UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023720 |
|---|---|
| Receipt number | R000027270 |
| Scientific Title | Continuous Warfarin (Antithrombin therapy) administration versus Heparin bridge therapy in post colon polypectomy hemorrhage |
| Date of disclosure of the study information | 2016/09/01 |
| Last modified on | 2021/08/23 18:06:42 |
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Basic information
Public title
Continuous Warfarin (Antithrombin therapy) administration versus Heparin bridge therapy in post colon polypectomy hemorrhage
Acronym
WHICH study
Scientific Title
Continuous Warfarin (Antithrombin therapy) administration versus Heparin bridge therapy in post colon polypectomy hemorrhage
Scientific Title:Acronym
WHICH study
Region
| Japan |
Condition
Condition
colon polyp
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To prove that continued warfarin therapy
is noninferior heparin bridge therapy for the incidence of post polypectomy and EMR bleeding.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the incidence of post polypectomy and EMR bleeding
Key secondary outcomes
1 cumulative post polypectomy and EMR bleeding rate
2 the rate of overt bleeding which dose not satisfy the definiton of post polypectomy and EMR bleeding
3 the rate of immediate bleeding requiring endoscopic intervention
4 immediate bleeding requiring angiography or surgery or blood transfusion
5 general incidence of bleeding
6 risk factors for post polypectomy and EMR bleeding
7 days of hospital stay
8 the incidence of thromboembolism
9 PT-INR at 28 days after polypectomy and EMR
10 the incidence of serious adverse event
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
a heparin bridging therapy group
Patients stopped taking warfarin at the 4 days before the procedure.Administration of heparin was started at the day when interruption of warfarin. The prothrombin time-international ratio (PT-INR) for warfarin and activated partial thromboplastin (APTT) for heparin were monitored to check the anticoagulant effect. The dose of heparin was started 10000~20000 unit /day. Heparin was stopped 3 hours before the procedure after the disappearance of the anticoagulant effect was confirmed. After the procedure, heparin, warfarin was resumed as soon as possible after confirming the absence of bleeding. The patients continued to take heparin until the PT-INR was within the target value after starting the administration of warfarin.
Interventions/Control_2
Patiets continue to take warfarin
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 with colorectal polyp becoming the indication of polypectomy or EMR.
2)Patients taking warfarin for more than 2 weeks before the procedure.
3)Patients is more than 20 years old.
4)obtaining the consent of the patient
Key exclusion criteria
1)Patients have already registered
2)Patients with inflammatory bowel disease, familial adenomatous polyposis, or Peutz-Jeghers syndrome
3)We cannot observe the progress of the patients
4)patients with bleeding within 6 weeks before the procedure
5)Patients who undergo hemodialys
6)Plt is less than 50000/mm3
7)Patients with the abnormality in blood coagulation ability
8)Woman who is during pregnancy
9)Patients are nursing mothers
10)Patients have an allergy to warfarin or heparin.
11)The attending physician has determined that it is difficult to entry
Target sample size
316
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuaki Nagami |
Organization
Osaka City University Graduate School of Medicine
Division name
Department of Gastroenterology
Zip code
Address
1-4-3, Asahimachi, Abeno-ku, Osaka, 545-8585, Japan
TEL
06-6645-3811
yasuaki-75@med.osaka-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasuaki Nagami |
Organization
Osaka City University Graduate School of Medicine
Division name
Department of Gastroenterology
Zip code
Address
1-4-3, Asahimachi, Abeno-ku, Osaka, 545-8585, Japan
TEL
06-6645-3811
Homepage URL
yasuaki-75@med.osaka-cu.ac.jp
Sponsor or person
Institute
Osaka City University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Osaka City University Graduate School of Medicine
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
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 | 09 | Month | 01 | 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
No longer recruiting
Date of protocol fixation
| 2016 | Year | 08 | Month | 04 | Day |
Date of IRB
| 2016 | Year | 08 | Month | 04 | Day |
Anticipated trial start date
| 2016 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 11 | 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
| 2016 | Year | 08 | Month | 22 | Day |
Last modified on
| 2021 | Year | 08 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027270
