Clinical efficacy of a highly purified SD‐treated factor IX concentrate prepared by conventional chromatography

Abstract

Summary. A highly purified (HP) FIX concentrate was used in 12 patients with haemophilia B in order to prevent bleeding following surgery. The HP FIX concentrate (CRTS, Lille, France) was prepared by ion‐exchange chromatograpy and was SD treated. The patients underwent orthopaedic surgery (3), neurosurgery (3) or multiple dental extraction (6). They were treated for 2–18 days and received 8500 to 102000 FIX units. The mean FIX:C recovery was 0·92 ± 0·20%/U/kg. Satisfactory haemostasis was provided in all patients. None of them experienced thrombotic manifestations. There was no change in FDP or soluble fibrin complexes. Prothrombin fragments one plus two (F1 + 2), thrombin‐antithrombin III complexes (TAT) and cross‐linked fibrin degradation products (D‐dimer) remained in the normal range in one patient treated for 2·5 days for dental surgery. In contrast, elevated levels of F1+2, TAT and D‐dimer were observed in one patient undergoing a bilateral hip arthroplasty treated for 16 consecutive days with the same lot of HP FIX concentrate as the previous patient. There was no seroconversion for HIV, HBV and HCV. These results indicate that the HP FIX concentrate provides satisfactory haemostasis in surgery while avoiding excessive thrombogenic risks. However, some clinical circumstances, such as orthopaedic surgery, are known to be associated with especially high thrombotic risks that must be taken into account in case of FIX replacement.