UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042235 |
|---|---|
| Receipt number | R000048031 |
| Scientific Title | Venous Thromboembolism in Patients with COVID-19 in Japan Study |
| Date of disclosure of the study information | 2020/10/26 |
| Last modified on | 2021/05/21 11:32:29 |
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Basic information
Public title
Venous Thromboembolism in Patients with COVID-19 in Japan Study
Acronym
VTE and COVID-19 in Japan Study
Scientific Title
Venous Thromboembolism in Patients with COVID-19 in Japan Study
Scientific Title:Acronym
VTE and COVID-19 in Japan Study
Region
| Japan |
Condition
Condition
Coronavirus disease 2019: COVID-19, severe acute respiratory syndrome coronavirus 2: SARS-CoV-2
Classification by specialty
| Medicine in general | Cardiology | Hematology and clinical oncology |
| Infectious disease | Emergency medicine | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The coronavirus disease 2019 (COVID-19) has become a huge threat all over the world as a pandemic, which also could cause venous thromboembolism (VTE), including pulmonary embolism (PE). Based on the concept of a high risk for VTE occurrence in patients with COVID-19, some studies reported potential benefit of anticoagulation for the primary prevention of VTE. However, the optimal strategies for the prevention of VTE in COVID-19 still remain unknown. Additionally, ethnic differences may have notable implications in the presentation of VTE. Unfortunately, there is a scarcity of data on current status of VTE in patients with COVID-19 in Japan. Thus, we are going to conduct the observational study to reveal the current status of VTE in patients with COVID-19 in Japan.
Basic objectives2
Others
Basic objectives -Others
None
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Occurrence of VTE during the hospitalization
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
| 1 | years-old | <= |
Age-upper limit
| 999 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who were admitted to the hospital during the study period and were evaluated by contrast-enhanced CT examinations for chest.
Key exclusion criteria
None
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Norikazu |
| Middle name | |
| Last name | Yamada |
Organization
Kuwana City Medical Center
Division name
Department of Cardiology
Zip code
511-0061
Address
Kuwana City Kotobukicho 3-11
TEL
0594-22-1211
noriyamada7@gmail.com
Public contact
Name of contact person
| 1st name | Yugo |
| Middle name | |
| Last name | Yamashita |
Organization
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
Department of Cardiology, Kuwana City Medical Center
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics committee of Kuwana City Medical Center
Address
Kuwana City Kotobukicho 3-11
Tel
0594-22-1211
noriyamada7@gmail.com
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
| 2020 | Year | 10 | Month | 26 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/34011824/
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
45
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2021 | Year | 05 | Month | 20 | Day |
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
| 2020 | Year | 10 | Month | 14 | Day |
Date of IRB
| 2020 | Year | 10 | Month | 20 | Day |
Anticipated trial start date
| 2020 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 02 | Month | 01 | Day |
Date of closure to data entry
| 2021 | Year | 02 | Month | 13 | Day |
Date trial data considered complete
| 2021 | Year | 02 | Month | 14 | Day |
Date analysis concluded
| 2021 | Year | 02 | Month | 15 | Day |
Other
Other related information
Yamashita Y, Maruyama Y, Satokawa H, Nishimoto Y, Tsujino I, Sakashita H, Nakata H, Okuno Y, Ogihara Y, Yachi S, Toya N, Shingaki M, Ikeda S, Yamamoto N, Aikawa S, Ikeda N, Hayashi H, Ishiguro S, Iwata E, Umetsu M, Kondo A, Iwai T, Kobayashi T, Mo M, Yamada N; Taskforce of VTE and COVID-19 in Japan Study. Incidence and Clinical Features of Venous Thromboembolism in Hospitalized Patients With Coronavirus Disease 2019 (COVID-19) in Japan. Circ J. 2021 May 20. doi: 10.1253/circj.CJ-21-0169. Epub ahead of print. PMID: 34011824.
Management information
Registered date
| 2020 | Year | 10 | Month | 26 | Day |
Last modified on
| 2021 | Year | 05 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048031
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
