Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 11:41 PM
Ignite Modification Date:
2025-12-24 @ 11:41 PM
NCT ID:
NCT03818451
Brief Summary:
Traumatic brain injury (TBI) typically provokes secondary injury mechanisms, including the dynamic interplay between the ischemic, inflammatory, and cytotoxic processes. Moreover, such an impact induces a substantial level of cell death and results in the degeneration of the dendrites, thereby leading to persistent motor, sensory, and cognitive dysfunction. Previous studies have shown that the adult-born immature granule neurons in the dentate gyrus are the most susceptible of all the cell types in the hippocampus to damage following a moderate TBI due to a controlled cortical impact (CCI) device. Currently, there is no efficient approach available for avoiding immature neuron death or degeneration following TBI. Hence, this study aimed to assess the neuro-regenerative properties of co-ultramicronized PEALut (Glialia®), which is composed of palmitoylethanolamide (PEA) and the flavonoid luteolin (Lut), in an in vivo model of TBI, as well as in patients affected by TBI.
Detailed Description:
Study Setting All patients affected by moderate TBI (Glasgow Coma Score 9-13) admitted to the neurosurgical department of the University Hospital of Messina, Italy, will be screened for recruitment.
Ethics The institutional review board (IRB) approved the study. Written consent will be obtained from each patient or the closest family member prior to the start of the study.
Study Design A randomized controlled single-blind study to assess the effects of co-ultraPEALut (Glialia®) administration in TBI patients will be carried out. The study is set to recruit at least 30 patients.
Recruited patients are randomly allocated to one of the two branches of the study: standard TBI treatment + Glialia® (Study Group) and standard TBI treatment (Control Group) in a 1:1 ratio using precompiled randomization tables.
General treatment
All patients will undergo standard treatments according to patterns of severity and in the light of distinct variables, mainly represented by the conditions of cerebral hemodynamics. These procedures can be summarized as follows:
* Surgical evacuation of hemorrhagic masses and / or "debridement" of outbreaks brain contusion;
* Medical management aimed to maintenance of euvolemia and adequate brain perfusion. Goals were a systolic blood pressure \>90 mmHg and a cerebral perfusion pressure \>60 mmHg. Prevention of secondary complications of critical illness included: preventive therapy of venous thromboembolism (VTE) using low molecular weight heparin (LMWH) and seizures using levetiracetam prophylactically for the first seven days after injury;
* Patient who underwent surgical treatment, received also postoperative intensive care treatments including: position of the head high, lower values of end-tidal CO2, sedation with reduced metabolic consumption of O2, increase in plasma osmolarity by administration of mannitol in controlled doses or hypernatremia, therapeutic CSF drainage.
Specific Treatment The investigations agent, the co-ultraPEALut, will be administered orally twice daily (every 12 h) for 180 days in association with the specific therapy (e.g., antiplatelet agents, anticoagulants, antiepileptic drugs) commonly administered to these patients and/or with drugs prescribed for comorbidities (i.e. diabetes, arterial hypertension).
Study:
NCT03818451
Study Brief:
Protocol Section:
NCT03818451