Prekallikrein activator levels and side effects with human albumin preparations

Recently the question has been raised whether the presence of prekallikrein activator (PKA) in human blood products for i.v. application could possibly cause adverse reactions in the recipient as observed now and then. Up to now a correlation between both properties is far from being established, even though in the U.S. there has been extensive discussion over some PPL batches containing elevated amounts of PKA, presumed to be causally related to an increased frequency of side reactions. As has been demonstrated in the past through wide clinical experience, human albumin is an exceptionally safe blood product. If at all, side effects sometimes seem to occur related to certain individual lots, the reason for which is still unrevealed. In the pursuit of eventually finding some association between PKA levels in and side reactions with albumin, we performed PKA measurements on a panel of commercial human albumin batches, a few of which had been reported occasionally to cause adverse reactions. The assay procedure was essentially that published (3). BOB PKA reference No 1 was included as a standard. PKA was detected in moderate amounts in huge series of albumin batches without any reported side reactions. We conclude, therefore, that PKA levels in the range of trace amounts cannot be related to side reactions with human albumin preparations.