3.3. Ethical considerations, information giving and written informed consent

Ethics approval of the coordinating centre was obtained from Comité de Ética de la Investigación de las Islas Baleares (CI-IB:10/19, eudraCT: 2019–004038–41) and from Comité de Ética de la investigación from the Hospital Universitario 12 de Octubre. The trial has also been approved by the Agencia Española del Medicamento y Productos Sanitarios (AEMPS), which is a public agency depending on the Health Ministry of the Spanish Government.

The GCS score is a method of assessing the level of consciousness in TBI patients. Patients with a GCS score of 15 are generally considered fully conscious, but those with a GCS score of 14 or less may not be fully conscious and would not be mentally capable of giving informed consent to participation in a clinical trial. Besides, a brain contusion is a clinical sign indicating significant brain injury, and patients with this diagnosis would not be physically or mentally capable of giving informed consent to participation in a clinical trial.

Therefore, given that patients are eligible for inclusión in the DEXCON TBI trial if they have TBI with a brain contusion on a CT scan, in most cases they will, by default, be physically or mentally incapable of giving consent.