Acute Spinal Cord Trauma

Robert L Wears, MD, MS

Practice Guidelines: A Pan-American Symposium

Santiago de Chile7 October 2003

Critical Question

• 20 yr old male fell 5 meters– C4-5 fracture – dislocation– Motor deficit

• Should he be given steroids? – What is the evidence for benefit?– What is the evidence for harm?

Epidemiology

• ~ 40 per million population annually

• Typically– Young (20 – 35)– Male

• Major disability

• Shortened life expectancy

• Major cost

Study Selection

• Randomized or quasi-randomized trials• Patients admitted for acute spinal cord injury

– Exclude nerve root only, cauda equina syndrome

• Outcome measures– Recovery of motor function (6 weeks, 6 months, 1 yr)

(0 – 70 scale | 14 muscles 0-5)

– Mortality

Studies Included

Study Intervention Allocation Assessment NBracken 85 Hi / low dose B B 330

Bracken 90 Hi / naloxone /placebo

B B 487

Otani 94 Hi / none N ? 158

Bracken 98 F/U dosage B B 499

Petijean 98 Hi / nimodipine factorial

N B 77

*Matsumoto 01 Hi / none B N 46

Studies Excluded

Study Allocation Assessment OtherGlasser B N Disc surgery

Petterson B B Whiplash, no motor outcomes

Kiwerski N N Not randomized

Pointillar B B Duplicate (translation) of Petitjean

Efficacy (Overall)

Study Change in motor score6 wks 6 months 1 year

Bracken 90 1.23 -0.01 -0.86

Otani 94 3.90

Petitjean -5.70

Pooled CI -1.1, 3.5 -1.8, 3.5 -4.8, 2.5

Efficacy (< 8 hrs)

Study Change in motor score6 wks 6 months 1 year

Bracken 90 3.47 4.78 5.20

Otani 94 3.90

Petitjean -5.70

Pooled CI* 0.6, 7.6

*pooled at either 6 mo or 1 yr

24 Vs 48 Hours Treatment

Study Placebo Bolus+24h Bolus+48h

NASCIS 1 12.0 (13.4) 17.2 (13.4)

NASCIS 2 13.7 (14.1) 19.0 (19.6)

Mean (SD)

Safety

• Mortality, wound infection, GI bleed– No significant difference– Wide CI

• Mortality RR .24 to 1.25

– Acute trauma studies low powered– Sauerland 2000 systematic review

• 51 trials (including back surgery), > 2000 pts• No significant difference mortality, GI bleed,

infection

Conclusion

• Benefit is modest at best – 5 – 8 points on 70 point scale– Class B

• Minimum clinically important benefit undefined

• Must be given early to be effective• No convincing evidence of harm

– Low power limits safety assessment