A novel rat model of thrombogenicity: its use in evaluation of prothrombin complex concentrates and high purity factor IX concentrates.
A non-stasis rodent model of thrombogenicity has been used for dose-ranging studies with a conventional prothrombin complex concentrate (PCC) and to evaluate high purity factor IX concentrates from different manufacturers. Fibrin monomer (soluble fibrin) and fibrinopeptide A (FPA) were monitored before and after infusion of test solution. FPA was found to be the more sensitive and reproducible indicator of thrombogenicity and exhibited a dose-related elevation after infusion of the PCC at doses of between 100-300 IU/kg. In contrast the amounts of FPA generated after 300 IU/kg of the high purity factor IX products were similar to control infusions of albumin.
McLaughlin
L F
LF
National Science Laboratory, Scottish National Blood Transfusion Service, Edinburgh, UK.
Drummond
O
O
MacGregor
I R
IR
D000818:Animals; D004195:Disease Models, Animal; D004305:Dose-Response Relationship, Drug; D005164:Factor IX / Q000008:administration & dosage / Q000009:adverse effects* / Q000302:isolation & purification; D005260:Female; D005337:Fibrin / Q000378:metabolism; D005344:Fibrinopeptide A / Q000378:metabolism; D011516:Prothrombin / Q000008:administration & dosage / Q000009:adverse effects*; D051381:Rats; D017207:Rats, Sprague-Dawley; D013927:Thrombosis / Q000097:blood / Q000209:etiology*
D005344:Fibrinopeptide A; D011516:Prothrombin; D005164:Factor IX; D005337:Fibrin