UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048592 |
|---|---|
| Receipt number | R000055366 |
| Scientific Title | Prediction of periprocedural Bleeding Event during enDoScopIc submucosal DissEction using total thrombus-formation analysis system study |
| Date of disclosure of the study information | 2022/08/08 |
| Last modified on | 2022/08/04 16:28:02 |
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Basic information
Public title
Prediction of periprocedural Bleeding Event during enDoScopIc submucosal DissEction using total thrombus-formation analysis system study
Acronym
BEDSIDE study
Scientific Title
Prediction of periprocedural Bleeding Event during enDoScopIc submucosal DissEction using total thrombus-formation analysis system study
Scientific Title:Acronym
BEDSIDE study
Region
| Japan |
Condition
Condition
early stage cancer in upper gastrointestinal tract
Classification by specialty
| Gastroenterology | Cardiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate efficacy of total thrombus formation analysis system on predicting bleeding and thrombotic events in patients who undergo endoscopic submucosal dissection.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Hemostasis function assessed by T-TAS, Bleeding events during hospitalization (change of serum hemoglobin level, blood transfusion, unexpected drug withdrawal of antithrombotic drugs), Ischemic events (stroke, myocardial infarction)
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who undergo endoscopic submucosal dissection
Key exclusion criteria
Patients who refuse to participate, emergent cases, patients who changed antithrombotic therapy within seven days of endoscopic submucosal dissection, patients who used heparin as antithrombotic therapy
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Ken |
| Middle name | |
| Last name | Kozuma |
Organization
Teikyo University Hospital
Division name
Department of Cardiology
Zip code
1738606
Address
2-11-1, Kaga, Itabashiku, Tokyo
TEL
03-3964-1211
kozumak@med.teikyo-u.ac.jp
Public contact
Name of contact person
| 1st name | Hirofumi |
| Middle name | |
| Last name | Hioki |
Organization
Teikyo University Hospital
Division name
Department of Cardiology
Zip code
1738606
Address
2-11-1, Kaga, Itabashiku, Tokyo
TEL
03-3964-1211
Homepage URL
hioki.teikyo@gmail.com
Sponsor or person
Institute
Teikyo University
Institute
Department
Personal name
Funding Source
Organization
none
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
Teikyo University Medical Research Ethics Committee
Address
2-11-1, Kaga, Itabashiku, Tokyo
Tel
0339641211
urb-office@teikyo-u.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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 08 | Month | 08 | 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
Preinitiation
Date of protocol fixation
| 2022 | Year | 06 | Month | 10 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 13 | Day |
Anticipated trial start date
| 2022 | Year | 08 | Month | 08 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To evaluate the incidence of clinical events after ESD and assess the relationship between clinical events and hemostasis function.
Management information
Registered date
| 2022 | Year | 08 | Month | 04 | Day |
Last modified on
| 2022 | Year | 08 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055366
| 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 |
