UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031768 |
|---|---|
| Receipt number | 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 | 2021/09/17 14:13:23 |
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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 | 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
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
egugu0515@yahoo.co.jp
Sponsor or person
Institute
Osaka Saiseikai Nakatsu Hospital
department of gastroenterology and hepatology
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036267
