UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022519
Receipt number R000025879
Scientific Title Prospective study of delayed bleeding after colorectal EMR and polypectomy in patients receiving Rivaroxaban uninterruptedly before retiring
Date of disclosure of the study information 2016/05/31
Last modified on 2016/11/21 20:39:07

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Prospective study of delayed bleeding after colorectal EMR and polypectomy in patients receiving Rivaroxaban uninterruptedly before retiring

Acronym

Prospective study of delayed bleeding after colorectal EMR and polypectomy in patients receiving Rivaroxaban uninterruptedly before retiring(RUBR)

Scientific Title

Prospective study of delayed bleeding after colorectal EMR and polypectomy in patients receiving Rivaroxaban uninterruptedly before retiring

Scientific Title:Acronym

Prospective study of delayed bleeding after colorectal EMR and polypectomy in patients receiving Rivaroxaban uninterruptedly before retiring(RUBR)

Region

Japan


Condition

Condition

colorectal polyps

Classification by specialty

Gastroenterology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

analysis of delayed bleeding after colorectal polypectomy and EMR in patients receiving Rivaroxaban uninterruptedly

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

analysis of delayed bleeding after colorectal polypectomy and EMR for 4 weeks

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine Maneuver

Interventions/Control_1

Before the admission of the colorectal polypectomy about 2 weeks,patients start to take a 15mg tablet of Rivaroxaban before retiring.

Reducing criteria for 10mg Rivaroxaban
Ccr less than50ml/min
Age over75 years old
Body weight less than50kg

Patients admit into the hospital on the day before the polypectomy.
The polypectomy is done in the afternoon with uninterruputed using Rivaroxaban before retiring.
Patients start to eat after two days from the polypectomy.
If bloody stools are not occured,patients are permitted discharge.
They take Rivaroxaban before retiring for 4weeks continuously after the polypectomy,and have occurrence of bloody stools observed.

Interventions/Control_2


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

90 years-old >

Gender

Male and Female

Key inclusion criteria

Patients receiving anticoagulants with colorectal polyps under 20mm diameter

Performance status 0 or 1

WBC over3000/mm3 and under12000/mm3
Hb over9.0g/dL
Plt over100000/mm3
AST,ALT under100IU
T.Bil under2.0mg/dL
Ccr less than1.77mg/dL and Ccr over15ml/min
PT-INR under3 (less than70 years old)
PT-INR under2.6(over70 years old)

Key exclusion criteria

Contraindicated cases for taking Rivaroxaban
Patients with artifical heart valve
Patients with vasucular atrial fibrillation
Liver chirrhosis patients with type B or C in child-pugh classfication
Patients taking azole antifungal drug,the HIV-protease inhihibitors or drugs including cobicistat
Patinens contracting acute infective endocarditis
Women who are or may be pregnant
Patients taking aspirin or Thienopyridine
Dialysis patients
Patients with past history of gastrointestinal bleeding or intracranial hemorrhage

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name manabu kubota

Organization

Asahi General Hospital

Division name

Dept. of Gastroenterology

Zip code


Address

I-1326 Asahi-shi Chiba-ken JAPAN

TEL

0479-63-8111

Email

manabukuboa@hospital.asahi.chiba.jp


Public contact

Name of contact person

1st name
Middle name
Last name manabu kubota

Organization

Asahi General Hospital

Division name

Dept. of Gastroenterology

Zip code


Address

I-1326 Asahi-shi Chiba-ken JAPAN

TEL

0479-63-8111

Homepage URL


Email

manabukuboa@hospital.asahi.chiba.jp


Sponsor or person

Institute

Asahi General Hospital

Institute

Department

Personal name



Funding Source

Organization

Asahi General Hospital

Organization

Division

Category of Funding Organization

Local Government

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 05 Month 31 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 04 Month 06 Day

Date of IRB


Anticipated trial start date

2016 Year 06 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 05 Month 30 Day

Last modified on

2016 Year 11 Month 21 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025879


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name