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A randomized phase 2 trial which 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.

A randomized phase 2 trial which 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. - A randomized phase 2 trial of AT-III products in infectious DIC.

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000015105
Enrollment
40
Registered
2014-09-10
Start date
2007-04-01
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

advanced hepatobiliary and pancreatic cancer patients

Interventions

500 IU of AT-III, 60 min. intravenous infusion, 3 times every 8 hours 1,500 IU of AT-III, 60 min. intravenous infusion in a day

Sponsors

Osaka Medical Center for Cancer and Cardiovascular Diseases Department of Medical Oncology
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) advanced hepatobiliary and pancreatic cancer patients 2) acute DIC 3) AT-III activity less than 70% 4) PS 0-2 adults with informed concent with cocuments

Exclusion criteria

Exclusion criteria: pregnat or possible pregnat women

Design outcomes

Primary

MeasureTime frame
AT-III activity after 72 hours

Secondary

MeasureTime frame
1) DIC score after 72 hours 2) DIC score after 7 days 3) SIRS score after 72 hours 4) pyrexia rate at the time of 24 hours and 72 hours later

Countries

Japan

Contacts

Public ContactTatsuya Ioka

Osaka Medical Center for Cancer and Cardiovascular Diseases Department of Medical Oncology

ioka-ta@mc.pref.osaka.jp06-6972-1181

Outcome results

None listed

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