CLINICAL-EXPERIENCE WITH A HIGHLY PURIFIED FACTOR-IX CONCENTRATE IN PATIENTS UNDERGOING SURGICAL OPERATIONS

The haemostatic efficacy of a new highly purified factor IX concentrat e, prepared by metal chelate affinity chromatography, was assessed in 13 patients with haemophilia B undergoing a variety of surgical operat ions. Four of the patients had developed post-operative thromboembolic complications following previous operations, when treated with a prot hrombin complex concentrate. None of the patients in the present serie s developed any evidence of post-operative thrombotic complications. E ffective haemostasis was achieved in all patients, with the exception of a surgical bleed in one case, and late post-operative bleeding in a second patient when the factor IX activity fell below 20 iu/dl. The p roduct is treated with a solvent-detergent process that destroys lipid -enveloped viruses, while the affinity chromatography process during m anufacture removes in excess of 4 log(10) of a non-lipid-enveloped vir us. In followup studies, none of the patients has shown evidence of fr esh infection from the concentrate, when assessed by virological marke rs. It is concluded that this high-purity concentrate (tradename 'Repl enine') is effective for the treatment of patients with haemophilia B who undergo surgical operations.