Multicenter retrospective study of treatment with recombinant human soluble thrombomoduin (rTM) in severe acute pancreatitis with disseminated intravascular coagulation (DIC)

Multicenter retrospective study of treatment with recombinant human soluble thrombomoduin (rTM) in severe acute pancreatitis with disseminated intravascular coagulation (DIC) - Multicenter retrospective study of treatment with recombinant human soluble thrombomoduin (rTM) in severe acute pancreatitis with disseminated intravascular coagulation (DIC)

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000031768

Enrollment

600

Registered

2018-03-19

Start date

2017-11-14

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

acute pancreatitis

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) 18 years old and over 2) Patients diagnosed as moderate or severe in Revised Atlanta classification 3) Patients who developed acute pancreatitis within the study period and were hospitalized and treated 4) Patients in which contrast-enhanced CT was imaged within 3 days of hospitalization 5) Patients with APC or ANC which is acute Local Complication were admitted in contrast-enhanced CT (CE-CT) performed in 4) 6) Abdominal CT (with or without CE-CT) or abdominal MRI was taken within 4 to 12 weeks after onset A patient satisfying all of the above 1) - 6)

Exclusion criteria

Exclusion criteria: 1) Patients with severe underlying disease (heart failure, liver failure, renal failure, blood disease, immune disease, malignancy, neurological disease, immunosuppressive drugs etc) 2) traumatic pancreatitis 3) Patients who underwent invasive treatment to APFC / ANC within 4 weeks of onset 4) Patients in which consent were not obtained for cooperation or participation in research 5) Patients with treatment or contrast agent allergy 6) Patients judged by research doctors as inappropriate as research subjects A patient satisfying one of the above 1) -6)

Design outcomes

Primary

Measure	Time frame
The rate of change from acute peripancreatic fluid collection (APFC) or Acute necrotic collection (ANC) to walled off necrosis (WON)	—

Secondary

Measure	Time frame
1) Prognosis with or without complication of WON; 30 days after onset of mortality, 180 days after onset of morbidity (or 180 days survival rate) 2) Number of imaging tests after the onset of pancreatitis (one year after onset), medical expenses for imaging test (1 year after onset) 3) Length of ICU stay (days), Length of hospital stay (days) 4) Complications of rTM administration 5) Incidence of WON within 4 to 12 weeks of acute pancreatitis onset in patients with acute pancreatitis with DIC	—

Measure

Time frame

1) Prognosis with or without complication of WON; 30 days after onset of mortality, 180 days after onset of morbidity (or 180 days survival rate) 2) Number of imaging tests after the onset of pancreatitis (one year after onset), medical expenses for imaging test (1 year after onset) 3) Length of ICU stay (days), Length of hospital stay (days) 4) Complications of rTM administration 5) Incidence of WON within 4 to 12 weeks of acute pancreatitis onset in patients with acute pancreatitis with DIC

—

Countries

Japan

Contacts

Public ContactTakaaki Eguchi

Osaka Saiseikai Nakatsu Hospital Gastroenterology and Hepatology

egugu0515@yahoo.co.jp06-6372-0333

Outcome results