title: Prospective randomized evaluation of therapeutic decompressive craniectomy in severe traumatic brain injury with mass lesions (PRECIS): study protocol for a controlled trial.
abstract: BACKGROUND
  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. 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.
  
  
  METHODS
  PRECIS 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.
  
  
  CONCLUSIONS
  This study will provide evidence to optimize primary decompressive craniectomy application and assess outcomes and risks for mass lesions in severe traumatic brain injury.
  
  
  BACKGROUND
  ISRCTN20139421.
authors.affiliation: Department of Neurosurgery, West China Hospital, Sichuan University, No. 37 Guoxue Xiang, Chengdu, Sichuan, 610041, P. R. China. ralph-young@hotmail.com.
authors.forename: He-xiang
authors.initials: HX
authors.lastname: Zhao
authors.affiliation: Department of Neuro-intensive care unit, West China Hospital, Sichuan University, No. 37 Guoxue Xiang, Chengdu, Sichuan, 610041, P. R. China. batisky@yeah.net.
authors.forename: Yi
authors.initials: Y
authors.lastname: Liao
authors.affiliation: Department of Neurosurgery, West China Hospital, Sichuan University, No. 37 Guoxue Xiang, Chengdu, Sichuan, 610041, P. R. China. williamding.china@gmail.com.
authors.forename: Ding
authors.initials: D
authors.lastname: Xu
authors.affiliation: Department of Neurosurgery, West China Hospital, Sichuan University, No. 37 Guoxue Xiang, Chengdu, Sichuan, 610041, P. R. China. kouxiangtang7595@163.com.
authors.forename: Qiang-ping
authors.initials: QP
authors.lastname: Wang
authors.affiliation: Department of Neurosurgery, West China Hospital, Sichuan University, No. 37 Guoxue Xiang, Chengdu, Sichuan, 610041, P. R. China. backinblack77@163.com.
authors.forename: Qi
authors.initials: Q
authors.lastname: Gan
authors.affiliation: Department of Neurosurgery, West China Hospital, Sichuan University, No. 37 Guoxue Xiang, Chengdu, Sichuan, 610041, P. R. China. Youchao@vip.126.com.
authors.forename: Chao
authors.initials: C
authors.lastname: You
authors.affiliation: Department of Neurosurgery, West China Hospital, Sichuan University, No. 37 Guoxue Xiang, Chengdu, Sichuan, 610041, P. R. China. PRECISCD120@hotmail.com.
authors.forename: Chao-hua
authors.initials: CH
authors.lastname: Yang
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D001930:Brain Injuries / Q000473:pathology / Q000601:surgery*; D002985:Clinical Protocols; D056424:Decompressive Craniectomy / Q000379:methods*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D017063:Outcome Assessment, Health Care / Q000379:methods*; D016032:Randomized Controlled Trials as Topic / Q000379:methods*; D012107:Research Design; D012720:Severity of Illness Index; D055815:Young Adult