UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037245 |
|---|---|
| Receipt number | R000042457 |
| Scientific Title | Investigation of the effect of recombinant human soluble thrombomodulin on the improvement of renal injury and mortality in septic patients with disseminated intravascular coagulation |
| Date of disclosure of the study information | 2019/07/03 |
| Last modified on | 2019/07/03 10:45:50 |
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Basic information
Public title
Investigation of the effect of recombinant human soluble thrombomodulin on the improvement of renal injury and mortality in septic patients with disseminated intravascular coagulation
Acronym
Investigation of the effect of recombinant human soluble thrombomodulin on the improvement of renal injury and mortality in septic patients with disseminated intravascular coagulation
Scientific Title
Investigation of the effect of recombinant human soluble thrombomodulin on the improvement of renal injury and mortality in septic patients with disseminated intravascular coagulation
Scientific Title:Acronym
Investigation of the effect of recombinant human soluble thrombomodulin on the improvement of renal injury and mortality in septic patients with disseminated intravascular coagulation
Region
| Japan |
Condition
Condition
septic DIC
Classification by specialty
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify that administration of rhTM is associated with renal protective effect in sepsis-induced DIC patients and the improvement of prognosis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the dependence of renal replacement therapy after ICU discharge
Key secondary outcomes
the number of renal replacement therapy during ICU stay: the length of renal replacement therapy during ICU stay; the number of days free of continuous renal replacement therapy (CRRT free-days), serum creatinine level at ICU admission, ICU discharge, and hospital discharge, death at 28 days, 90 days, and 180 days
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
septic DIC
Key exclusion criteria
the patients with chronic kidney disease on hemodialysis
the patients who are under 18 years old
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Hiroomi |
| Middle name | |
| Last name | Tatsumi |
Organization
Sapporo Medical University, School of Medicine
Division name
Department of Intensive Care Medicine
Zip code
0608543
Address
South1 West16, Chuo-ku, Sapporo
TEL
011-611-2111
tatsumi@qc4.so-net.ne.jp
Public contact
Name of contact person
| 1st name | Masayuki |
| Middle name | |
| Last name | Akatsuka |
Organization
Sapporo Medical University, School of Medicine
Division name
Department of Anesthesiology
Zip code
0608543
Address
South1 West16, Chuo-ku, Sapporo
TEL
011-611-2111
Homepage URL
maasa_aka@icloud.com
Sponsor or person
Institute
Sapporo Medical University
Institute
Department
Personal name
Funding Source
Organization
Sapporo Medical University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Sapporo Medical University
Address
South1 West16, Chuo-ku, Sapporo
Tel
011-611-2111
ji-rskk@sapmed.ac.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
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 07 | Month | 03 | 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
| 2019 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 06 | Month | 13 | Day |
Anticipated trial start date
| 2019 | Year | 06 | Month | 13 | Day |
Last follow-up date
| 2019 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
retrospective study
Management information
Registered date
| 2019 | Year | 07 | Month | 03 | Day |
Last modified on
| 2019 | Year | 07 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042457
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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