Abstract
423 Background: A randomized phase 2 trial was conducted in order to investigate the most effective administration method of antithrombin (AT) products in patients with disseminated intravascular coagulation (DIC) associated with sepsis during treatment for advanced pancreatic and biliary cancer (aPBC). Methods: Diagnoses of DIC were made according to the criteria of acute DIC of the Japan Association of acute Medicine. We examined 42 patients who were diagnosed with septic DIC and showed a level of AT lower than 70% during treatment for aPBC. The patients were evenly divided into two groups: Group A (21 patients) received continuous infusions of AT products 1500 IU per day for three days, and the group B (21 patients) received intermittent infusions of AT products 500 IU×3 per day for three days. Changes in the coagulation parameters, inflammatory markers, SIRS positive scores, and DIC scores that occurred during treatment were compared between the two groups. Furthermore, the survival outcomes of the patients were evaluated using the Kaplan-Meier method. Results: Before treatment, there were no significant differences between the two groups with respect to their backgrounds. During treatment, statistically significant differences were seen in the platelet counts, D-dimer test results, Fibrinogen levels, and CRP levels between the two groups. However, no differences were observed between the two groups regarding the changes of AT activity levels, SIRS positive scores, and DIC scores. No statistically significant differences were noted between the groups in regards to their survival outcomes (28 day survival rates: 85.7% versus 71.4%, p=0.283). A multivariate analysis indicated that baseline AT activity levels were the sole factor associated with the 28-day survival rates. The survival outcomes didn’t depend on the administration method of AT products. Conclusions: In this trial, we found that baseline AT activity levels were the sole factor associated with the 28-day survival rates. There was no difference in therapeutic effects between the continuous and intermittent infusions of AT products. Clinical trial information: UMIN 000015105.
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