Qiu 2007.

Methods	Randomized controlled trial, parallel group
Participants	Total number of participants: 80 Baseline characteristics: Therapeutic cooling Age: mean 41.3 years Gender M/F: 25/15 GCS on admission: number of participants < 6 on GCS = 24 Type of injury (closed/open): closed (non‐penetrating). All participants had craniotomies No cooling Age: mean 40.2 years Gender M/F: 27/13 GCS on admission: number of participants < 6 on GCS = 23 Type of injury (closed/open): closed (non‐penetrating). All participants had craniotomies Inclusion criteria: history of traumatic brain injury, GCS scores ≤ 8, brain injury confirmed by sequential CT scanning within 6 hours after trauma Exclusion criteria: pregnant women, patients < 19 or > 65 years of age, patients with multiple injuries, haemorrhagic shock, or without any brain stem reflex on initial examination, previous disabling neurologic disease Country: China Setting: neurological ICU in brain centre
Interventions	Therapeutic cooling Number of participants: 40 Method of cooling method: water‐circulating cooling blanket, cooling cap. For those who failed to achieve target temperature successfully within 2 hours, refrigerated ice bags were placed around the groin and neck Target temperature: brain temperature was maintained between 33 to 35 °C, and the rectal temperature between 34.5 to 36 °C Time of cooling: directly after craniotomy Duration of cooling: over 4 days Rewarming details: spontaneously return to baseline during a period of 10 to 24 hours Site of measurement: brain and rectal No cooling Number of participants: 40 Method of temperature management: routine pharmacologic or physical measures were applied to maintain body temperature ≤ 37.5 °C Target temperature: brain temperature of 36.5 to 37.5 °C, rectal temperature of 37.5 to 38 °C.
Outcomes	Outcomes measured in study: ICP, serum superoxide dismutase level, favourable neurologic outcome 1 year after injury, mortality at 1 year post injury
Notes	Funding/declarations of interest: grant from Health Bureau of Hangzhou, Zheijang Province Study dates: January 2002 to December 2003
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	"Patient was assigned to one of the following 2 groups in the neurologic intensive care unit of our brain center by using a randomisation table"
Allocation concealment (selection bias)	Low risk	"Allocation and randomisation was concealed so that the study investigators were not aware to which group the patient would be assigned, and the allocation sequence was protected until assignment." No details on methods of concealment; sufficient information to suggest that an adequate method was used.
Blinding of participants and personnel (performance bias): mortality	Low risk	Lack of blinding unlikely to influence performance for this outcome
Blinding of participants and personnel (performance bias): GOS	Unclear risk	Unclear if lack of blinding would influence performance for this outcome
Blinding of outcome assessment (detection bias): mortality; pneumonia	Low risk	No details; lack of outcome assessor blinding is unlikely to influence outcome data
Blinding of outcome assessment (detection bias): GOS	Unclear risk	No details
Incomplete outcome data (attrition bias) All outcomes	Low risk	No apparent losses
Selective reporting (reporting bias)	Unclear risk	Clinical trials registration or pre‐published protocol not reported. Insufficient information to make judgement
Other bias	Low risk	No other sources of bias identified