Clinical experience with a highly purified factor IX concentrate in patients undergoing surgical operations

Abstract

The haemostatic efficacy of a new highly purified factor IX concentrate, prepared by metal chelate affinity chromatography, was assessed in 13 patients with haemophilia B undergoing a variety of surgical operations. Four of the patients had developed post-operative thromboembolic complications following previous operations, when treated with a prothrombin complex concentrate. None of the patients in the present series developed any evidence of post-operative thrombotic complications. Effective 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 20iu/dl. The product is treated with a solvent-detergent process that destroys lipid-enveloped viruses, while the affinity chromatography process during manufacture removes in excess of 4 log10 of a non-lipid-enveloped virus. In follow-up studies, none of the patients has shown evidence of fresh infection from the concentrate, when assessed by virological markers. It is concluded that this high-purity concentrate (tradenane 'Replenine') is effective for the treatment of patients with haemophilia B who undergo surgical operations.