UMIN-CTR Clinical Trial

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
Email	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
Email	yasuaki-75@med.osaka-cu.ac.jp

Sponsor
Institute	Osaka City University Graduate School of Medicine
Institute
Department

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
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 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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000027270