UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000019233
Receipt number R000022225
Scientific Title Prospective study about blood clotting ability abnormality and the deep vein thrombosis in the COPD
Date of disclosure of the study information 2015/10/05
Last modified on 2017/04/05 12:46:02

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Basic information

Public title

Prospective study about blood clotting ability abnormality and the deep vein thrombosis in the COPD

Acronym

Blood clotting ability abnormality and deep vein thrombosis of the COPD

Scientific Title

Prospective study about blood clotting ability abnormality and the deep vein thrombosis in the COPD

Scientific Title:Acronym

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

1st name
Middle name
Last name Mika Saigusa

Organization

Shizuoka General Hospital

Division name

The faculty of Respiratory medicine

Zip code


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

1st name
Middle name
Last name Mika Saigusa

Organization

Shizuoka General Hospital

Division name

The faculty of Respiratory medicine

Zip code


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 or person

Institute

Shizuoka General Hospital, The faculty of Respiratory Medicine

Institute

Department

Personal name



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)



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

2015 Year 10 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

Preinitiation

Date of protocol fixation

2015 Year 10 Month 02 Day

Date of IRB


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



Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022225


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name