UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015884
Receipt number R000018338
Scientific Title Mechanisms of thrombus formation in acute pulmonary embolism
Date of disclosure of the study information 2014/12/09
Last modified on 2019/12/13 09:46:58

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Basic information

Public title

Mechanisms of thrombus formation in acute pulmonary embolism

Acronym

Mechanisms of thrombus formation in acute pulmonary embolism

Scientific Title

Mechanisms of thrombus formation in acute pulmonary embolism

Scientific Title:Acronym

Mechanisms of thrombus formation in acute pulmonary embolism

Region

Japan


Condition

Condition

acute pulmonary embolism

Classification by specialty

Cardiovascular surgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To reveal mechanisms of thrombus formation in acute pulmonary embolism

Basic objectives2

Others

Basic objectives -Others

To pathologically evaluate surgical specimens

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

To reveal which cells and cytokines are involved in thrombus formation by assessing surgical specimens.

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

Patients who undergo surgical thrombectomy for acute pulmonary embolism

Key exclusion criteria

none

Target sample size

5


Research contact person

Name of lead principal investigator

1st name Ishida
Middle name
Last name Keiichi

Organization

Chiba University, School of Medicine

Division name

Department of General Medical Science

Zip code

260-8677

Address

1-8-1 Inohana, Chuo-ku, Chiba Inohana, Chuo-ku, Chiba

TEL

043-226-2567

Email

keiichi-ishida@pro.odn.ne.jp


Public contact

Name of contact person

1st name Ishida
Middle name
Last name Keiichi

Organization

Chiba University, School of Medicine

Division name

Department of Cardiovascular Surgery

Zip code

260-8677

Address

1-8-1 Inohana, Chuo-ku, Chiba8-1 Inohana, Chuo-ku, Chiba

TEL

0432262567

Homepage URL


Email

keiichi-ishida@pro.odn.ne.jp


Sponsor or person

Institute

Department of Cardiovascular Surgery, Chiba University, School of Medicine

Institute

Department

Personal name



Funding Source

Organization

none

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Chiba University, School of Medicine

Address

1-8-1 Inohana, Chuo-ku, Chiba

Tel

0432227171-5007

Email

igaku-rinri@office.chiba-u.jp


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

2014 Year 12 Month 09 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

Enrolling by invitation

Date of protocol fixation

2013 Year 11 Month 29 Day

Date of IRB

2013 Year 11 Month 28 Day

Anticipated trial start date

2013 Year 11 Month 29 Day

Last follow-up date

2014 Year 11 Month 29 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

To evaluate pathologically surgical specimens (thrombus).


Management information

Registered date

2014 Year 12 Month 09 Day

Last modified on

2019 Year 12 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018338


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name