CLINICAL EFFICACY OF A HIGHLY PURIFIED SD-TREATED FACTOR-IX CONCENTRATE PREPARED BY CONVENTIONAL CHROMATOGRAPHY

A highly purified (KP) FIX concentrate was used in 12 patients with ha emophilia B in order to prevent bleeding following surgery. The HP FIX concentrate (CRTS, Lille, France) was;prepared by ion-exchange chroma tograpy and was SD treated. The patients underwent orthopaedic surgery (3), neurosurgery (3) or multiple dental extraction (6). They were tr eated for 2-18 days and received 8500 to 102000 FIX units. The mean FI X:C recovery was 0.92+/-0.20%/U/ kg. Satisfactory haemostasis was prov ided in all patients. None of them experienced thrombotic manifestatio ns. There was no change in FDP or soluble fibrin complexes. Prothrombi n 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 su rgery. In contrast, elevated levels of F1+2, TAT and D-dimer were obse rved in one patient undergoing a bilateral hip arthroplasty treated fo r 16 consecutive days with the same lot of HP FIX concentrate as the p revious patient. There was no seroconversion for HIV, HBV and HCV. The se results indicate that the HP FIX concentrate provides satisfactory haemostasis in surgery while avoiding excessive thrombogenic risks. Ho wever, some clinical circumstances, such as orthopaedic surgery, are k nown to be associated with especially high thrombotic risks that must be taken into account in case of FIX replacement.