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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000011011
Receipt No. R000012885
Scientific Title Effect of warfarin use on bleeding complications: bronchoscopy with transbronchial biopsies for peripheral lesion
Date of disclosure of the study information 2013/06/20
Last modified on 2018/08/30

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Basic information
Public title Effect of warfarin use on bleeding complications: bronchoscopy with transbronchial biopsies
for peripheral lesion
Acronym Effect of warfarin use on bleeding complications: bronchoscopy with transbronchial biopsies
for peripheral lesion
Scientific Title Effect of warfarin use on bleeding complications: bronchoscopy with transbronchial biopsies
for peripheral lesion
Scientific Title:Acronym Effect of warfarin use on bleeding complications: bronchoscopy with transbronchial biopsies
for peripheral lesion
Region
Japan

Condition
Condition Subjects of bronchoscopy during warfarin therapy
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Consider the following items in order to implement safer bronchoscopy.
1. measuring amount of bleeding during bronchoscopy
2. comparing frequency of bleeding and thromboembolism after bronchoscopy

Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1. amount of bleeding during bronchoscopy
2. complications

Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 Interventions; during warfarin therapy
Interventions/Control_2 Control; not use antithrombogenic drug
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. subjects of a bronchoscopy
2. cases written informed consent was obtained
3. cases of suspected to malignant disease for peripheral lesion
4. satisfy following items
Plate >= 50,000/mm3
ALT <= 150 IU/L
AST <= 150 IU/L
T.Bil <= 1.5 mg/dL
Cr <= 1.5 mg/dL
1.5<INR<3.0
Key exclusion criteria 1.medical history of bleeding tendency or hemoptysis
2.concurrent use of steroid therapy
3.cases of needing high invasive procedure (cauterization or stent)
4.cases of emergency examination
5.patients with active concomitant pregnancy
6.patients with serious drug allergic reactions.
7.patients who were deemed inappropriate to the subject of this study by attending physician
Target sample size 120

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name takamasa hotta
Organization Shimane University Faculty of Medicine
Division name Department of Biochemistry
Zip code
Address 89-1 Enya-cho Izumo Shimane 693-8501 JAPAN
TEL 0853-23-2111
Email hotta.takamasa@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name takamasa hotta
Organization Shimane University Faculty of Medicine
Division name Department of Internal Medicine, Division of Medical Oncology and Respiratory Medicine
Zip code
Address 89-1 Enya-cho Izumo Shimane 693-8501 JAPAN
TEL 0853-23-2111
Homepage URL
Email hotta.takamasa@gmail.com

Sponsor
Institute Department of Internal Medicine, Division of Medical Oncology and Respiratory Medicine, Shimane University Faculty of Medicine
Institute
Department

Funding Source
Organization Department of Internal Medicine, Division of Medical Oncology and Respiratory Medicine, Shimane University Faculty 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
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
2013 Year 06 Month 20 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
2013 Year 04 Month 22 Day
Date of IRB
Anticipated trial start date
2013 Year 07 Month 01 Day
Last follow-up date
2018 Year 03 Month 31 Day
Date of closure to data entry
2018 Year 03 Month 31 Day
Date trial data considered complete
2018 Year 03 Month 31 Day
Date analysis concluded
2018 Year 07 Month 01 Day

Other
Other related information

Management information
Registered date
2013 Year 06 Month 20 Day
Last modified on
2018 Year 08 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012885

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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