UMIN-CTR Clinical Trial

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

colon polyp

Classification by specialty

Gastroenterology

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

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

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

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

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

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

Institute

Osaka City University Graduate School of Medicine

Institute

Department

Personal name

Organization

Osaka City University Graduate School of Medicine

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2016

Year

09

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related 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