UMIN-CTR Clinical Trial

Basic information
Public title	Assessment of bleeding in patients with disseminated intravascular coagulation after surgical treatment receiving recombinant human soluble thrombomodulin: A cohort study using DPC database
Acronym	Assessment of bleeding in patients with disseminated intravascular coagulation after surgical treatment receiving recombinant human soluble thrombomodulin: A cohort study using DPC database
Scientific Title	Assessment of bleeding in patients with disseminated intravascular coagulation after surgical treatment receiving recombinant human soluble thrombomodulin: A cohort study using DPC database
Scientific Title:Acronym	Assessment of bleeding in patients with disseminated intravascular coagulation after surgical treatment receiving recombinant human soluble thrombomodulin: A cohort study using DPC database
Region	Japan

Condition
Condition	Disseminated Intravascular Coagulation
Classification by specialty	Medicine in general Cardiology Hematology and clinical oncology Surgery in general Gastrointestinal surgery Vascular surgery Cardiovascular surgery Operative medicine Emergency medicine Intensive care medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the effect of recombinant thrombomodulin preparation (rTM; Product name: Recomodulin), a treatment of disseminated intravascular coagulation (DIC), on the incidence of bleeding adverse events by comparing the group of patients receiving rTM with the group of patients receiving drugs other than rTM, on the supposition that "treatment with rTM in patients diagnosed with post-operative DIC does not increase the frequency of bleeding adverse events more significantly than other treatments."
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The incidence proportion of bleeding adverse events
Key secondary outcomes	The incidence proportion of bleeding adverse events in the case where it is added that a blood transfusion or a hemostatic procedure performed after the DIC treatment.

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
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Interventions/Control_8
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Interventions/Control_10

Eligibility
Age-lower limit	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Patients who are diagnosed with DIC (ICD-10: D65, disseminated intravascular coagulation [defibrination syndrome]) using the international classification of disease (ICD-10) 2. Patients who are identified as inpatients using the outcome information in the hospital admission and discharge data 3. Patients who are identified to have received DIC treatment using the receipt electronic processing codes 4. Patients who are identified to have received medical treatment defined as "Surgery" according to the clinical practice identification name using the receipt electronic processing codes. "Surgery" covers all surgeries including A), B), C) below A) Digestive organ surgery related to the liver, gallbladder, and pancreas B) Other digestive organ surgery(except for the liver, gallbladder, and pancreas) C) Surgery related to the heart/cardiovascular system *Patients will be included in the study even if they have only a short past history (within 30 days from the initial prescription) or no past history prior to the day of initial prescription.
Key exclusion criteria	1. Patients who do not have even 1 record of outcome information or who do not have outcome information in the hospital admission and discharge data at the time of initial diagnosis of DIC 2. Patients aged under 18 years 3. Patients with DIC in the department of gynecology/obstetrics (pregnant or possibly pregnant women to be contraindicated) 4. Patients who died within 2 days after the day of admission 5. Patients who received surgery on a day that is not in the same month as or in the month before the diagnosis of DIC 6. Patients who had not received DIC treatment 7. Patients who had received the initial dose of DIC treatment prior to the day of surgery or more than 1 week after surgery 8. Patients whose blood test data ("peripheral blood general") are not available 9. Patients who had intracranial hemorrhage, pulmonary hemorrhage, or gastrointestinal hemorrhage before DIC treatment (patients to be contraindicated) 10. Patients who had at least 1 dose of rTM, but no initial prescription of rTM on the day of surgery or within 1 week after that
Target sample size	10000

Research contact person
Name of lead principal investigator	1st name Middle name Last name Takuhiro Yamaguchi
Organization	Tohoku University Graduate School of Medicine
Division name	Biostatistics
Zip code
Address	1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, JAPAN
TEL	022-717-7659
Email	yamaguchi@med.tohoku.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Takuhiro Yamaguchi
Organization	Tohoku University Graduate School of Medicine
Division name	Biostatistics
Zip code
Address	1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, JAPAN
TEL	022-717-7659
Homepage URL
Email	yamaguchi@med.tohoku.ac.jp

Sponsor
Institute	CAC Croit Corporation
Institute
Department

Funding Source
Organization	Asahi Kasei Pharma Corporation
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

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

Other administrative information
Date of disclosure of the study information	2018 Year 01 Month 24 Day

Related information
URL releasing protocol
Publication of results	Published

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	Main results already published
Date of protocol fixation	2017 Year 09 Month 07 Day
Date of IRB
Anticipated trial start date	2017 Year 09 Month 07 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	<Observational Study Model> Prospective cohort study <Groups> 1. the group of patients receiving rTM 2. the group of patients receiving drugs other than rTM

Management information
Registered date	2018 Year 01 Month 19 Day
Last modified on	2018 Year 12 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035269

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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