E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Pacientes con traumatismo severo y acidosis láctica por shock hemorrágico.//Severely injured trauma patients with lactic acidosis due to hemorrhagic shock. |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10050841 |
E.1.2 | Term | Hemorrhagic shock |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10023676 |
E.1.2 | Term | Lactic acidosis |
|
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 |
El objetivo principal es evaluar la seguridad y la eficacia de un tratamiento con 250 ml de MP4OX en comparación con 250 ml de solución salina isotónica más dosis de reposición si continúa la hemorragia, añadido al tratamiento habitual, en pacientes con traumatismo severo y acidosis láctica por shock hemorrágico. // The primary objective is to evaluate the safety and efficacy of 250 mL MP4OX treatment compared to 250 mL of normal saline solution plus replacement doses if continued hemorrhage, in addition to standard treatment, in severely injured trauma patients with lactic acidosis due to hemorrhagic shock. |
|
E.2.2 | Secondary objectives of the trial |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1) Obtención del consentimiento informado antes de ninguna actividad relacionada con el estudio 2) Traumatismo (contuso y/o penetrante) que dé lugar a acidosis láctica por shock hemorrágico 3) Acidosis (nivel de lactato sanguíneo >o= 5 mmol/L; equivalente a 45 mg/dl), arterial o venosa 1) Informed consent obtained before any study-related activities (study-related activities are any procedure that would not have been performed as standard of care for the patient) 2) Trauma injury (blunt and/or penetrating) resulting in lactic acidosis due to hemorrhagic shock 3) Acidosis (blood lactate level >o= 5 mmol/L; equivalent to 45 mg/dL) arterial or venous. |
|
E.4 | Principal exclusion criteria |
1) Lesión masiva incompatible con la vida 2) Normalización del lactato antes del tratamiento (<o= 2,2 mmol/L) 3) Pacientes con signos de lesión cerebral traumática grave definida por CUALQUIERA de los siguientes criterios: a) Traumatismo craneoencefálico o lesión cerebral abierta incompatibles con la vida conocidos b) Puntuación de la GCS (conocida de la AIS (escala abreviada de lesiones; región de la cabeza) >o= 4 en examen mediante métodos adecuados de diagnóstico por imagen d) Posible cirugía de SNC e) Hallazgos en la exploración física indicativos de lesión grave en el SNC o la médula espinal por encima de D5 4) Parada cardiaca antes de la aleatorización 5) Edad inferior a la edad legal de consentimiento 6) Tiempo estimado entre el traumatismo y la aleatorización > 4 horas 7) Tiempo estimado entre el ingreso hospitalario y la aleatorización > 2 horas 8) Embarazo conocido 9) Uso de cualquier transportador de oxígeno distinto de hematíes 10) Participación previa conocida en este estudio 11) Profesional o personal auxiliar involucrado en este estudio 12) Recepción conocida de cualquier medicamento en investigación en el plazo de los 30 días anteriores al estudio // 1)Massive injury incompatible with life 2)Normalization of lactate prior to dosing (<o= 2.2mmol/L) 3)Patients with evidence of severe traumatic brain injury as defined by ANY one of the following: a)Known non-survivable head injury or open brain injury b)Glasgow Coma Score (GCS) = 3, 4 or 5 c)Known AIS (head region) >o= 4 shown by an appropriate imaging methodology d)Contemplated CNS surgery e)Abnormal physical exam indicative of severe CNS or any spinal cord injury above T5 level 4)Cardiac arrest prior to randomization 5)Age below the legal age for consenting 6)Estimated time from injury to randomization> 4 hours 7)Estimated time from hospital admission to randomization > 2 hours 8)Known pregnancy 9)Use of any oxygen carrier other than RBCs 10)Known previous participation in this study 11)Professional or ancillary personnel involved with this study 12)Known receipt of any investigational drug(s) within 30 days prior to study. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
El criterio de valoración principal de la eficacia es la proporción de pacientes dados de alta del hospital hasta el día 28 y que permanezcan con vida en la visita de seguimiento del día 28. // The primary efficacy endpoint is the proportion of patients discharged from hospital through day 28 and alive at the Day 28 Follow up visit. |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
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 | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
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) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 34 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
|
E.8.7 | Trial has a data monitoring committee | Yes |
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
|
Ultima visita del último sujeto en el ensayo.// Last visit of the last subject undergoing the trial. |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |