UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030888 |
|---|---|
| Receipt number | R000035269 |
| 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 |
| Date of disclosure of the study information | 2018/01/24 |
| Last modified on | 2018/12/09 13:46:42 |
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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
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
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
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
yamaguchi@med.tohoku.ac.jp
Sponsor or person
Institute
CAC Croit Corporation
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035269
