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 UMIN000023493
Receipt No. R000026577
Scientific Title Safety and efficacy of perioperative management using direct oral anticoagulants in patients on anticoagulant therapy
Date of disclosure of the study information 2016/08/05
Last modified on 2017/06/21

* 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 Safety and efficacy of perioperative management using direct oral anticoagulants in patients on anticoagulant therapy
Acronym Perioperative management using direct oral anticoagulants
Scientific Title Safety and efficacy of perioperative management using direct oral anticoagulants in patients on anticoagulant therapy
Scientific Title:Acronym Perioperative management using direct oral anticoagulants
Region
Japan

Condition
Condition Status requiring high-risk procedures in gastrointestinal tract during anticoagulant therapy
Classification by specialty
Gastroenterology Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate safety and efficacy of perioperative management using direct oral anticoagulants in patients on anticoagulant therapy
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Complication rate (bleeding and thromboembolism).
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
Interventions/Control_1 perioperative management using direct oral anticoagulants in patients on anticoagulant therapy(-POD28)
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. Medical need of high-risk endoscopic procedures.
2. Comorbidity requiring antcoagulant therapy.
3. Age>=20 years.
4. Maintained major organ function.
5. Performance status(ECOG):0-2.
6. Informed consent.
Key exclusion criteria 1. History of prosthetic heart valve replacement or rheumatic valvular disease.
2. Ccr<15ml/min.
3. Diagnosis of psychiatric diseases.
4. With active bacterial or fungus infection.
5. With uncontrollable hypertension.
6. Disqualified for the study by physicians.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tetsuo Takehara
Organization Osaka university graduate school of medicine
Division name Gastroenterology and hepatology
Zip code
Address Yamadaoka2-2, Suita, Osaka
TEL 06-6879-5111
Email takehara@gh.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshito Hayashi
Organization Osaka university graduate school of medicine
Division name Gastroenterology and hepatology
Zip code
Address Yamadaoka2-2, Suita, Osaka
TEL 06-6879-5111
Homepage URL
Email y.hayashi@gh.med.osaka-u.ac.jp

Sponsor
Institute Department of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine
Institute
Department

Funding Source
Organization n/a
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
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
2016 Year 08 Month 05 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
2016 Year 06 Month 13 Day
Date of IRB
Anticipated trial start date
2016 Year 08 Month 08 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 08 Month 04 Day
Last modified on
2017 Year 06 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026577

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.