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Randomized Controlled Trial Clinical Trial
Neuroprotection during cardiac surgery: a randomised trial of a platelet activating factor antagonist.
- D P Taggart, S M Browne, D T Wade, and P W Halligan.
- Department of Cardiac Surgery, John Radcliffe Hospital, Oxford, UK. david.taggart@orh.anglox.nhs.uk
- Heart. 2003 Aug 1; 89 (8): 897-900.
ObjectiveTo assess platelet activating factor (PAF) antagonists, potent neuroprotective agents in experimental cerebral dysfunction, in clinical practice.DesignDouble blind, minimised, placebo controlled trial of low and high dose PAF antagonist (lexipafant).SettingCardiac surgery unit.Patients150 patients undergoing coronary artery bypass graft (CABG) surgery using cardiopulmonary bypass.InterventionsRandomisation to placebo, low dose (10 mg) or high dose (100 mg) lexipafant.Main Outcome MeasuresIncidence of impairment on four established cognitive tests, undertaken before, five days, and three months after CABG, examined by three methods for defining impairment.ResultsThe three groups were similar with respect to preoperative and intraoperative factors. Observed levels of cognitive impairment were less than had been predicted from previous studies. There was no difference in the groups in cognitive change scores at five days or three months. Group mean analysis showed significant time factors for all four tests but not for interactions or for the lexipafant group. A composite cognitive index, based on the aggregate of four normally distributed tests, showed a significant effect for timing of the test but not for the lexipafant group or interaction. Age, but not duration of bypass, was the most important determinant of postoperative cognitive impairment.ConclusionsThe neuroprotective PAF antagonist lexipafant did not differentially reduce the level of cognitive impairment after CABG as determined by power estimates derived from published studies. The strongest predictors of cognitive impairment were age and timing of the test after operation.
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