UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048252 |
|---|---|
| Receipt number | R000054995 |
| Scientific Title | Association of gastrointestinal bleeding from vascular lesions with platelet aggregation activity and a loss of high-molecular-weight multimers of von Willebrand factor |
| Date of disclosure of the study information | 2022/07/03 |
| Last modified on | 2022/07/03 18:28:37 |
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Basic information
Public title
Association of gastrointestinal bleeding from vascular lesions with platelet aggregation activity and a loss of high-molecular-weight multimers of von Willebrand factor
Acronym
VAPA study
Scientific Title
Association of gastrointestinal bleeding from vascular lesions with platelet aggregation activity and a loss of high-molecular-weight multimers of von Willebrand factor
Scientific Title:Acronym
VAPA study
Region
| Japan |
Condition
Condition
Gastrointestinal hemorrhagic vascular disease and small bowel bleeding
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the relationship between gastrointestinal hemorrhagic vascular disease and platelet aggregation/von Willebrand multimer abnormalities
Basic objectives2
Others
Basic objectives -Others
To determine the relationship between gastrointestinal hemorrhagic vascular disease and atherosclerosis
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Platelet aggregation and von Willebrand multimer in patients with gaastrointestinal hemorrhagic vascular diseases
Key secondary outcomes
Atherosclerosis in patients with gaastrointestinal hemorrhagic vascular diseases
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Ppatients who undergo enteroscopy due to suspected small bowel diseases
2) Patients with gastrointestinal vascular disease who undergo endoscopy
Key exclusion criteria
Patients who do not provide informed consent
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Naoki |
| Middle name | |
| Last name | Ohmiya |
Organization
Fujita Health University
Division name
Department of Advanced Endoscopy
Zip code
4668550
Address
1-98 Dengakugakubo Kutsukake-cho, Toyoake, Aichi
TEL
0562939240
nohmiya@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | Naoki |
| Middle name | |
| Last name | Ohmiya |
Organization
Fujita Health University
Division name
Department of Advanced Endoscopy
Zip code
470-1192
Address
1-98 Dengakugakubo Kutsukake-cho, Toyoake, Aichi
TEL
0562939240
Homepage URL
nohmiya@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita Health University School of Medicine, Department of Advanced Endoscopy
Institute
Department
Personal name
Funding Source
Organization
Tohoku University, Department of Molecular and Cellular Biology, Institute of Development, Aging, and Cancer
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fujita Health University
Address
1-98 Dengakugakubo, Kutsukake-cho
Tel
0562932860
research@fujita-hu.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
藤田医科大学病院（愛知県）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 07 | Month | 03 | 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
200
Results
Open public recruiting
Results date posted
| 2022 | Year | 07 | Month | 03 | Day |
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
Open public recruiting
Date of protocol fixation
| 2021 | Year | 01 | Month | 05 | Day |
Date of IRB
| 2021 | Year | 02 | Month | 05 | Day |
Anticipated trial start date
| 2022 | Year | 07 | Month | 03 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 04 | Month | 15 | Day |
Date trial data considered complete
| 2025 | Year | 05 | Month | 31 | Day |
Date analysis concluded
| 2025 | Year | 08 | Month | 31 | Day |
Other
Other related information
Open public recruiting
Management information
Registered date
| 2022 | Year | 07 | Month | 03 | Day |
Last modified on
| 2022 | Year | 07 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054995
| 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 |
