Abstract Number: PB0182
Meeting: ISTH 2020 Congress
Theme: Coagulation and Natural Anticoagulants » Coagulation Factors and Inhibitors
Background: Sulodexide is a mucosal tissue derived glycosaminoglycan of mammalian origin which is clinically used in oral (capsule) and parenteral (ampules) forms for various clinical indications. USP referenced potency of sulodexide is reported to be 95 – 105 U/mg by anti-Xa assay and 30 – 40 U/mg by anti-IIa assay.
Aims: The purpose of this study is to determine the whole blood anticoagulant effect of parenteral preparations of sulodexide and its neutralization by protamine sulfate.
Methods: Parenteral formulations (ampules) containing 600 LSU/2 ml were diluted with saline to make 10 and 100 LSU/ml working solutions. Protamine sulfate was obtained from the Loyola hospital pharmacy and diluted to 1.00 – 0.12 mg/ml. Anticoagulant effects of sulodexide over the concentration range of 1.0 – 0.25 LSU/ml were measured on the Hemachrom ACT instrument in freshly drawn normal human blood (n=5-10). Protamine neutralization studies were carried out at a fixed sulodexide level (1.0 LSU/ml) and variable protamine sulfate levels (50-12.5 µg/ml).
Results: Sulodexide produced a concentration-dependent anticoagulant effect in normal human whole blood over a concentration range of 0.25 – 1.0 LSU/ml in the range of (238 ± 24 to 401 ± 30 seconds) in comparison to saline control (136 ± 12 seconds). Protamine sulfate supplementation at a concentration range of 50 – 12.5 µg/ml produced varying levels of neutralization of the anticoagulant effects of sulodexide (1 LSU/ml).
Conclusions: Parenteral (ampules) sulodexide can be used for anticoagulation in dose dependent fashion and protamine sulfate can be used as an antidote for this agent thus in the event of a shortage of unfractionated heparin.
To cite this abstract in AMA style:
Daravath B, Fareed J, Iqbal O, Kouta A, Hoppensteadt D, Jeske W, Siddiqui F, Lewis M, Lewis B. Anticoagulant Effects of Parenteral Sulodexide as Measured by Activated Clotting Time. Relevance to Dosing in Various Indications [abstract]. Res Pract Thromb Haemost. 2020; 4 (Suppl 1). https://abstracts.isth.org/abstract/anticoagulant-effects-of-parenteral-sulodexide-as-measured-by-activated-clotting-time-relevance-to-dosing-in-various-indications/. Accessed March 21, 2024.« Back to ISTH 2020 Congress
ISTH Congress Abstracts - https://abstracts.isth.org/abstract/anticoagulant-effects-of-parenteral-sulodexide-as-measured-by-activated-clotting-time-relevance-to-dosing-in-various-indications/