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Table 1 Clinical data: baseline characteristics and outcomes of propranolol and clonidine (treatment) versus double placebo after severe traumatic brain injury

From: Effect of propranolol and clonidine after severe traumatic brain injury: a pilot randomized clinical trial

Clinical data

Placebo (n = 26)

Treatment (n = 21)

P value

Baseline characteristics

 Age, in median (IQR)

28 (19–36)

24 (21–34)

 

 Sex, in N (%)

  Female

1 (4)

5 (24)

 

  Male

25 (96)

16 (76)

 

 Race, in N (%)

   

  Black

2 (8)

2 (10)

 

  White

24 (92)

19 (90)

 

 Injury Severity Score (ISS)a, in median (IQR)

41 (30–45)

36 (34–43)

 

 Sequential Organ Failure Assessment (SOFA) Score, in median (IQR)

7 (5–9)

7 (4–9)

 

 Marshall Head CT Classb, in N (%)

  Class II (diffuse injury)

16 (62)

14 (67)

 

  Class III (diffuse injury & swelling)

6 (23)

7 (33)

 

  Class IV (diffuse injury & shift)

3 (11)

0 (0)

 

  Class VI (non-evacuated lesion)

1 (4)

0 (0)

 

Outcomes

 Ventilator-free days, in mean ± SD

18.0 (0.1–20.5)

16.2 (5.5–20.1)

0.88

 ICU length of stay, days, in median (IQR)

11 (6–18)

15 (10–21)

0.14

 Hospital length of stay, days, in median (IQR)

18 (7–25)

20 (14–31)

0.23

 In-hospital mortality, in N (%)

7 (27)

4 (19)

0.73

 CFSc during treatment

9.5 (8.0–11.0)

8.0 (6.0–9.0)

0.01

 Fentanyl dose totald mcg, in mean ± SD

8015 ± 5686

7375 ± 5931

0.71

 Propofol dose totald mcg/kg, in mean ± SD

1314 ± 1068

1377 ± 1382

0.86

 Ranchoe score at discharge

3.5 (2.0–5.0)

5.0 (3.8–5.0)

0.33

 GOSEf at 3 months, in N (%)

  

0.89

  GOSE1

8 (33)

5 (26)

 

  GOSE2

3 (12)

2 (11)

 

  GOSE3

7 (29)

5 (26)

 

  GOSE4

3 (12)

3 (16)

 

  GOSE5

1 (4)

2 (11)

 

  GOSE6

1 (4)

2 (11)

 

  GOSE7

0 (0)

0 (0)

 

  GOSE8

1 (4)

0 (0)

 

 GOSEf at 12 months, in N (%)

  

0.84

  GOSE1

8 (31)

5 (25)

 

  GOSE2

1 (4)

1 (5)

 

  GOSE3

4 (15)

1 (5)

 

  GOSE4

3 (12)

3 (15)

 

  GOSE5

2 (8)

3 (15)

 

  GOSE6

5 (19)

3 (15)

 

  GOSE7

3 (12)

3 (15)

 

  GOSE8

0 (0)

1 (5)

 

 QOLIBRIg at 3 months

69 (52–76)

69 (54–82)

0.75

 QOLIBRIg at 12 months

70 (61–76)

69 (65–76)

0.82

 Trail Making Testh at 3 months

57 (36–159)

100 (53–134)

0.43

 Trail Making Testh at 12 months

62 (51–103)

39 (35–65)

0.04

  1. ICU intensive care unit, SD standard deviation, CI confidence interval
  2. Statistical testing: Pearson test used for categorial outcomes; Wilcoxon test used for continuous outcomes
  3. aInjury Severity Score, ISS, ranges from 1 to 75, major trauma (or polytrauma) is defined as the ISS being greater than 15
  4. bMarshall Head CT Class, CT scan derived metric, that places patients into one of six categories (I to VI) of increasing severity on the basis of findings on non-contrast CT scan of the brain; Marshall Class I, no injury, and Marshall Class V, evacuated mass lesion were exclusions for enrollment
  5. cCFS, paroxysmal sympathetic hyperactivity and clinical features scale (range 0–18, with mild 1–6, moderate 7–12, and severe 13+)
  6. dTotal dose received during hospitalization
  7. eRancho, Rancho Los Amigos Levels of Cognitive Functioning Scale (range 1–10, higher is higher functioning)
  8. fGOSE, Extended Glasgow Outcome Scale (range 1–8, higher is better functional outcome)
  9. gQOLIBRI, Quality of life after Brain Injury scale (range 0–100, higher is better quality of life)
  10. hTrail Making Test Part B
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Critical Care

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