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
Parallel
Decompressive Laparotomy
Procedure/SurgeryAs described in the study protocol a long midline laparotomy is performed and open abdomen therapy using negative pressure dressings initiated to lower abdominal pressure and thereby improve venous return from the brain to lower intracranial pressure.
Decompressive Craniectomy
Procedure/SurgeryAs described in the study protocol a sufficiently sized hemi-craniectomy is performed and the skin closed over the bony defect to allow cerebral swelling and thereby lower intracranial pressure.
Functional outcome measured by the extended Glasgow Outcome Scale (GOS-E)
8 Good recovery Upper no current problems related to the brain injury that affect daily life; 7 Good recovery Lower minor problems that affect daily life; resumes \>50% of the pre-injury level of social and leisure activities; 6 Moderate disability Upper reduced work capacity; resumes \<50% of the pre-injury level of social and leisure activities; 5 Moderate disability Lower unable to work or only in sheltered workshop; 4 Sever disability Upper can be left alone \> 8h during the day, but unable to travel and/or go shopping without assistance; 3 Sever disability Lower requires frequent help of someone to be around at home most of the time every day; 2 Persistent vegetative state unresponsive and speechless; 1 Death \[higher scores mean better outcomes\]
Mortality
Serious adverse events and surgical complications measured by the Clavien-Dindo Scale
Grade I Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic and radiological interventions Allowed therapeutic regimens are: drugs as antiemetics, antipyretics, analgetics, diuretics and electrolytes and physiotherapy. This grade also includes wound infections opened at the bedside. Grade II Requiring pharmacological treatment with drugs other than such allowed for grade I complications. Blood transfusions and total parenteral nutrition are also included. Grade III Requiring surgical, endoscopic or radiological intervention * IIIa Intervention not under general anesthesia * IIIb Intervention under general anesthesia Grade IV Life-threatening complication (including centralnervous complications)\* requiring intensive care management * IVa single organ dysfunction (including dialysis) * IVb multi organ dysfunction Grade V Death of a patient
Frequency and severity of organ failure
EQ-5D life quality
European Quality of Life Questionnaire \[minimum 1, maximum 5, lower scores mean better outcomes\]
Click on the lead sponsor to view all of their trials.
Technical University of Munich
Lead sponsor
Federal Ministry of Defence (Germany)
Collaborator
Bundesministerium der Verteidigung
Collaborator
