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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000014369
Receipt No. R000016716
Scientific Title The risk for bleeding complication after endoscopic biopsy in antithrombotic users.
Date of disclosure of the study information 2014/06/24
Last modified on 2014/06/24

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Basic information
Public title The risk for bleeding complication after endoscopic biopsy in antithrombotic users.
Acronym The risk for bleeding complication after endoscopic biopsy in antithrombotic users.
Scientific Title The risk for bleeding complication after endoscopic biopsy in antithrombotic users.
Scientific Title:Acronym The risk for bleeding complication after endoscopic biopsy in antithrombotic users.
Region
Japan

Condition
Condition antithrombotics users
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the risk for the bleeding complication after the biopsy with or without cessation of antithrombotics.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The incidence of bleeding complication after biopsy.
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

Not applicable
Gender Male and Female
Key inclusion criteria All patients who underwent upper gastrointestinal endoscopic biopsy.
Key exclusion criteria The patinets with disorder of main organs.
Target sample size 3000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Nobuyuki Ara
Organization Tohoku University Hospital
Division name Department of Gastroenterology
Zip code
Address 1-1 Seiryomachi, Aobaku, Sendai, Japan
TEL 022-717-7171
Email nobuara@med.tohoku.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Nobuyuki Ara
Organization Tohoku University Hospital
Division name Department of Gastroenterology
Zip code
Address 1-1 Seiryomachi, Aobaku, Sendai, Japan
TEL 022-717-7171
Homepage URL
Email nobuara@med.tohoku.ac.jp

Sponsor
Institute Department of Gastroenterology, Tohoku University Hospital
Institute
Department

Funding Source
Organization Department of Gastroenterology, Tohoku University Hospital
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2014 Year 06 Month 24 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 Open public recruiting
Date of protocol fixation
2013 Year 05 Month 27 Day
Date of IRB
Anticipated trial start date
2013 Year 06 Month 03 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information This is a prospective observational study for evaluating the risk for bleeding complications after endoscopic biopsy in associated with antithrombotics.

Management information
Registered date
2014 Year 06 Month 24 Day
Last modified on
2014 Year 06 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016716

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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