UMIN-CTR Clinical Trial

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
Email	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
Email	maasa_aka@icloud.com

Sponsor
Institute	Sapporo Medical University
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042457