PROTAMINE USE DURING PERIPHERAL VASCULAR-SURGERY - A PROSPECTIVE RANDOMIZED TRIAL

Purpose: One hundred twenty patients undergoing aortic reconstruction (40), infrainguinal bypass (49), and carotid endarterectomy (31) were prospectively enrolled into a. double-blind randomized trial to invest igate the utility of routine heparin reversal with protamine. Methods: All patients underwent systemic heparinization with 90 U/kg body weig ht during operation and after revascularization were randomized to rec eive either protamine or saline solution for heparin reversal. Blood l oss was measured throughout the surgical procedure, and indexes of coa gulation and the requirement for blood and blood products were documen ted during operation and the first 24 hours after operation. Results: Plasma heparin concentration, partial thromboplastin time, and activat ed clotting time were significantly higher (p < 0.05) in those receivi ng saline solution at 20 minutes and 1 hour after administration. Tota l surgical blood loss was not significantly different between study gr oups. No significant differences were found in blood product requireme nt, intravenous fluid administered, hematocrit, or wound hematomas bet ween groups at 24 hours. In addition, no difference was seen in the su rgeon's subjective intraoperative assessment of hemostasis after admin istration of either study drug. Furthermore, after study drug administ ration protamine was associated with a deleterious effect on subsequen t intraoperative blood loss (318 +/- 33 ml vs 195 +/- 18 ml, p < 0.05) .Conclusions: Although protamine effectively reverses heparin anticoag ulation, its routine use after elective peripheral vascular surgical r econstruction does not appear to provide any clinical benefit.