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

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 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

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

Value
https://center6.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