UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Prospective analysis of delayed bleeding after colorectal EMR and polypectomy by heparin bridging therapy in patients receiving antithrombotic agents
Title of the study (Brief title)	Prospective analysis of delayed bleeding after colorectal EMR and polypectomy by heparin bridging therapy in patients receiving antithrombotic agents
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 colrectal polypectomy and EMR by heparin bridging therapy
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	Patients in taking Warfarin admit into the hospital,before the colorectal polypectomy from five to seven days ago. Patients in taking Dabigatoran or Apixaban admit into the hospital,before the polypectomy two days ago. Patients in taking Rivaroxaban or Edoxaban admit into the hospital,on the day before the polypectomy. First day, taking anticoagulants is stopped and heparin bridging therapy is started. Unfractionated heparin is dripped by 10IU/kg at each hour for 24 hours continuously,so that APTT is controlled from one and a half times to twice the standard value . The polypectomy is done in the afternoon,heparin bridging therapy is stopped at 9 a.m. After the polypectomy,heparin bridging therapy is restarted at 9 p.m. Patients in taking Warfarin resume internal use of it,and are examined the blood for PT-INR every morning.If the value of PT-INR is therapic range,heparin bridging therapy is stopped. Patients in taking Dabigatoran,Apixaban or Revaroxaban, heparin bridging therapy is stopped at 9.a.m the day folloing the polypectomy, resume internal use of DOAC at the same time. Patients in taking Edoxaban,heparin bridging therapy is stopped at 9.a.m the day folloing the polypectomy,resume internal use of Edoxaban at 12 a.m. Patients start to eat after two days from the polypectomy. If bloody stools are not occured after heparin bridging therapy,they are permitted discharge. They have occurrence of bloody stools observed for 4weeks after the polypectomy.
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 revaroxaban 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	manabu kubota
Organization	Asahi General Hospital
Division name	Dept. of Gastroenterology
Address	I-1326 Asahi-shi, Chiba-ken JAPAN
TEL	0479-63-8111
Email	manabukubota@hospital.asahi.chiba.jp

Public contact
Name of contact person	manabu kubota
Organization	Asahi General Hospital
Division name	Dept. of Gastroenterology
Address	I-1326 Asahi-shi, Chiba-ken JAPAN
TEL	0479-63-8111
Homepage URL
Email	manabukubota@hospital.asahi.chiba.jp

Sponsor
Institute	Asahi General Hospital
Institute
Department

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)

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

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2016 Year 04 Month 06 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 05 Month 30 Day
Last modified on	2018 Year 12 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000025904