UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025164 |
|---|---|
| Receipt number | R000028946 |
| Scientific Title | The safety evaluation of endoscopic therapy against patients receiving anticoagulants agents. |
| Date of disclosure of the study information | 2016/12/06 |
| Last modified on | 2018/06/09 13:18:44 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
The safety evaluation of endoscopic therapy against patients receiving anticoagulants agents.
Acronym
The safety evaluation of endoscopic therapy during anticoagulants therapy.
Scientific Title
The safety evaluation of endoscopic therapy against patients receiving anticoagulants agents.
Scientific Title:Acronym
The safety evaluation of endoscopic therapy during anticoagulants therapy.
Region
| Japan |
Condition
Condition
Patients undergoing gastrointestinal endoscopic therapy during anticoagulant therapy
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study is aimed to evaluate safety of endoscopic therapy in gastrointestinal tract for patients receiving anticoagulatns without cessation.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Gastrointestinal bleeding during two weeks after endoscopic therapy.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
endoscopic therapy
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
(A)Medical need of gastrointestinal endoscopic therapy.
(B)Receiving anticoagulants agents.
(C)Informed consent.
Key exclusion criteria
(A)INR exceeding the upper limit shown in the guideline by Japanese circulation society.
(B)The patient who takes other antiplatelet agents
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuhide Higuchi |
Organization
Osaka Medical College
Division name
Second department of internal medicine
Zip code
Address
2-7,Daigaku-machi,Takatukishi,Osaka
TEL
0726831221
higuchi@osaka-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | kazuki Kakimoto |
Organization
Osaka Medical College
Division name
Second department of internal medicine
Zip code
Address
2-7,Daigaku-machi,Takatukishi,Osaka
TEL
0726831221
Homepage URL
kazuki1977924@yahoo.co.jp
Sponsor or person
Institute
Osaka Medical College
Institute
Department
Personal name
Funding Source
Organization
Osaka Medical College
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2016 | Year | 12 | Month | 06 | 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
Enrolling by invitation
Date of protocol fixation
| 2016 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 01 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 12 | Month | 06 | Day |
Last modified on
| 2018 | Year | 06 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028946
