UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022520 |
|---|---|
| Receipt number | R000025904 |
| Scientific Title | Prospective analysis of delayed bleeding after colorectal EMR and polypectomy by heparin bridging therapy in patients receiving antithrombotic agents |
| Date of disclosure of the study information | 2016/05/31 |
| Last modified on | 2018/12/04 15:36:51 |
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Basic information
Public title
Prospective analysis of delayed bleeding after colorectal EMR and polypectomy by heparin bridging therapy in patients receiving antithrombotic agents
Acronym
Prospective analysis of delayed bleeding after colorectal EMR and polypectomy by heparin bridging therapy in patients receiving antithrombotic agents
Scientific Title
Prospective analysis of delayed bleeding after colorectal EMR and polypectomy by heparin bridging therapy in patients receiving antithrombotic agents
Scientific Title:Acronym
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
| 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
manabukubota@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
manabukubota@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
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
No longer 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
| 2018 | Year | 12 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025904
