Multicenter retrospective study of treatment with recombinant human soluble thrombomoduin (rTM) in severe acute pancreatitis with disseminated intravascular coagulation (DIC)
Not Applicable
- Conditions
- acute pancreatitis
- Registration Number
- JPRN-UMIN000031768
- Lead Sponsor
- Osaka Saiseikai Nakatsu Hospital department of gastroenterology and hepatology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 600
Inclusion Criteria
Not provided
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)
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The rate of change from acute peripancreatic fluid collection (APFC) or Acute necrotic collection (ANC) to walled off necrosis (WON)
- Secondary Outcome Measures
Name Time Method 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