![]() |
UMIN-CTR Clinical Trial |
|
![]() |
![]() |
![]() |
![]() |
Name: | UMIN ID: |
Recruitment status | Open public recruiting |
Unique ID issued by UMIN | UMIN000042576 |
Receipt No. | R000048597 |
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 | 2020/11/27 |
Last modified on | 2020/11/27 |
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 |
|
Condition | ||
Condition | colon polyp | |
Classification by specialty |
|
|
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 | |
Trial characteristics_2 | |
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 |
|
|||
Age-upper limit |
|
|||
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 |
|
||||||
Organization | Tokyo Medical University Hospital | ||||||
Division name | Department of Gastroenterological Endoscopy | ||||||
Zip code | 160-8402 | ||||||
Address | 6-1-1 Shinjuku, Shinjuku-ku,Tokyo | ||||||
TEL | 03-3351-6141 | ||||||
mura05310531@gmail.com |
Public contact | |||||||
Name of contact person |
|
||||||
Organization | National Hospital Organization Kyoto Medical Center | ||||||
Division name | Department of Gastroenterology | ||||||
Zip code | 612-8555 | ||||||
Address | 1-1 Mukouhata-cho, Fukakusa, Fushimi-ku, Kyoto | ||||||
TEL | 0756419161 | ||||||
Homepage URL | |||||||
ds110674@outlook.jp |
Sponsor | |
Institute | Department of Gastroenterological Endoscopy, Tokyo Medical University 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 | Tokyo Medical University Hospital |
Address | 6-1-1 Shinjuku, Shinjuku-ku,Tokyo |
Tel | 03-3351-6141 |
mura05310531@gmail.com |
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 |
|
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 |
|
||||||
Date of IRB |
|
||||||
Anticipated trial start date |
|
||||||
Last follow-up date |
|
||||||
Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information | This research is a continuation of the previous research (UMIN000032017) conducted at Shiga University of Medical Science. |
Management information | |||||||
Registered date |
|
||||||
Last modified on |
|
Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048597 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |