UMIN-CTR Clinical Trial

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
Email	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
Email	nohmiya@fujita-hu.ac.jp

Sponsor
Institute	Fujita Health University School of Medicine, Department of Advanced Endoscopy
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054995