PB0399 - Comparative Protamine Sulfate and a novel heparin antagonist for the neutralization of potency adjusted porcine and bovine heparin

Background: Protamine sulfate acts as a heparin antagonist to reverse the anticoagulant effects of heparin through an acid-base reaction. Protamine is commonly used in clinical settings to neutralize heparin-induced anticoagulation in patients following surgery and other bleeding complications. HEPA-Remove is a novel heparin neutralizer thought to exhibit effects similar to protamine.

Aims: The purpose of this study is to compare the neutralization activities of protamine sulfate and HEPA-Remove in various laboratory assays when supplemented in potency adjusted bovine and porcine heparin samples.

Methods: Bovine and porcine heparin samples were adjusted at equivalent USP potencies. The samples were supplemented in blood bank plasma (BBP) in a concentration range of 0-1 U/mL. Protamine sulfate and HEPA-Remove were freshly prepared and added to each heparin sample at a final concentration of 10 mg/mL. Samples were then analyzed in an ACL Top 350 coagulation analyzer to determine their activated partial thromboplastin time (aPTT). Anti-Xa and anti-IIa assays were then conducted by amidolytic methods. Thrombin generation inhibition assays (TGA) studies were carried out. Studies were repeated in duplicate, and then statistical analysis was performed using SigmaPlot two-way ANOVA.

Results: HEPA-Remove and protamine sulfate decreased anticoagulation activity.

Conclusion(s): Bovine and porcine heparin samples were similarly neutralized by protamine sulfate and HEPA-Remove in aPTT, anti-Xa, and anti-IIa studies, with a few exceptions at higher concentrations.