify compromised brain metabolism, but evidence after traumatic brain injury is rare .


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date June 1, 2022
Est. primary completion date April 30, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 40 Years
Eligibility Inclusion Criteria: - adult - traumatic brain injury mild to moderate Exclusion Criteria: - immunotherapey - diabetic - previous CNs dysfunction

Study Design


Intervention

Drug:
Atorvastatin
will receive 40 mg atrorvastatin 2 days
Other:
placebo
will receive 40 mg placebo 2 days

Locations

Country Name City State
Egypt Emad Zarief Kamel Said Assiut

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary brain magnetic resonance spectroscopy presence or absence of abnormal metabolites seen by magnetic resonance spectroscopy first 48 hours
Secondary ICU stay days of ICU stay first 30 days
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