UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of warfarin use on bleeding complications: bronchoscopy with transbronchial biopsies for peripheral lesion
Title of the study (Brief title)	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	takamasa hotta
Organization	Shimane University Faculty of Medicine
Division name	Department of Biochemistry
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	takamasa hotta
Organization	Shimane University Faculty of Medicine
Division name	Department of Internal Medicine, Division of Medical Oncology and Respiratory Medicine
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 04 Month 22 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000012885