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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000023720
Receipt No. 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 2017/05/09

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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
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 Open public recruiting
Date of protocol fixation
2016 Year 08 Month 04 Day
Date of IRB
Anticipated trial start date
2016 Year 09 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 08 Month 22 Day
Last modified on
2017 Year 05 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027270

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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