UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011761 |
|---|---|
| Receipt number | 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 | 2025/02/15 15:16:26 |
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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
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
kengo@ndmc.ac.jp
Sponsor or person
Institute
National Defense Medical College
Institute
Department
Personal name
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
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
Completed
Date of protocol fixation
| 2013 | Year | 07 | Month | 24 | Day |
Date of IRB
| 2013 | Year | 09 | Month | 13 | Day |
Anticipated trial start date
| 2013 | Year | 09 | Month | 13 | Day |
Last follow-up date
| 2018 | Year | 09 | Month | 13 | Day |
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
| 2025 | Year | 02 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013753
