UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037868 |
|---|---|
| Receipt number | R000043175 |
| Scientific Title | Temporal Trends in the Practice Pattern for Venous Thromboembolism in Japan: Insight from a Nationwide Claim-Based Database 2012-2017, JROAD-DPC Study |
| Date of disclosure of the study information | 2019/08/31 |
| Last modified on | 2020/01/28 12:39:15 |
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Basic information
Public title
Temporal Trends in the Practice Pattern for Venous Thromboembolism in Japan: Insight from a Nationwide Claim-Based Database 2012-2017, JROAD-DPC Study
Acronym
Temporal Trends in the Practice Pattern for Venous Thromboembolism in Japan: Insight from a Nationwide Claim-Based Database 2012-2017, JROAD-DPC Study
Scientific Title
Temporal Trends in the Practice Pattern for Venous Thromboembolism in Japan: Insight from a Nationwide Claim-Based Database 2012-2017, JROAD-DPC Study
Scientific Title:Acronym
Temporal Trends in the Practice Pattern for Venous Thromboembolism in Japan: Insight from a Nationwide Claim-Based Database 2012-2017, JROAD-DPC Study
Region
| Japan |
Condition
Condition
Venous thromboembolism, Pulmonary embolism, Deep vein thrombosis
Classification by specialty
| Medicine in general | Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Recently, direct oral anticoagulants (DOAC) have been introduced for venous thromboembolism (VTE), which might change the management strategies of VTE. However, there has been limited data on the current real-world practice pattern for VTE. Therefore, we sought to evaluate the temporal change in the practice pattern for VTE over time, using a nationwide claim database in Japan.
Basic objectives2
Others
Basic objectives -Others
None
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Outcomes measures in the present analysis were in-hospital all-cause death, length of hospitalization, and cost of hospitalization, which included charges related to drugs, medical materials, food, and personnel.
Key secondary outcomes
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
| 20 | years-old | <= |
Age-upper limit
| 999 | years-old | > |
Gender
Male and Female
Key inclusion criteria
In the current study, we identified 55,582 patients who hospitalized with main diagnosis and/or admission-precipitating diagnosis and/or most resource-consuming diagnosis of VTE at admission based on the International Classification of Diseases 10th Revision (ICD-10). A combination of PE codes and DVT codes was used to identify VTE: PE; I26.0, I26.9 and DVT; I80.0, I80.1, I80.2, I80.3, I80.9, I82.2, I82.3, I82.9, O22.2, O22.3, O22.9, O87.0, O87.1, O87.9.
Key exclusion criteria
Pregnancy
Target sample size
54369
Research contact person
Name of lead principal investigator
| 1st name | Yugo |
| Middle name | |
| Last name | Yamashita |
Organization
Graduate School of Medicine, Kyoto University
Division name
Department of Cardiovascular Medicine
Zip code
606-8507
Address
54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto
TEL
075-751-4255
yyamashi@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Yugo |
| Middle name | |
| Last name | Yamashita |
Organization
Graduate School of Medicine, Kyoto University
Division name
Department of Cardiovascular Medicine
Zip code
606-8507
Address
54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto
TEL
075-751-4255
Homepage URL
yyamashi@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Pfizer Health Research Foundation (Tokyo, Japan)
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
kyoto University Hospital Ethics Committe
Address
Yoshidakonoecho sakyo-ku Kyoto
Tel
075-753-4680
ethcom@kuhp.kyoto-u.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 | 08 | Month | 31 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.ahajournals.org/doi/full/10.1161/JAHA.119.014582?url_ver=Z39.88-2003&rfr_id=ori:rid:cros
Number of participants that the trial has enrolled
54369
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
| 2019 | Year | 04 | Month | 26 | Day |
Date of IRB
| 2019 | Year | 04 | Month | 26 | Day |
Anticipated trial start date
| 2019 | Year | 08 | Month | 01 | 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
| 2019 | Year | 08 | Month | 31 | Day |
Other
Other related information
None
Management information
Registered date
| 2019 | Year | 08 | Month | 31 | Day |
Last modified on
| 2020 | Year | 01 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043175
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| Registered date | File name |
| Research case data | |
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