Protamine use during peripheral vascular surgery: a prospective randomized trial.
Author(s): Dorman BH, Elliott BM, Spinale FG, Bailey MK, Walton JS, Robison JG, Brothers TE,
Cook MH.
Affiliation(s): Department of Anesthesiology, Medical University of South Carolina, Charleston
29425-2207, USA.
Publication date & source: 1995, J Vasc Surg. , 22(3):248-55; discussion 256
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 investigate the utility of
routine heparin reversal with protamine.
METHODS: All patients underwent systemic heparinization with 90 U/kg body weight
during operation and after revascularization were randomized to receive either
protamine or saline solution for heparin reversal. Blood loss was measured
throughout the surgical procedure, and indexes of coagulation and the requirement
for blood and blood products were documented during operation and the first 24
hours after operation.
RESULTS: Plasma heparin concentration, partial thromboplastin time, and activated
clotting time were significantly higher (p < 0.05) in those receiving saline
solution at 20 minutes and 1 hour after administration. Total surgical blood loss
was not significantly different between study groups. No significant differences
were found in blood product requirement, intravenous fluid administered,
hematocrit, or wound hematomas between groups at 24 hours. In addition, no
difference was seen in the surgeon's subjective intraoperative assessment of
hemostasis after administration of either study drug. Furthermore, after study
drug administration protamine was associated with a deleterious effect on
subsequent intraoperative blood loss (318 +/- 33 ml vs 195 +/- 18 ml, p < 0.05).
CONCLUSIONS: Although protamine effectively reverses heparin anticoagulation, its
routine use after elective peripheral vascular surgical reconstruction does not
appear to provide any clinical benefit.
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