UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045537 |
|---|---|
| Receipt number | R000051944 |
| Scientific Title | Tsukuba Ultrasound for Lower Extremity Deep Vein Thrombosis Registry |
| Date of disclosure of the study information | 2021/09/22 |
| Last modified on | 2023/09/25 07:42:23 |
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Basic information
Public title
Tsukuba Ultrasound for Lower Extremity Deep Vein Thrombosis Registry
Acronym
TULIPE Registry
Scientific Title
Tsukuba Ultrasound for Lower Extremity Deep Vein Thrombosis Registry
Scientific Title:Acronym
TULIPE Registry
Region
| Japan |
Condition
Condition
Venous Thromboembolism (Pulmonary embolism and Deep vein thrombosis)
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of the current study is to investigate the contemporary management and outcomes in patients with thromboembolism (pulmonary embolism and deep vein thrombosis) in the real-world clinical practice.
Basic objectives2
Others
Basic objectives -Others
Observational Study
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Death (all-cause death, VTE-related death), Recurrence of symptomatic VTE, Bleeding event
Key secondary outcomes
Acute myocardial infarction, Stroke, Invasive treatment, Postthrombotic syndrome
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
From November 2011 to December 2021,
Patients diagnosed with deep vein thrombosis by lower extremity venous ultrasound
Key exclusion criteria
None
Target sample size
30000
Research contact person
Name of lead principal investigator
| 1st name | Kazuko |
| Middle name | |
| Last name | Tajiri |
Organization
University of Tsukuba
Division name
Department of Cardiology
Zip code
305-8575
Address
1-1-1 Tennodai, Tsukuba, Japan
TEL
029-853-3143
ktajiri@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Kazuko |
| Middle name | |
| Last name | Tajiri |
Organization
University of Tsukuba
Division name
Department of Cardiology
Zip code
305-8575
Address
1-1-1 Tennodai, Tsukuba, Japan
TEL
029-853-3143
Homepage URL
ktajiri@md.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
University of Tsukuba
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
University of Tsukuba
Address
1-1-1 Tennodai, Tsukuba, Japan
Tel
029-853-3143
ktajiri@md.tsukuba.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
筑波大学附属病院（茨城県）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 09 | Month | 22 | 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
Completed
Date of protocol fixation
| 2020 | Year | 10 | Month | 28 | Day |
Date of IRB
| 2020 | Year | 11 | Month | 09 | Day |
Anticipated trial start date
| 2020 | Year | 11 | Month | 09 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
observational study
Management information
Registered date
| 2021 | Year | 09 | Month | 22 | Day |
Last modified on
| 2023 | Year | 09 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051944
