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Critical Care |

A Randomized, Controlled, Multicenter Trial of the Effects of Antithrombin on Disseminated Intravascular Coagulation in Patients With Sepsis

Satoshi Gando, MD; Daizoh Saitoh, MD; Hiroyasu Ishikura, MD; Masashi Ueyama, MD; Yasuhiro Otomo, MD; Shigeto Oda, MD; Shigeki Kushimoto, MD; Katsuhisa Tanjoh, MD; Toshihiko Mayumi, MD; Toshiaki Ikeda, MD; Toshiaki Iba, MD; Yutaka Eguchi, MD; Kohji Okamoto, MD; Hiroshi Ogura, MD; Kazuhide Koseki, MD; Yuichiro Sakamoto, MD; Yasuhiro Takayama, MD; Kunihiro Shirai, MD; Osamu Takasu, MD; Yoshiaki Inoue, MD; Kunihiro Mashiko, MD; Takaya Tsubota, MD; Shigeatsu Endo, MD
Author and Funding Information

Japanese Association for Acute Medicine, Tokyo, Japan


Chest. 2013;144(4_MeetingAbstracts):418A. doi:10.1378/chest.1701668
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Abstract

SESSION TITLE: Sepsis and Shock Posters

SESSION TYPE: Original Investigation Poster

PRESENTED ON: Wednesday, October 30, 2013 at 01:30 PM - 02:30 PM

PURPOSE: To test the hypothesis that the administration of antithrombin concentrate improves disseminated intravascular coagulation (DIC), resulting in recovery from DIC and better outcomes in patients with sepsis, randomized, controlled, multicenter trial was conducted at thirteen critical care centers in tertiary care hospitals.

METHODS: Sixty DIC patients with sepsis with antithrombin levels of 50-80% were the participants. The participating patients were randomly assigned to an antithrombin arm receiving antithrombin at a dose of30 IU/kg per day for three days or a control arm treated with no intervention. Due to two protocol violations in the antithrombin arm, 28 antithrombin patients and 30 control patients were included in the intention-to-treat analysis. The primary efficacy end point was improvement of the DIC score and recovery from DIC. The secondary efficacy end point was 28-day all-cause mortality. DIC was diagnosed according to the Japanese Association for Acute Medicine (JAAM) scoring system.

RESULTS: Antithrombin treatment resulted in significantly decreased in DIC scores and better recovery rates from DIC compared with those observed in the control group on day 3. The secondary endpoint of 28-day all-cause mortality did not differ between the two groups.The incidence of minor bleeding complications did not increase, and no major bleeding related to antithrombin treatment was observed related. Antithrombin did not influence the Sequential Organ Failure Assessment score, platelet count or markers of coagulation and fibrinolysis.

CONCLUSIONS: Moderate doses of antithrombin significantly improve DIC scores and increase the recovery rate from DIC without a risk of bleeding in DIC patients with sepsis. Antithrombin therapy has no effect on 28-day all-cause mortality.

CLINICAL IMPLICATIONS: The results of the present study provide a rationale for conducting a powered randomized controlled trial addressing the hypothesis that antithrombin treatment for DIC in patients with severe sepsis may improve DIC, leading to a significant reduction of mortality.

DISCLOSURE: The following authors have nothing to disclose: Satoshi Gando, Daizoh Saitoh, Hiroyasu Ishikura, Masashi Ueyama, Yasuhiro Otomo, Shigeto Oda, Shigeki Kushimoto, Katsuhisa Tanjoh, Toshihiko Mayumi, Toshiaki Ikeda, Toshiaki Iba, Yutaka Eguchi, Kohji Okamoto, Hiroshi Ogura, Kazuhide Koseki, Yuichiro Sakamoto, Yasuhiro Takayama, Kunihiro Shirai, Osamu Takasu, Yoshiaki Inoue, Kunihiro Mashiko, Takaya Tsubota, Shigeatsu Endo

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