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Evaluation of the Surgical DIC Trial with Antithrombin and Recombinant thrombomodulin Study Group

Evaluation of the Surgical DIC Trial with Antithrombin and Recombinant thrombomodulin Study Group - ESTAR

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000012548
Enrollment
200
Registered
2013-12-11
Start date
2013-12-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inclusion Criteria Patient with 24 hours or more after surgical intervention. Over 4 points by Disseminated intravascular coagulation diagnostic criteria established by the Japanese Association for Acute Medicine Antithrombin activity below 50%. Sepsis criteria of SCCM/ACCP

Interventions

once daily intravenous infusion of 3000 unit of antithrombin concentrate intravenous infusion of 380 unit/kg of recombinant human soluble thrombomodulin after infusion of 1500 unit of antithrombin

Sponsors

EASTAR workshop
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Inclusion Criteria Patient with 24 hours or more after surgical intervention. Over 4 points by Disseminated intravascular coagulation diagnostic criteria established by the Japanese Association for Acute Medicine Antithrombin activity below 50%. Sepsis criteria of SCCM/ACCP

Exclusion criteria

Exclusion criteria: 1.Under 20 years old 2.Patient who cannot obtained its consent 3.Patients who are inadequate to enter this study due to other reasons by physician's judgments. 1.Leukemia 2.Patient treated with radiation/anticancer drug 3.Cirrhosis with Child-Pugh grade C or over 4.Patient with hemorrhagic disease (e.g. peptic ulcer after cerebral hemorrhage) 5.Patients with return of cardiopulmonary arrest 6.Patients who cannot survive after 28days judged by physician 7.Patients with past history of hypersensitivity to ATIII concentrate

Design outcomes

Primary

MeasureTime frame
Improvement rate of coagulation markers at day4.

Countries

Japan

Contacts

Public ContactYutaka Eguchi

Shiga university of medical science Department of Emergency and Intensive care

eguchi@belle.shiga-med.ac.jp077-548-2111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026