UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Prospective study about blood clotting ability abnormality and the deep vein thrombosis in the COPD
Title of the study (Brief title)	Blood clotting ability abnormality and deep vein thrombosis of the COPD
Region	Japan

Condition
Condition	COPD
Classification by specialty	Pneumology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We examine presence or absence of blood clotting ability abnormality in the COPD and DVT merger frequency.
Basic objectives2	Others
Basic objectives -Others	We examine presence or absence of blood clotting ability abnormality in the COPD and DVT merger frequency.
Trial characteristics_1	Others
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	Frequency of DVT
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	The patients that less than 70% of ratio of the forced expiratory volume in one second (FEV1/FVC) were confirmed or COPD was strongly suspected in a pulmonary function test in image findings, and under ratio of the forced expiratory volume in one second 70% were confirmed by a later pulmonary function test. The patients who became the unplanned hospitalization to this hospital respiratory apparatus internal medicine.
Key exclusion criteria	The patients who have DVT pointed out prior to admission. The patients whom doctor attending judged to be inadequate as an object of this study. The patients that it is difficult to obtain consent by disturbance of consciousness or a cognitive function decrease.
Target sample size	75

Research contact person
Name of lead principal investigator	Mika Saigusa
Organization	Shizuoka General Hospital
Division name	The faculty of Respiratory medicine
Address	4-27-1 Kita-ando, Aoi ward, Shizuoka City, Shizuoka
TEL	054-247-6111
Email	mika-saigusa@i.shizuoka-pho.jp

Public contact
Name of contact person	Mika Saigusa
Organization	Shizuoka General Hospital
Division name	The faculty of Respiratory medicine
Address	4-27-1 Kita-ando, Aoi ward, Shizuoka City, Shizuoka
TEL	054-247-6111
Homepage URL	http://www.shizuoka-pho.jp/sogo/section/clinical-research/clinical-trial/index.html
Email	mika-saigusa@i.shizuoka-pho.jp

Sponsor
Institute	Shizuoka General Hospital, The faculty of Respiratory Medicine
Institute
Department

Funding Source
Organization	University of Shizuoka
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	2015 Year 10 Month 05 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2015 Year 10 Month 02 Day
Anticipated trial start date	2015 Year 10 Month 05 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Study design:Cohort study Recruitment of subjects method:The patients who were equal to criteria for selection in the patients admitted to this hospital in October, 2020 from October, 2015.

Management information
Registered date	2015 Year 10 Month 04 Day
Last modified on	2017 Year 04 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000022225