UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021947 |
|---|---|
| Receipt number | R000025312 |
| Scientific Title | A randomized control trial of heparin bridging versus direct oral anticoagulant (DOAC) replacement in patients who undergo endoscopic resection for colon polyps. (NHOG-DOAC-EMR) |
| Date of disclosure of the study information | 2016/04/18 |
| Last modified on | 2020/12/01 22:57:19 |
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Basic information
Public title
A randomized control trial of heparin bridging versus direct oral anticoagulant (DOAC) replacement in patients who undergo endoscopic resection for colon polyps. (NHOG-DOAC-EMR)
Acronym
A randomized control trial of heparin bridging versus direct oral anticoagulant (DOAC) replacement in patients who undergo endoscopic resection for colon polyps. (NHOG-DOAC-EMR)
Scientific Title
A randomized control trial of heparin bridging versus direct oral anticoagulant (DOAC) replacement in patients who undergo endoscopic resection for colon polyps. (NHOG-DOAC-EMR)
Scientific Title:Acronym
A randomized control trial of heparin bridging versus direct oral anticoagulant (DOAC) replacement in patients who undergo endoscopic resection for colon polyps. (NHOG-DOAC-EMR)
Region
| Japan |
Condition
Condition
Colon polyp
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the superiority of direct oral anticoagulant replacement to heparin bridging in post polypectomy bleeding rate for patients who undergo endoscopic resection for colon polyps.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Post polypectomy bleeding rate
Key secondary outcomes
Hospitalization, endoscopic treatment results, the rate of arterial thromboembolism, severe adverse events, endoscopic execution rate
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine | Maneuver |
Interventions/Control_1
Heparin bridging before endoscopic mucosal resection
Interventions/Control_2
direct oral anticoagulant replacement before endoscopic mucosal resection
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
1)Patients who undergo endoscopic mucosal resection for colon polyps
2)Patients with non valvular atrial fibrillation, and use warfarin for prevention of thrombosis
3)PT-INR is less than 3.0
4)ages over 20 years
5)written informed consent
Key exclusion criteria
1)Plt is less than 50000/mm3
2)Patients who undergo hemodialysis
3)Woman who has a possibility of pregnancy or is during pregnancy
4)Impossible to suspend to one-antiplatelet medication.
5)The attending physician has determined that it is difficult to entry
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | Takuya |
| Middle name | |
| Last name | Yamada |
Organization
National Hospital Organization Osaka National Hospital
Division name
Gastroenterology and Hepatology
Zip code
540-0006
Address
2-1-14, Hoenzaka, Chuo-ku, Osaka
TEL
06-6942-1331
yamada@onh.go.jp
Public contact
Name of contact person
| 1st name | Takuya |
| Middle name | |
| Last name | Yamada |
Organization
National Hospital Organization Osaka National Hospital
Division name
Gastroenterology and Hepatology
Zip code
540-0006
Address
2-1-14, Hoenzaka, Chuo-ku, Osaka
TEL
06-6942-1331
Homepage URL
yamada@onh.go.jp
Sponsor or person
Institute
National Hospital Organization
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Hospital Organization Headquarters Clinical Research Central Ethics Review Committee
Address
2-5-21 Higashigaoka, Meguro-ku, Tokyo
Tel
03-5712-5075
700-kenkyu@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
国立病院機構大阪医療センター（大阪府）、国立病院機構九州医療センター（福岡県）、国立病院機構呉医療センター・中国がんセンター（広島県）、国立病院機構東京医療センター（東京都）、国立病院機構三重中央医療センター（三重県）、国立病院機構災害医療センター（東京都）、国立病院機構函館病院（北海道）、国立病院機構北海道がんセンター（北海道）、国立病院機構金沢医療センター（石川県）、国立病院機構敦賀医療センター（福井県）、国立病院機構東広島医療センター（広島県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 04 | Month | 18 | 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
Completed
Date of protocol fixation
| 2016 | Year | 03 | Month | 04 | Day |
Date of IRB
| 2016 | Year | 04 | Month | 19 | Day |
Anticipated trial start date
| 2016 | Year | 05 | Month | 16 | Day |
Last follow-up date
| 2018 | Year | 05 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 04 | Month | 17 | Day |
Last modified on
| 2020 | Year | 12 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025312
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