Feasibility analysis of the recombinant human thrombomodulin (rTM) for disseminated intravascular coagulation in the perioperative period of Hepato-Biliary-Pancreatic Surgery

Feasibility analysis of the recombinant human thrombomodulin (rTM) for disseminated intravascular coagulation in the perioperative period of Hepato-Biliary-Pancreatic Surgery - Feasibility analysis of the recombinant human thrombomodulin (rTM) for disseminated intravascular coagulation in the perioperative period of Hepato-Biliary-Pancreatic Surgery

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000009983

Enrollment

Registered

2013-02-06

Start date

2013-02-06

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

Possibly operative cases of Hepato-Biliary-Pancreatic tumor

Interventions

administeration of the recombinant human thrombomodulin

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Possibly resectable hepato-biliary-pancreatic tumor 2. written informed consent 3. over 20years old and below 80 years old 4. PS(ECOG); 0 and 1 5. survival of more than 3 months 6. Tolerable organ function as below WBC >=3,000 /mm3 Neutrocyte>= 1,500/mm3 Platelet>=100,000 /mm3 Hb>=9.0g/dL Total bilirubin: within 1.5 times of normal limit AST, ALT, ALP: within 5 times of normal limit creatinine: within 1.5 times of normal limit

Exclusion criteria

Exclusion criteria: 1. severe bleeding (intracranial bleeding, GI bleeding, Lung bleeding) 2. Patients are likely to cause life-threatening bleeding 3. Patients with a history of cerebrovascular bleeding within one year of 4. not long after the surgery of the central nervous system and trauma 5. Patients with a history of hypersensitivity to heparin or unfractionated protein preparation 6.Pregnant or supposed to be pregnant patient 7. Early death is estimated as well as restored the DIC, the patient seems to be difficult to obtain the data and ensure the efficacy and safety of the investigational drug administration period sufficient 8. Patients were deemed inappropriate investigator

Design outcomes

Primary

Measure	Time frame
safety of the recombinant human thrombomodulin (rTM) for DIC after Hepato-Biliary-Pancreatic surgery	—

Secondary

Measure	Time frame
Liver failure(ISGLS) bleeding transfusion recovery rate of DIC SOFA	—

Countries

Japan

Contacts

Public ContactYu Katayose

Tohoku University Hospital Hepato-Biliary Pancreatic surgery,

kein_h11@surg1.med.tohoku.ac.jp022-717-7205

Outcome results

None listed

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