title: Minimally invasive surgery treatment for the patients with spontaneous supratentorial intracerebral hemorrhage (MISTICH): protocol of a multi-center randomized controlled trial.
abstract: BACKGROUND
  The choice of surgical or conservative treatment for patients with spontaneous intracerebral hemorrhage is controversial. Some minimally invasive treatments have been applied to hematoma evacuation and could improve prognosis to some extent. Up to now, studies on minimally invasive surgery for patients with spontaneous intracerebral hemorrhage are still insufficient.
  
  
  METHODS
  The MISTICH is a multi-center, prospective, randomized, assessor-blinded, parallel group, controlled clinical trial. 2448 eligible patients will be assigned to neuroendoscopy group, stereotactic aspiration group and craniotomy group randomly. Patients will receive the corresponding surgery based on the result of randomization. Surgeries will be performed by well-trained surgeons and standard medical treatment will be given to all patients. Patients will be followed up at 7 days, 30 days, and 6 months. The primary outcome of this study is unfavorable outcome at 6 months. Secondary outcomes include: mortality at 30 days and 6 months after surgery; neurological functional status of 6 months after surgery; complications including rebleeding, ischemic stroke and intracranial infection; days of hospitalization.
  
  
  CONCLUSIONS
  The MISTICH trial is a randomized controlled trial designed to determine whether minimally invasive surgeries could improve the prognosis for patients with spontaneous intracerebral hemorrhage compared with craniotomy. (ChiCTR-TRC-12002026. Registered 23 March 2012).
authors.forename: Jun
authors.initials: J
authors.lastname: Zheng
authors.forename: Hao
authors.initials: H
authors.lastname: Li
authors.forename: Rui
authors.initials: R
authors.lastname: Guo
authors.forename: Sen
authors.initials: S
authors.lastname: Lin
authors.forename: Xin
authors.initials: X
authors.lastname: Hu
authors.forename: Wei
authors.initials: W
authors.lastname: Dong
authors.forename: Lu
authors.initials: L
authors.lastname: Ma
authors.forename: Yuan
authors.initials: Y
authors.lastname: Fang
authors.forename: Anqi
authors.initials: A
authors.lastname: Xiao
authors.forename: Ming
authors.initials: M
authors.lastname: Liu
authors.affiliation: Department of Neurosurgery, West China Hospital, Sichuan University, Chengdu 610041, Sichuan, China. ns_youchao@126.com.
authors.forename: Chao
authors.initials: C
authors.lastname: You
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002543:Cerebral Hemorrhage / Q000601:surgery*; D002985:Clinical Protocols; D003399:Craniotomy / Q000379:methods*; D006801:Humans; D008875:Middle Aged; D019060:Minimally Invasive Surgical Procedures / Q000379:methods*; D015337:Multicenter Studies as Topic; D044583:Neuroendoscopy / Q000379:methods*; D017063:Outcome Assessment, Health Care