Rationale, methodology, and implementation of a nationwide multicenter randomized controlled trial of long-term mild hypothermia for severe traumatic brain injury (the LTH-1 trial)》.pdf

Contemporary Clinical Trials 40 (2015) 9–14 Contents lists available at ScienceDirect Contemporary Clinical Trials journal homepage: /locate/concli nt rial Rationale, methodology, and implementation of a nationwide multicenter randomized controlled trial of long-term mild hypothermia for severe traumatic brain injury (the LTH-1 trial) Jin Lei 1, Guoyi Gao 1, Qing Mao, Junfeng Feng, Lei Wang, Wendong You, Jiyao Jiang ⁎, the LTH-1 trial collaborators Shanghai Institute of Head Trauma, Shanghai, Peoples Republic of China Department of Neurosurgery, Renji Hospital, Shanghai Jiaotong University School of Medicine, 1630 Dongfang Road, Shanghai 200127, Peoples Republic of China a r t i c l e i n f o a b s t r a c t Article history: Background: Traumatic brain injury (TBI) is a major public health problem recently, however, no Received 15 September 2014 intervention showing convincing efficacy. Therapeutic hypothermia with a relatively long Received in revised form 2 November 2014 duration (more than 48 h), as a promising treatment measure, might improve the patient Accepted 5 November 2014 outcome following severe TBI. Available online 12 November 2014 Methods/design: The LTH-1 trial is a prospective, nationwide multicenter, randomized, controlled clinical trial to examine the efficacy and safety of long-term mild hypothermia in adult patients Keywords: after severe traumatic brain injury. A total of 300 consecutive patients will be recruited