Magazine article Clinical Psychiatry News

Brain Trauma Trials May Finally Be Paying Off

Magazine article Clinical Psychiatry News

Brain Trauma Trials May Finally Be Paying Off

Article excerpt

HONOLULU -- Disappointing clinical trial results should not suggest that outcomes cannot be improved in traumatic brain injury, only that methodologies may need to be refined and study populations equalized as promising approaches come to the fore, Dr. D. James Cooper said during a plenary address at the annual congress of the Society of Critical Care Medicine.

To be sure, meaningful advances have been elusive, with various interventions producing hopeful improvements in animal models, then fizzling in human trials.

But the heterogeneity of the traumatic brain injury (TBI) population and "huge differences" in the specific trauma suffered may make study results look unfairly pessimistic, said Dr. Cooper, deputy director of the intensive care unit at Alfred Hospital, Melbourne.

Experimental treatments may be initiated too late, often because of logistical and informed-consent dilemmas, and older patients may be so unlikely to benefit that they negatively skew results.

Follow-up assessment periods may be too brief, because it increasingly appears that Glasgow Outcome Scale scores improve greatly over time, but at a very slow pace, he said.

A number of lessons have indeed been learned, even from negative clinical trials, and several promising approaches are currently under review.

Serious doubt has been cast on the efficacy of early high-dose steroids, for example, following the curtailment of the 10,000-patient randomized controlled MRC-CRASH (Corticosteroid Randomisation After Significant Head Injury) trial in the United Kingdom after excess deaths were reported in the steroid arm.

"It seems clear from the study that the use of an agent that has been very widely used, particularly in the developing world, clearly and unambiguously increases mortality, accounting for an absolute number of 3% excess deaths. I think it's abundantly clear ... [that the] use of high-dose steroids should cease," said Dr. Cooper, who also serves as associate director for Australia's National Trauma Research Institute.

Because they lower vasopressor requirements in TBI patients, lower-dose steroids are used quite commonly in the intensive care environment, he noted.

"There are no randomized controlled trials at all in this area, and it's clear to me, [based on the unequivocal MRC-CRASH results, that] there needs to be ... a reevaluation" of this practice, said Dr. …

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