E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patient who are going to be under cerebral parenchyma resection, due to epilepsy or tumor |
pacientes sometidos a resección de parénquima cerebral debido a tumor o epilepsia |
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E.1.1.1 | Medical condition in easily understood language |
Patient who are going to be under cerebral parenchyma resection, due to epilepsy or tumor |
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E.1.1.2 | Therapeutic area | Diseases [C] - Nervous System Diseases [C10] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | HLGT |
E.1.2 | Classification code | 10039911 |
E.1.2 | Term | Seizures (incl subtypes) |
E.1.2 | System Organ Class | 10029205 - Nervous system disorders |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10006153 |
E.1.2 | Term | Brain tumor |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Determine the relationship between Magnesium Sulphate administration and levels of S100B protein in serum of patiens undergoing supratentorial brain parenquimal resection |
Determinar la relación entre la administración de sulfato de magnesio y los niveles de proteína S100, subunidad B, en suero, en pacientes sometidos a cirugía de resección de parénquima cerebral supratentorial. |
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E.2.2 | Secondary objectives of the trial |
Determine the relationship between Magnesium Sulphate administration and levels of S100B protein and Specific Neuronal Enolase (SNE) at different points of the postoperative course. Determine the relationship between Magnesium Sulphate administration and improvement on Magnetic Resonance Imaging at early postoperative moment and 6 months after surgery, related to preoperative imaging. Determine the relationship between Magnesium Sulphate administration and improvement on Neuropsychological Assessment at early postoperative moment and 1, 6 and 12 months after surgery. Determine the relationship between Magnesium Sulphate administration and Glasgow Outcome Scale (GOS) and Mortality at 6 and 12 months after surgery. Determine how Apolipoprotein E genotype affects neurological outcome |
Determinar la relación entre la administración de sulfato de magnesio y los niveles de proteína S100, subunidad B, y Enolasa Neuronal Específica en suero en diferentes momentos del postoperatorio. Determinar la relación entre la administración de sulfato de magnesio y la mejoría en algunos parámetros de la resonancia magnética comparando preoperatoria, con una adquisición postoperatoria precoz, y otra a los 6 meses. Determinar la relación entre la administración de sulfato de magnesio y la mejoría en una batería de test neuropsicológicos, preoperatoria, al mes, 6 y 12 meses de la cirugía. Determinar la relación entre la administración de sulfato de magnesio y el GOS y la mortalidad a los 6 y 12 meses. Determinar como el genotipo de la Apolipoproteína E afecta al pronóstico neurológico. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Male and females older than 18 years. -Undergoing supratentorial parenchyma resection surgery. -Capable of collaborate on probes and explorations included in the study. -Signature the written informed consent form. |
- Pacientes de ambos sexos mayores de 18 años. - Intervenido en el hospital Clínic para cirugía de resección de parénquima cerebral - Capaz de someterse a las pruebas y exploraciones que requiere el estudio. -Otorga su Consentimiento Informado por escrito tras ser informado. |
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E.4 | Principal exclusion criteria |
- Life expectancy less than 12 months due to the suspected histological type of tumour. - Hypothalamic-pituitary axis illness. - Presence of Melanoma previously. - Glomerular filtration rate less than 60 mL/min. - Thyroid or parathyroid glands pathology. - Myasthenia gravis. - Respiratory depression. - Pregnancy or breastfeeding. |
- Pacientes con una esperanza de vida inferior a 12 meses debido al tipo histológico sospechado del tumor. - Pacientes con enfermedades del eje hipotálamo-hipofisario. - Pacientes con antecedentes de melanoma. - Pacientes con un filtrado glomerular por debajo de 60 mL/min. - Paciente con patología de tiroides o paratiroides. - Miastenia gravis. - Insuficiencia respiratoria. - Embarazo o lactancia |
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E.5 End points |
E.5.1 | Primary end point(s) |
Serum S100B protein level?s of patients undergoing supratentorial brain parenquimal resection |
Niveles de proteína S100, subunidad B, en suero, en pacientes sometidos a cirugía de resección de parénquima cerebral supratentorial. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
2 hours after the end of the surgery |
A las 2 horas de finalizar la cirugía. |
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E.5.2 | Secondary end point(s) |
Levels of S100B protein and Specific Neuronal Enolase (SNE). Improvement on Magnetic Resonance Imaging. improvement on Neuropsychological Assessment. Glasgow Outcome Scale (GOS) and Mortality. Apolipoprotein E genotype. |
Niveles de proteína S100, subunidad B, y Enolasa Neuronal Específica en suero. Determinados parámetros de la resonancia magnética. Batería de test neuropsicológicos. GOS y la mortalidad. Genotipo de la Apolipoproteína E. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
It depends on the type of end point: S100B protein: pre-surgery; daily postoperative until day 10. SNE: pre-surgery; 2 hours after end of surgery; every 48 hours until day 10. RMI: pre-surgery; early postoperative; 6 months postoperative. Neuropsichologycal assessment: pre-surgery; early postoperative; 1, 6 and 12 months postoperative. GOS: 6 and 12 month postoperative. Mortality: 6 and 12 month postoperative. Apolipoprotein E genotype: pre-surgery. |
Depende del end point: S100B: preoperatoria; diariamente tras la cirugía hasta completar 10 días. SNE: preoperatoria; a las 2 horas de finalizar la cirugía; cada 48 horas hasta completar 10 días. RMI: preoperatoria; postoperatoria precoz (antes del día 5); a los 6 meses de las cirugía. Test neuropsicológicos: preoperatorio; postoperatorio precoz; a mes, 6 y 12 mese de la cirugía GOS: a los 6 y 12 meses de la cirugía. Mortalidad: a los 6 y 12 meses de la cirugía. Genotipo de la Apolipoproteína E: preoperatorio. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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Last visit of las pacient included |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |