Intractable high intracranial pressures (ICP) are associated with poor functional outcomes and mortality, so the SCALPEL trials aims to evaluate the effect of decompressive craniectomy against decompressive laparotomy to lower those pressures in diffuse TBI. The primary outcome measure for that evaluation is functional outcome after 12 months on the extended Glasgow Outcome Scale (GOS-E).
Age between 18 and 65 years
Traumatic Brain Injury with abnormal CT scan
Invasive ICP monitoring in place
ICP >25 mmHg for 1-12h after conventional therapies step I and step II (see Trial flow chart)
Bilateral fixed and dilated pupil
Limitation of therapies by the team due to poor prognosis
Withdrawal of consent
Severe pre-existing physical or mental disability or co-morbidity which would lead to a poor outcome even if the patient made a full recovery from the head injury
Technical University of Munich
Lead sponsor
Federal Ministry of Defence (Germany)
Collaborator
Bundesministerium der Verteidigung
Collaborator