UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000036484
Receipt number R000041572
Scientific Title ABO blood group is an independent risk factor for delayed post-procedural bleeding after colorectal endoscopic resection: a multi-center case-control study
Date of disclosure of the study information 2019/04/13
Last modified on 2019/10/11 09:18:23

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Basic information

Public title

ABO blood group is an independent risk factor for delayed post-procedural bleeding after colorectal endoscopic resection: a multi-center case-control study

Acronym

ABO blood group is an independent risk factor for delayed bleeding after colorectal endoscopic resection

Scientific Title

ABO blood group is an independent risk factor for delayed post-procedural bleeding after colorectal endoscopic resection: a multi-center case-control study

Scientific Title:Acronym

ABO Blood group is an independent risk factor for delayed bleeding after colorectal endoscopic resection

Region

Japan


Condition

Condition

Colorectal tumors

Classification by specialty

Gastroenterology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

This study aimed to investigate whether O blood group is an independent risk factor for delayed post-procedural bleeding after colorectal endoscopic resection

Basic objectives2

Others

Basic objectives -Others

To confirm clinical impact

Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

The incidence of delayed post-procedural bleeding within 28 days from the procedure.

Key secondary outcomes



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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Consecutive patients who admitted to 4 hospitals to undergo endoscopic resection during the study period

Key exclusion criteria

1) patients who have never undergone blood group screening in each hospital or whose ABO blood group was undetermined despite the screening test
2) patients who underwent endoscopic resection without interrupting anti-platelets or anti-coagulants. For patients who met the eligibility criteria,

Target sample size

8625


Research contact person

Name of lead principal investigator

1st name Kazuki
Middle name
Last name Sumiyama

Organization

The Jikei University School of Medicine

Division name

Department of Endoscopy

Zip code

1058471

Address

3-25-8, Nishi-Shimbashi, Minato-ku, Tokyo, Japan

TEL

03-3433-1111

Email

kaz_sum@jikei.ac.jp


Public contact

Name of contact person

1st name Hiroto
Middle name
Last name Furuhashi

Organization

The Jikei University School of Medicine

Division name

Department of Endoscopy

Zip code

1058471

Address

3-25-8, Nishi-Shimbashi, Minato-ku, Tokyo, Japan

TEL

03-3433-1111

Homepage URL


Email

ms04furuhashi@gmail.com


Sponsor or person

Institute

The Jikei University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

The Jikei University School of Medicine

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Institutional Review Board of The Jikei University School of Medicine

Address

3-25-8, Nishi-Shimbashi, Minato-ku, Tokyo, Japan

Tel

03-3433-1111

Email

rinri@jikei.ac.jp


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

2019 Year 04 Month 13 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

Completed

Date of protocol fixation

2018 Year 12 Month 12 Day

Date of IRB

2019 Year 01 Month 15 Day

Anticipated trial start date

2019 Year 04 Month 13 Day

Last follow-up date

2019 Year 04 Month 20 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

We extracted cases who underwent endoscopic resection for colorectal tumors between January 2014 and December 2017 using endoscopy database (Solemio ENDO, Olympus medical systems Co., Tokyo, Japan; NEXUS, Fujifilm Co., Tokyo, Japan) and reviewed those medical records in four hospitals (The Jikei University Hospital, Tokyo, Japan; Katsushika medical center, Tokyo, Japan; The Jikei University Daisan Hospital, Tokyo, Japan; and The Jikei University Kashiwa Hospital, Chiba, Japan).


Management information

Registered date

2019 Year 04 Month 12 Day

Last modified on

2019 Year 10 Month 11 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041572


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name