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The effect of controlled decompression for severe traumatic brain injury:A randomized,single-blind,controlled trial

Junhui Chen  Likun Yang  Lei Chen  Weiliang Chen  Chunlei Zhang  Jie Zhu  Yi Feng  Yuhai Wang  
【摘要】:Background Experimental evidence has indicated benefits of controlled decompression for the treatment of severe traumatic brain injury(sTBI).Rapid direct decompression(conventional decompression)for the treatment of sTBI may result in intra-and post-operative complications.Controlled decompression may reduce these complications.Previous clinical trials in China have not yielded conclusive results regarding controlled decompression in sTBI.Therefore,we explored whether controlled decompression treatment decreases the rates of complications as well as improves the outcomes of patients with sTBI.Methods We performed this randomized,single-blinded,controlled trial in our hospital.Patients with sTBI aged 18 to 75 years old need decompressive craniectomy and an indication for decompressive surgery were randomly divided into controlled decompression surgery(n=124)or rapid direct decompression surgery(n=124).The primary outcome measures were the Glasgow Outcome Scale(GOS)score at 3 months and 30-day all-cause mortality.The secondary outcome was the incidence of intraoperative brain swelling/acute encephalitis,post traumatic cerebral infarction and delayed haematoma.This study was registered with the Chinese Clinical Trial Registry,www.chictr.org.cn,number ChiCTR-TCC-13004002.Results Compared with the conventional decompression group,the controlled decompression group showed a non-significant trend to lower 30-day all-cause mortality(24.8% vs 33.6%,P=0.148)and improved 3-month recovery(30.1% vs 21.5%).In addition,patients in the controlled decompression group had a lower intraoperative brain swelling/acute encephalitis rate(13.3% vs 24.3%,P=0.036),a lower delayed haematoma rate(17.7% vs 29.0%,P=0.048)and a relatively lower post-traumatic cerebral infarction rate(15.0% vs 22.4%,P=0.127)than those in the conventional decompression group.Conclusions Our data show that controlled decompression surgery significantly reduces procedure-related complications compared to conventional craniectomy and suggests that outcomes are better.However,this was a single-hospital study.Well-designed,multicentre,randomized controlled trials are needed to confirm clinical benefits.

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