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. 2016 Aug 15;33(16):1461–1478. doi: 10.1089/neu.2015.4233

Table 3.

Summary of Robust (Multi-Center, Low Risk of Bias, n > 100) Acute TBI RCTs (Multiple RCTs for an Intervention Highlighted)

Study Characteristics Study findings Risk of bias    
Study Country (N countries) Number (Number of centers >1) Comparison GCS (mean): Md = Median, R = Range) Mortality: early (≤1 month) Mortality: late (> 1 month) Mortality: NR ICP* Length of stay: ICU Length of stay: hosp. GOS (E = GOSE)** 6 month unless stated Random seq. Allocation concealment Covariate adjustment Ordinal approach
Fluid management [1]
Myburgh 2007 2 460 (16) Saline vs. albumin 7 (Md) S S         S (E, 24) L L Y N
Hypothermia [1]
Andrews 2015 18 387 (47) Hypothermia vs. normothermia 3 – 15 (R)   I   ND ND   I (E) L L Y Y
Management guided by ICP [1]
Chesnut 2012 2 324 (6) ICP-guided Mx vs. clinical-imaging guided Mx 3 – 8 (R)   ND     ND   ND (E) L U Y Y
Pharmacological therapies not elsewhere defined [13]
Skolnick 2014 21 1195 (140) Progesterone vs. placebo 3 – 8 (R)   ND         ND, ND (E) L L Y Y
Wright 2014 USA 882 (49) Progesterone vs. placebo 4 – 12 (R)   ND         ND (E) L L Y Y
Shakur 2009 8 228 (15) Low-, medium-, or high-dose Anatibant vs. placebo 7·5 / 7·6 ND             L L Y  
Marmarou 1999 USA 139 (31) Bradycor vs. placebo 6·0 / 6·1   ND   ND     ND L L Y N
Euro. Study Group 1994 13 852 (21) Nimodipine vs. placebo NR   ND         ND U L Y N
Teasdale 1992 3 352 (7) Nimodipine vs. placebo NR   ND   ND     ND U L N N
Perel 2012 2 170 (10) Tranexamic acid vs. placebo 10·5 / 10·5 ND             U L Y  
Robertson 2014 USA 200 (2) Erythropoetin vs. placebo NR   ND         ND U L L  
Maas 2006 15 861 (15) Dexanabinol vs. placebo NR   ND   ND     ND L L L  
Yurkewicz 2005 USA 404 (40) Traxopodil vs. placebo 4 – 8 (R)   ND         ND L U L  
Morris 1999 6 693 (99) Selfotel vs. control [ceased; mortality / adverse events] 6·1 / 6·1   ND         ND U L L  
Marshall 1998 15 1120 (15) Tirilazad vs. placebo 4 – 12 (R)   ND         ND L U L  
Young 1996 USA 463 (29) High-dose pegorgotein vs. placebo 5·6 / 5·3   ND         ND U L L  
      Low-dose pegorgotein vs. placebo 5·5 / 5·3   ND         ND        
Pre-hospital cazre [3]
Bernard 2010 Australia 312 (4) RSI vs non-invasive ventilation 5·0 ND ND     ND ND S (E) L L N N
Morrison 2011 Canada 113 (2) HTS + dextran vs. normal saline ≤ 8 ND         ND ND (E, 4) U L N N
Bulger 2010 2 1331 (11) HTS + dextran vs. HTS vs. normal saline 4·9 / 5·0 / 5·0 ND     ND ND ND ND L L N N
Seizure Prophylaxis [1]
McQueen 1983 UK 164 (2) Phenytoin vs. placebo NR   ND           U L N  
Steroids [3]
Asehnoune 2014 France 336 (19) Hydrocortisone + fludrocortisone vs. placebo ≤ 8 ND ND     ND     L L Y  
Edwards 2005 49 10,008 (239) Methylprednisolone vs. placebo 3 – 14 (R)   I         ND U L N N
Grumme 1995 2 396 (9) Triamcinolone vs. placebo Most <8 ND ND         ND (12) U L N N
Surgery [3]
Jiang 2005 China 486 (5) Standard large craniectomy vs. limited craniectomy 5·2 / 5·3   S   S     S L L N N
Mendelow 2015 13 170 (31) Early surgery (hematoma) vs. standard care <8 – 15 (R)   S         ND, ND (E) L H Y N
Cooper 2011 3 155 (15) DC vs. standard care 5 / 6 (Md)   ND   S S ND I L L Y Y
*

There is variability in how RCTs measure and report intracranial pressure (ICP). For this table, statistical significance was judged according to the overall ICP results as reported

**

GOS (Glasgow Outcome Scale)/GOSE (Glasgow Outcome Scale-Extended) = proportion of favorable outcome (e.g., GOS 4 or 5) between groups unless otherwise stated.

DC, decompressive craniectomy; Random Seq., random sequence generation; H, high risk of bias; Hosp., hospital; HTS, hypertonic saline; ICU, intensive care unit; I, intervention inferior (statistically significant difference favoring control, non-bold in comparison column); L, low; Mx, management; N, no; ND, no statistically significant difference between groups; NR, not reported; RSI, rapid sequence intubation; S, intervention superior (statistically significant difference favoring intervention, bold in comparison column); SA, South Africa; U, unclear; UK, United Kingdom; USA, United States of America; Y, yes.