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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000031768
Receipt No. R000036267
Scientific Title Multicenter retrospective study of treatment with recombinant human soluble thrombomoduin (rTM) in severe acute pancreatitis with disseminated intravascular coagulation (DIC)
Date of disclosure of the study information 2018/03/19
Last modified on 2018/03/16

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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
Middle name
Last name Akihiko Okada
Organization Osaka Saiseikai Nakatsu Hospital
Division name Gastroenterology and Hepatology
Zip code
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
Middle name
Last name Takaaki Eguchi
Organization Osaka Saiseikai Nakatsu Hospital
Division name Gastroenterology and Hepatology
Zip code
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
Institute
Department

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

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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

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 Enrolling by invitation
Date of protocol fixation
2017 Year 11 Month 14 Day
Date of IRB
Anticipated trial start date
2017 Year 11 Month 14 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information nothing

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


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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