UMIN-CTR Clinical Trial

Basic information
Public title	Multicenter retrospective study of treatment with recombinant human soluble thrombomoduin (rTM) in severe acute pancreatitis with disseminated intravascular coagulation (DIC)
Acronym	Multicenter retrospective study of treatment with recombinant human soluble thrombomoduin (rTM) in severe acute pancreatitis with disseminated intravascular coagulation (DIC)
Scientific Title	Multicenter retrospective study of treatment with recombinant human soluble thrombomoduin (rTM) in severe acute pancreatitis with disseminated intravascular coagulation (DIC)
Scientific Title:Acronym	Multicenter retrospective study of treatment with recombinant human soluble thrombomoduin (rTM) in severe acute pancreatitis with disseminated intravascular coagulation (DIC)
Region	Japan

Condition
Condition	acute pancreatitis
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	It is aimed to examine "Whether development of WON is different in rTM treatment group or non-treatment group" with multi-center and statistically adequate number of cases with the same severity of background in acute pancreatitis patients.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The rate of change from acute peripancreatic fluid collection (APFC) or Acute necrotic collection (ANC) to walled off necrosis (WON)
Key secondary outcomes	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

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key 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)
Key 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)
Target sample size	600

Research contact person
Name of lead principal investigator	1st name Akihiko Middle name Last name Okada
Organization	Osaka Saiseikai Nakatsu Hospital
Division name	Gastroenterology and Hepatology
Zip code	5300012
Address	2-10-39 Shibata Kitaku, Osaka 530-0012, Japan
TEL	06-6372-0333
Email	a.okada@nakatsu.saiseikai.or.jp

Public contact
Name of contact person	1st name Takaaki Middle name Last name Eguchi
Organization	Osaka Saiseikai Nakatsu Hospital
Division name	Gastroenterology and Hepatology
Zip code	5300012
Address	2-10-39 Shibata Kitaku, Osaka 530-0012, Japan
TEL	06-6372-0333
Homepage URL
Email	egugu0515@yahoo.co.jp

Sponsor
Institute	Osaka Saiseikai Nakatsu Hospital department of gastroenterology and hepatology
Institute
Department

Funding Source
Organization	Osaka Saiseikai Nakatsu Hospital
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Osaka Saiseikai Nakatsu Hospital
Address	2-10-39, Shibata, Kita-ku, Osaka, Japan
Tel	06-6372-0333
Email	egugu0515@yahoo.co.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	大阪府済生会中津病院

Other administrative information
Date of disclosure of the study information	2018 Year 03 Month 19 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 11 Month 14 Day
Date of IRB	2017 Year 07 Month 27 Day
Anticipated trial start date	2017 Year 11 Month 14 Day
Last follow-up date	2019 Year 08 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2020 Year 08 Month 31 Day

Other
Other related information	nothing

Management information
Registered date	2018 Year 03 Month 16 Day
Last modified on	2021 Year 09 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000036267