UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053561 |
|---|---|
| Receipt number | R000061113 |
| Scientific Title | Management of antithrombotic agents during emergency endoscopy for upper gastrointestinal bleeding |
| Date of disclosure of the study information | 2024/02/07 |
| Last modified on | 2024/02/07 04:38:16 |
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Basic information
Public title
Management of antithrombotic agents during emergency endoscopy for upper gastrointestinal bleeding
Acronym
Management of antithrombotics for UGIB
Scientific Title
Management of antithrombotic agents during emergency endoscopy for upper gastrointestinal bleeding
Scientific Title:Acronym
Management of antithrombotics for UGIB
Region
| Japan |
Condition
Condition
upper gastrointestinal bleeding
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to compare the outcomes of upper gastrointestinal bleeding (UGIB) during emergency endoscopy between patients taking and not taking antithrombotic agents to inform antithrombotic management.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The success rate of endoscopic hemostasis
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Following the completion of the emergency endoscopic procedure to halt bleeding, every individual patient who was taking antithrombotic agents (Group A) immediately resumed their respective antithrombotic agents.
Interventions/Control_2
Group NA was made up of those who were not taking antithrombotic agents.
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
Individuals aged over 20 years presenting with suspected UGIB necessitating urgent endoscopic intervention; those who received endoscopic hemostasis within 24 hours of the initial symptoms; and patients who were conscious with stable respiratory and cardiovascular functions.
Key exclusion criteria
Exclusions were applied to patients who required endotracheal intubation, those with unstable respiratory and circulatory systems impeding emergency endoscopic procedures, and cases with incomplete data.
Target sample size
389
Research contact person
Name of lead principal investigator
| 1st name | Yamaguchi |
| Middle name | |
| Last name | Daisuke |
Organization
National Hospital Organization Ureshino Medical Center, Ureshino
Division name
Gastroenterology
Zip code
8430393
Address
4279-3 Shimojyukukou, Ureshino city, Saga
TEL
0954431120
daisukehawks@gmail.com
Public contact
Name of contact person
| 1st name | Yamaguchi |
| Middle name | |
| Last name | Daisuke |
Organization
National Hospital Organization Ureshino Medical Center
Division name
Gastroenterology
Zip code
8430393
Address
4279-3 Shimojyukukou, Ureshino city, Saga
TEL
0954431120
Homepage URL
daisukehawks@gmail.com
Sponsor or person
Institute
National Hospital Organization Ureshino Medical Center
Institute
Department
Personal name
Daisuke Yamaguchi
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Saga
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
the Ethics Review Committee of the National Hospital Organization Ureshino Medical Center
Address
4279-3 Shimojyukukou, Ureshino city, Saga
Tel
0954431120
honjo.yoko.vd@mail.hosp.go.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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 02 | Month | 07 | 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
389
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
| 2016 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 25 | Day |
Anticipated trial start date
| 2016 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 02 | Month | 07 | Day |
Last modified on
| 2024 | Year | 02 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061113
| Research Plan | |
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| 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 |
