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

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Abstract
Summary: 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.