Co-ultra PEALut Enhances Neuronal Recovery Following Moderate Traumatic Brain Injury
Paraules clau
Resum
Descripció
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).
Dates
| Darrera verificació: | 12/31/2018 |
| Primer enviat: | 01/17/2019 |
| Inscripció estimada enviada: | 01/22/2019 |
| Publicat per primera vegada: | 01/27/2019 |
| Última actualització enviada: | 01/24/2019 |
| Publicació de l'última actualització: | 01/28/2019 |
| Data d'inici de l'estudi real: | 04/30/2016 |
| Data estimada de finalització primària: | 10/30/2019 |
| Data estimada de finalització de l’estudi: | 12/30/2019 |
Condició o malaltia
Intervenció / tractament
Dietary Supplement: Study Group
Fase
Grups de braços
| Braç | Intervenció / tractament |
|---|---|
| No Intervention: Control Group All patients are treated by standard treatments according to patterns of severity and in the light of different variables, mainly represented by the conditions of cerebral hemodynamics. These procedures can be summarized as follows:
Surgical evacuation of hemorrhagic masses and brain contusion
Medical management aimed to maintenance of euvolemia and adequate brain perfusion. Prevention of secondary complications of critical illness included: preventive treatment of venous thromboembolism (VTE) and seizures
Patient who undergo surgical treatment, will recieve 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 | |
| Experimental: Study Group Standard treatment plus specific treatment. The investigational agent, the co-ultraPEALut, is 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). | Dietary Supplement: Study Group Co-ultraPEALut is administered to moderate traumatic brain injured patients for 180 days |
Criteris d'elegibilitat
| Edats elegibles per estudiar | 18 Years Per a 18 Years |
| Sexes elegibles per estudiar | All |
| Accepta voluntaris saludables | Sí |
| Criteris | Inclusion Criteria: - Traumatic brain injuries - Moderate trauma - Glasgow Coma Score 9-13 - Loss of consciousness lasting >1 min - post-traumatic amnesia >20 minutes - CT scan Marshall Scale class II-VI. Exclusion Criteria: - Spinal cord injuries - Pre-existing neurological disorders affecting the brain and/or the spinal cord - Severe hypertension - Diabetes, and chronic renal disease - Remarkable chronic cerebravasculopathy of the CT - Severe cognitive deficit. |
Resultat
Mesures de resultats primaris
1. Cognitive outcome assessed Mini Mental State Examination (MMSE) [All patients will undergo neurological and neuropsychological evaluations at baseline (T0), after 30 days (T30) and 6 months (T180)]
2. Cognitive outcome assessed by the Brief Neuropsychological Cognitive Examination (BNCE) [All patients will undergo neurological and neuropsychological evaluations at baseline (T0), after 30 days (T30) and 6 months (T180)]
3. Depression outcome assessed by Beck Depression Inventory [Outcome measure will be assessed at 180 days (T180) after trauma]
4. Assessment of Independence by Barthel Index [Outcome measure will be assessed at 180 days (T180) after trauma]
