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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023279
Receipt No. R000017022
Scientific Title The necessary of heparin bridging therapy for the patients taking warfarin or Indirect and Direct Factor Xa Inhibitors undergoing colonic endoscopic mucosal resection.
Date of disclosure of the study information 2016/07/21
Last modified on 2018/03/14

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Basic information
Public title The necessary of heparin bridging therapy for the patients taking warfarin or Indirect and Direct Factor Xa Inhibitors undergoing colonic endoscopic mucosal resection.
Acronym Safety of colonic endoscopic mucosal resection in patients taking anticoagulants.
Scientific Title The necessary of heparin bridging therapy for the patients taking warfarin or Indirect and Direct Factor Xa Inhibitors undergoing colonic endoscopic mucosal resection.
Scientific Title:Acronym Safety of colonic endoscopic mucosal resection in patients taking anticoagulants.
Region
Japan

Condition
Condition Colon polyps
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Necessity and safety of heparin bridge therapy in patients taking warfarin or indirect and direct factor Xa Inhibitors undergoing colonic endoscopic mucosal resection.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The bleeding rate of post-endoscopic mucosal resection associated without cessation of indirect and direct factor Xa inhibitors.
Key secondary outcomes The difference in bleeding rate of post-endoscopic polypectomy without cessation of anticoagulant agents compared with the previous rate of heparin bridge theraphy.

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 Treatment
Type of intervention
Maneuver
Interventions/Control_1 Continuing warfarin or indirect and direct factor Xa inhibitors during endoscopic colonic polypectomy
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 Patients taking warfarin or indirect and direct factor Xa inhibitors with planning of endoscopic colonic polypectomy.
Key exclusion criteria Number; more than 4 polyps
Size; more than 10mm
Patients; post heart mechanical valve replacement
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Minoru Fujita
Organization Kawasaki Medical School
Division name Gastroenterology
Zip code
Address 577 Matsushima, Kurashiki city, Okayama, Japan.
TEL 086-462-1111
Email minorufu@med.kawasaki-m.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Minoru Fujita
Organization Kawasaki Medical School
Division name Gastroenterology
Zip code
Address 577 Matsushima, Kurashiki city, Okayama, Japan.
TEL 086-462-1111
Homepage URL
Email minorufu@med.kawasaki-m.ac.jp

Sponsor
Institute Kawasaki Medical School
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor None
Name of secondary funder(s) None

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
2016 Year 07 Month 21 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
46 patients taking warfarin or Xa inhibitor were undergone colonic endoscopic mucosal resection without heparine bridge therapy. Only one patient developed post-procedural bleeding. However, it was not serious state for the patient.
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
2014 Year 08 Month 28 Day
Date of IRB
Anticipated trial start date
2014 Year 08 Month 28 Day
Last follow-up date
2018 Year 02 Month 28 Day
Date of closure to data entry
2018 Year 02 Month 28 Day
Date trial data considered complete
2018 Year 02 Month 28 Day
Date analysis concluded
2018 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2016 Year 07 Month 21 Day
Last modified on
2018 Year 03 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017022

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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