The changes in various hemostatic parameters were examined within a period from 7 days before the onset of disseminated intravascular coagulation (DIG) in 114 patients (i.e. in their pre-DIG state). The changes in prothrombin time (PT) ratio and fibrinogen levels were not significant before the onset of DIG. Plasma fibrinogen and fibrin degradation products (FDP) levels before the onset of DIG were high, but these changes were already significant in 110 non-DIG patients examined. Plasma thrombin-antithrombin complex (TAT), plasmin-plasmin inhibitor complex (PPIC), D-dimer and soluble fibrin monomer (SFM) levels were high before the onset of DIG. In the 110 leukemic DIG patients, the plasma SFM levels were significantly increased 5 days before, the plasma TAT levels were significantly increased 3 days before, and the D-dimer levels were significantly increased 1 day before the onset of DIG. The plasma tissue factor and plasminogen activator inhibitor-I levels were not significantly changed before the onset of DIG. The PT ratio, fibrinogen, FDP, platelet count, antithrombin, D-dimer, and PPIC levels at 7 days before the onset of DIC were not significantly different from the corresponding values in the non-DIG group, although the hemostatic molecular markers SFM, D-dimer, and TAT are useful for the diagnosis of pre-DIG. Plasma thrombomodulin levels were significantly increased in these patients who died, and plasma antithrombin and protein G activities markedly reduced in the patients who died. The outcome of the diseases underlying DIG is related to vascular endothelial cell injuries.