Abstract
BackgroundFor cases of severe traumatic brain injury, during primary operation, neurosurgeons usually face a dilemma of whether or not to remove the bone flap after mass lesion evacuation. Decompressive craniectomy, which involves expansion of fixed cranial cavity, is used to treat intra-operative brain swelling and post-operative malignant intracranial hypertension. However, due to indefinite indication, the decision to perform this procedure heavily relies on personal experiences. In addition, decompressive craniectomy is associated with various complications, and the procedure lacks strong evidence of better outcomes. In the present study, we designed a prospective, randomized, controlled trial to clarify the effect of decompressive craniectomy in severe traumatic brain injury patients with mass lesions.MethodsPRECIS is a prospective, randomized, assessor-blind, single center clinical trial. In this trial, 336 patients with traumatic mass lesions will be randomly allocated to a therapeutic decompressive craniectomy group or a prophylactic decompressive craniectomy group. In the therapeutic decompressive craniectomy group, the bone flap will be removed or replaced depending on the emergence of brain swelling. In the prophylactic decompressive craniectomy group, the bone flap will be removed after mass lesion evacuation. A stepwise management of intracranial pressure will be provided according to the Brain Trauma Foundation guidelines. Salvage decompressive craniectomy will be performed for craniotomy patients once there is evidence of imaging deterioration and post-operative malignant intracranial hypertension. Participants will be assessed at 1, 6 and 12 months after randomization. The primary endpoint is favorable outcome according to the Extended Glasgow Outcome Score (5–8) at 12 months. The secondary endpoints include quality of life measured by EQ-5D, mortality, complications, intracranial pressure and cerebral perfusion pressure control and incidence of salvage craniectomy in craniotomy patients at each investigation time point.DiscussionThis study will provide evidence to optimize primary decompressive craniectomy application and assess outcomes and risks for mass lesions in severe traumatic brain injury.Trial registrationISRCTN20139421
Highlights
For cases of severe traumatic brain injury, during primary operation, neurosurgeons usually face a dilemma of whether or not to remove the bone flap after mass lesion evacuation
We found there might be some predictive values of initial intracranial cerebral pressure (ICP) for the risk of post-operative refractory intracranial hypertension [31]
The bones of contention regarding the use of decompressive craniectomy (DC) for patients with Severe traumatic brain injury (STBI) are the treatment outcome and risk prediction
Summary
Study design PRECIS is a prospective, randomized, assessorblinded, controlled clinical trial designed at the West China Hospital, Sichuan University (Fig. 1). The primary hypothesis Therapeutic DC, which is performed on the basis of emergence of intra-operative brain swelling, results in a better outcome compared with prophylactic DC for STBI patients with mass lesions. The initial data collection will be assessed at the emergency room by an attending physician This collection will include baseline status, torso and/or extremities AIS, trauma severity (GCS, motor score and pupillary reaction), CT parameters (mass lesion type, volume of haematoma and midline-shift), time of injury-to-operation, cause of injury and initial laboratory features (arterial blood gas parameters, coagulation and platelet count). Further secondary endpoints include mortality and complications at corresponding time point, ICP and CPP control and incidence of salvage DC in craniotomy patients. Trial management team The responsibilities of TMT include trial conception, intervention design, patient safety, quality assurance, data analysis and writing. CSG will perform the online random allocation system, database establishment and maintenance
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