Safety and efficacy of intravenous enoxaparin for carotid endarterectomy: a prospective randomized pilot trial.

摘要: Objective This prospective, randomized, single-center, open-label pilot study evaluated the safety and efficacy in carotid surgery of a single intraoperative bolus body weight–adjusted enoxaparin compared with unfractionated heparin. Methods Symptomatic asymptomatic patients high-grade internal artery stenosis were included. The primary objective was to evaluate perioperative (incidence thromboembolic ischemic stroke). secondary safety, including avoidance hematoma at site surgery, gastrointestinal bleeding, rate blood transfusions, occurrence heparin-induced thrombocytopenia. Results From July 2005 June 2006, 338 consecutive undergoing endarterectomy enrolled; these, 115 did not fulfill inclusion criteria, 63 refused participate. remaining 160 assigned 3:1 randomization receive (0.5 mg/kg) or heparin (5000 IU) intraoperatively as an intravenous (120 40 patients, respectively). mean patient age 70.3 years (range, 43.3-94.7 years), 54 women. Internal 55% symptomatic 45%. difference baseline characteristics between these groups significant. cerebral embolic events 0.8% group (n = 1) 2.5% 1). severe bleeding complications 1.7% 2) 5% 2; P > .05). No case thrombocytopenia observed. Conclusion found no during events. A large multicenter trial seems be warranted.