The subcommittee undertook a discussion of dysfibrinogenemia including a general overview of dysfibrinogens from the standpoint of structural and genetic abnormalities and correlative dysfunction. Drs. Michio Matsuda and Susan Lord made formal presentations. Drs. Drs. Jose Martinez and Steve Brennan were unable to be at the meeting. The subcommittee expressed the view that it would be useful to compile and publish an updated and annotated summary of dysfibrinogens, including afibrinogenemia and hypofibrinogenemia, with emphasis on those with known structural defects. The abnormalities should be primarily identified by the molecular defect but the city name, when available, should be retained. The subcommittee also recommended that the list should serve as a repository for reporting newly characterized dysfibrinogens that are not intended for full publication.

Dr. Michio Matsuda agreed to coordinate the compilation effort with a working party consisting of Drs. Susan Lord, Steve Brennan, Jose Martinez, Michael Mosesson, and Jan McDonagh. Dr. McDonagh has compiled an extensive database on dysfibrinogens and will make this information available to the working party.

Fibrinogen Plasma Standard:

Following the results of an international collaborative study presented by Pattrick Gaffney, the Fibrinogen SSC agreed to recommend to the ECBS of the WHO that the UK NIBSC plasma preparation coded 98/612 should be adopted as the Second International Plasma Standard for Fibrinogen. This standard is defined to contain 2.2 mg of clottable protein per vial.

The subcommittee also discussed the requirement for a plasma standard (Dr. Nicodemo Weinstock presenting) containing high levels of fibrinogen. Dr. Ian Mackie also presented in relation to this topic. There was no consensus and the subcommittee agreed to discuss this question more fully at the next meeting.

Dr. Pattrick Gaffney presented the results of a preliminary study that had been initiated at the Fibrinogen Subcommittee meeting in Ljubljana concerning a fibrinogen concentrate standard. The subcommittee agreed to proceed to an International Collaborative Study using the materials prepared by the UK NIBSC with a defined assay protocol for participants.

Dr. Ronald McIntosh summarized proposals for the standardization of the measurement of other components in fibrin sealants in addition to its principal constituent, fibrinogen. It was agreed that future discussion on the standardized of measurement of these components (e.g., thrombin and Factor XIII), should continue within the Fibrinogen Subcommittee, as this will provide continuity rather than have other constituents discussed as separate subjects in different subcommittees.

Following a presentation by Dr. Rainer Seitz, there was a strong view expressed in the meeting that the European Pharmacopoeia monograph "Fibrin Sealant" is not suitable in its present form for the regulatory characterization of new fibrin sealants. The subcommittee agreed to discuss the monograph at the next meeting with the intention of offering its recommendations to the European Pharmacopoeia and establishing its own view on constituents that should be measured in fibrin sealants.

Drs. Israel Nur and Gilbo Soe presented papers on characteristics of certain fibrin sealant preparations. The subcommittee will continue to hear papers on the characterization of fibrin sealant in the broader sense.