UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000032017
Receipt No. R000036513
Scientific Title Exploratory research on pharmacological predictors for postoperative bleeding after colon polyp resection in patients taking direct-acting oral anticoagulants
Date of disclosure of the study information 2018/04/01
Last modified on 2018/03/30

* 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 Exploratory research on pharmacological predictors for postoperative bleeding after colon polyp resection in patients taking direct-acting oral anticoagulants
Acronym Exploratory research on pharmacological predictors for postoperative bleeding after colon polyp resection in patients taking DOAC
Scientific Title Exploratory research on pharmacological predictors for postoperative bleeding after colon polyp resection in patients taking direct-acting oral anticoagulants
Scientific Title:Acronym Exploratory research on pharmacological predictors for postoperative bleeding after colon polyp resection in patients taking DOAC
Region
Japan

Condition
Condition colon polyp
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The incidence of postoperative gastrointestinal bleeding when colon polypectomy is performed on patients taking DOAC in accordance with Gastrointestinal Endoscopy Practice Guidelines supplement for patients taking antithrombotic drugs is expected to be approximately 10%. The risk of bleeding is approximately 10 times greater than in patients not taking DOAC. There are as yet no indicators established for monitoring the efficacy of DOAC, so uniform support is provided for all respective patients, but individualized treatment is provided for patients in the high-risk group when predictive markers that may cause gastrointestinal bleeding are identified, which can contribute to prevention of gastrointestinal bleeding. The aim of this study was to clarify predictive markers that may enable extraction of high-risk groups at risk of postoperative gastrointestinal bleeding, among patients taking DOAC who have undergone an endoscopic colon resection in accordance with the Gastrointestinal Endoscopy Practice Guidelines (supplement 2017) for patients taking antithrombotic drugs
Basic objectives2 PK,PD
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes The effect of DOAC trough drug blood concentration (p-Xa activity) on postoperative gastrointestinal bleeding after colon polyp resection in patients taking DOAC
Key secondary outcomes (1) The effect of DOAC (Tmax) drug blood concentration (PXa activity) on postoperative bleeding after colon polyp resection in patients taking DOAC.
(2)The effect of polymorphism of drug-metabolizing enzymes on postoperative bleeding after colon polyp resection.
(3) Effect of blood coagulation markers on postoperative bleeding after colon polyp resection.
(4) Extraction of endoscopic characteristics of colon polyps for postoperative bleeding after colon polyp resection.
(5) Extraction of pathological characteristics of colon polyps for postoperative bleeding after colon polyp resection.
(6) Correlation of CHADs score on postoperative bleeding after colon polyp resection.

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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

Not applicable
Gender Male and Female
Key inclusion criteria 1. Patients aged 20 or older at the date of registration (date consent is obtained) with continuous administration of oral DOAC, who have undergone a colon polyp resection and who have consented to participate in this study.
2. PS: Patients with a performance status of 0 or 1 based on ECOG criteria.
Key exclusion criteria 1. Patients who have not consented to participate in this study.
2. Patients taking 3 or more antithrombotic drugs.
3. Patients with serious complications (heart failure, kidney failure, liver failure, respiratory failure).
4. Patients who are pregnant or breastfeeding.
5. Other patients determined to be unsuitable as clinical study subjects by the principal (sub) investigator.
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mitsushige Sugimoto
Organization Shiga University of Medical Science Hospital
Division name Division of Digestive Endoscopy
Zip code
Address Seta Tsukinowa-cho, Otsu, Shiga, JAPAN
TEL 077-548-2217
Email hqmed@belle.shiga-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masaki Murata
Organization Shiga University of Medical Science
Division name Division of Gastroenterology
Zip code
Address Seta Tsukinowa-cho, Otsu, Shiga, JAPAN
TEL 077-548-2217
Homepage URL
Email mura0531@belle.shiga-med.ac.jp

Sponsor
Institute Division of Digestive Endoscopy, Shiga University of Medical Science Hospital
Institute
Department

Funding Source
Organization no organization.
Organization
Division
Category of Funding Organization Other
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
2018 Year 04 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
2018 Year 03 Month 19 Day
Date of IRB
Anticipated trial start date
2018 Year 03 Month 20 Day
Last follow-up date
2020 Year 12 Month 31 Day
Date of closure to data entry
2021 Year 03 Month 31 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information In this study, We evaluate DOAC trough drug blood concentration (p-Xa activity), DOAC (Tmax) drug blood concentration (p-Xa activity), polymorphism of drug-metabolizing enzymes and blood coagulation markers, before endoscopic colon polyp resection (EMR or polypectomy). We divide presence or absence of after-bleeding and compare these factors in order to clarify predictive markers that may enable extraction of high-risk groups at risk of postoperative gastrointestinal bleeding, among patients taking DOAC who have undergone an endoscopic colon polyp resection.

Management information
Registered date
2018 Year 03 Month 30 Day
Last modified on
2018 Year 03 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036513

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.