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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000011761
Receipt No. R000013753
Scientific Title Efficacy of thrombomodulin alpha (rTM) in therapy for disseminated intravascular coagulation (DIC) with acute pancreatitis
Date of disclosure of the study information 2013/09/13
Last modified on 2013/09/13

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Basic information
Public title Efficacy of thrombomodulin alpha (rTM) in therapy for disseminated intravascular coagulation (DIC) with acute pancreatitis
Acronym Efficacy of rTM for DIC with acute pancreatitis
Scientific Title Efficacy of thrombomodulin alpha (rTM) in therapy for disseminated intravascular coagulation (DIC) with acute pancreatitis
Scientific Title:Acronym Efficacy of rTM for DIC with acute pancreatitis
Region
Japan

Condition
Condition DIC with acute pancreatitis
Classification by specialty
Medicine in general Hepato-biliary-pancreatic medicine Hematology and clinical oncology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Establishment of efficacy of thrombomodulin alpha in therapy for DIC with acute pancreatitis
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes 28-day mortality
Key secondary outcomes secession rate of acute DIC score, the change of laboratory values, safety assessment

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Administration of thrombomodulin alpha
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. Patients who suffer from acute pancreatitis with acute DIC score more than 4 points
2. The agreed patients with their own decisions under the sufficient explanation
Key exclusion criteria 1. Patients who have intracranial bleeding, pulmonary hemorrhage, hemorrhage of digestive tract
2. Patients with a history of hypersensitivity to rTM
3. Pregnant or supposed to be pregnant patients
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kengo Tomita
Organization National Defense Medical College
Division name Department of Internal Medicine
Zip code
Address 3-2 Namiki, Tokorozawa-shi, Saitama
TEL 04-2995-1609
Email kengo@ndmc.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kengo Tomita
Organization National Defense Medical College
Division name Department of Internal Medicine
Zip code
Address 3-2 Namiki, Tokorozawa-shi, Saitama
TEL 04-2995-1609
Homepage URL
Email kengo@ndmc.ac.jp

Sponsor
Institute National Defense Medical College
Institute
Department

Funding Source
Organization National Defense Medical College
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 防衛医科大学校病院(埼玉県)

Other administrative information
Date of disclosure of the study information
2013 Year 09 Month 13 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 Open public recruiting
Date of protocol fixation
2013 Year 07 Month 24 Day
Date of IRB
Anticipated trial start date
2013 Year 09 Month 13 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 09 Month 13 Day
Last modified on
2013 Year 09 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013753

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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