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Multicenter clinical experience with recombinant soluble thrombomodulin for disseminated intravascular coagulation

Takeshi Ogura¹, Takaaki Eguchi², Mio Amano³

¹2nd Department of Internal Medicine, Osaka Medical College, Osaka, Japan.

Thrombosis Research

|February 20, 2019

Insights

Recombinant human soluble thrombomodulin (rTM) may improve disseminated intravascular coagulation (DIC) resolution in severe acute cholecystitis (AC). This study found higher DIC resolution rates with rTM, though mortality did not differ significantly.

Area of Science:

Gastroenterology
Hematology
Critical Care Medicine

Background:

Severe acute cholecystitis (AC) involves organ dysfunction and can lead to disseminated intravascular coagulation (DIC).
DIC diagnosis in AC can delay critical surgical intervention.
Recombinant human soluble thrombomodulin (rTM) is a potential treatment for DIC, but its efficacy in AC-induced DIC is unevaluated.

Purpose of the Study:

To evaluate the clinical impact of rTM on sepsis-induced DIC in patients with severe AC.
To assess the effectiveness of rTM in improving DIC resolution and patient outcomes.

Main Methods:

A retrospective multicenter study included 42 patients with sepsis-induced DIC from severe AC.
Patients were treated with or without rTM (Recomodulin® Injection) at varying doses.
Data on coagulation parameters, DIC resolution, and mortality were collected and analyzed.

Main Results:

Platelet count was significantly increased at day 7 in the rTM group.
DIC resolution rates on day 7 were significantly higher in the rTM group (94.1%) compared to the control group (68.0%).
Mortality rates due to sepsis-induced DIC did not significantly differ between the groups.

Conclusions:

rTM may enhance the resolution rate of sepsis-induced DIC in severe AC.
Larger studies are needed to confirm these findings and validate the use of rTM in this clinical setting.

Read full analysis

Abstract

Background:

Severe acute cholecystitis (AC) is defined by the association of organ dysfunction, including hematological dysfunction, with AC. Severe AC is often complicated by disseminated intravascular coagulation (DIC), the diagnostic criteria of which overlap with AC-associated hematological dysfunction. Since the diagnosis of DIC often delays definitive surgical management of severe AC, treatment of DIC in this setting is clinically important. Recombinant human soluble thrombomodulin (rTM) is a new agent that has proven clinically useful for treating DIC. However, the relevance of rTM to sepsis-induced DIC caused by AC has not been clinically evaluated. This retrospective multicenter study aimed to determine the clinical impact of rTM on sepsis-induced DIC caused by AC.

Methods:

This retrospective multicenter study initially included 68 consecutive patients and proceeded between July 2014 and December 2017. The inclusion criterion was sepsis-induced DIC caused by severe AC due to benign disease. Sixteen of the 68 patients were excluded in this study due to having advanced malignant tumors. Finally, 42 patients were enrolled in this study. We treated DIC with AC using Recomodulin® Injection (rTM) at doses of 130 or 380 U/kg/day.

Results:

17 and 25 patients were treated with and without rTM, respectively. Values on days 3 and 7 did not significantly differ between the groups for PT-INR (P = 0.38 and P = 0.16, respectively) and FDP (P = 0.06 and P = 0.08, respectively), and PLT was significantly increased in the rTM group at day 7 (P = 0.03). Resolution rates of DIC on day 7 were significantly higher in the group treated with, than without rTM (94.1% [16/17] vs. 68.0% [17/25], P = 0.04). Two patients in each group died of sepsis-induced DIC associated with severe AC, and thus mortality rates did not significantly differ.

Conclusions:

rTM can may be improve the resolution rate of sepsis-induced DIC due to severe AC. Future studies should include more patients to validate our findings.

Keywords:

Acute cholecystitis Disseminated intravascular coagulation Recombinant soluble thrombomodulin Thrombosis

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