Purpose: Define overt-DIC with and without organ failure by 2001 using clinical criteria and laboratory assays currently available. This definition will be based on the Japanese Ministry of Health criteria. It will include the addition of soluble fibrin as a marker and additional major and minor criteria and degrees of severity based on the duration and rates of change as well as cut-off values of clinical and laboratory parameters.
Goals: These criteria should serve as a basis for monitoring and management as well as diagnosis of this disorder in conventional medical settings. It also should serve as a standard to be used in publishing research data in this area.
Rationale: The hemostatic system is an organ consisting of endothelium and monocyte/macrophage/platelet elements as well as the mediators and regulatory factors (e.g., thrombin, protein C) found in plasma. These components act in a coordinated fashion to regulate clot formation (coag., anticoag.) and clot removal (fib. and antifib.). Acquired DIC (overt and non-overt) arises when the regulatory functions of the endothelium are either overridden or attenuated by inflammatory (sepsis) or by ischemia reperfusion (trauma) events. Though the thrombosis and hemorrhage that often accompanies DIC may not always be a link in the lethal chain of events, the hemostatic organ system is the first to be perturbed and its malfunction is closely linked to and amplifies the inflammatory response. Sepsis, for example, could be described initially as an acute disorder of the vascular reticulo-endothelial system.
Execution: The Japanese, English, and Dutch have been engaged in collaborative studies on primates with our laboratories over the last year. The results are provocative and have engaged their active interest. New, young participants have been added to the committee (Levi, Toh and Wada from Holland, England, and Japan). The most active, experienced current members also are actively engaged, (Blombäck, Sakuragawa, Bokarew, and Frances). Together all have agreed on seven specific questions to be addressed this year. A draft then will be submitted to a group of external advisors (V. Marder, A. Giles, K. Bauer, C. Esmon, B. Dalbach, etc.) for review.
Non-overt DIC: The same approach as described above will be taken. An important difference will be that the newer laboratory procedures including soluble fibrin, TAT, APC/PCI, etc., will come into play in discriminating between compensated and decompensated hemeostatic stress, assuming that eventually they can be used on-line.