Rationale, methodology, and implementation of a nationwide multicenter randomized controlled trial of long-term mild XXXX for severe @entity131 (the LTH-1 trial).

@entity1 @entity131 @entity772 @entity2332
BACKGROUND: @entity131 ( @entity131 ) is a major public health problem recently, however, no intervention showing convincing efficacy. @entity2332 with a relatively long duration (more than 48h), as a promising treatment measure, might improve the @entity1 outcome following severe @entity131 . 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 @entity2332 in adult @entity1 after severe @entity131 . A total of 300 consecutive @entity1 will be recruited from 15 large neurosurgical centers in China. The eligible @entity1 will be randomized to receive either long-term mild @entity2332 (34-35  C) for 5days, or normothermia (36-37  C). Additionally, a standardized management protocol will be used in all @entity1 . The primary end point is the neurological outcome 6months post-injury on the Glasgow Outcome Scale. The secondary outcomes include GOS score at one month post-injury, mortality during six months after injury, length of ICU and hospital stay, intracranial pressure control and Glasgow @entity772 Scale score during the hospital stay and frequency of complications during the six-month follow-up period. DISCUSSION: Long-term @entity2332 is recommended by most recent studies and its efficacy urgently needs to be established in randomized controlled settings. The LTH-1 trial, together with other ongoing studies, will present more evidence for optimal use of @entity2332 in severe @entity131 @entity1 .
