UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022339
Receipt number R000025747
Scientific Title Clinical trial for the practical use of a metalic connector for assisted circulation system
Date of disclosure of the study information 2016/05/23
Last modified on 2019/02/05 13:14:24

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Basic information

Public title

Clinical trial for the practical use of a metalic connector for assisted circulation system

Acronym

Clinical trial for the practical use of a metalic connector for assisted circulation system

Scientific Title

Clinical trial for the practical use of a metalic connector for assisted circulation system

Scientific Title:Acronym

Clinical trial for the practical use of a metalic connector for assisted circulation system

Region

Japan


Condition

Condition

Severe heart failure

Classification by specialty

Cardiovascular surgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

This study is to evaluate that a new metalic connector could decrease the incidence of thromboembolic events in patients with severe heart failure treated with percutaneous cardio-pulmonary support or extracorporeal ventricular assist device support.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

The frequency of exchange of support device accompanied with thrombosis in the connector.
The incidence of thromboembolic events

Key secondary outcomes

30-day mortality
frequency of adverse event (hemorrhagic complications)
renal function (Creatinine)
liver functin (AST, ALT and LDH)


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

No need to know


Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Using a new metalic connector in patinets with severe heart failure treated with circulatory support system

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

7 years-old <=

Age-upper limit

90 years-old >=

Gender

Male and Female

Key inclusion criteria

patients with severe heart failure treated with percutaneous cardio-pulumonary support or extracorporeal vantricular assist device support

Key exclusion criteria

Exclusion criteria are as folows.
patients with irrecoverable renal failure
patients with irrecoverable liver failure
patients with respiratory failure without heart failure
patinets with severe bleeding tedency
small sized child patients
patients with allergy to metal

Target sample size

10


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Shunsuke Kawamoto

Organization

Tohoku University hospital

Division name

Cardiovascular Surgery

Zip code


Address

1-1, Seiryo-machi, Aoba-ku, Sendai, MIyagi, Japan

TEL

022-717-7222

Email

shunsukekawamoto@med.tohoku.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Shunsuke Kawamoto

Organization

Tohoku University hospital

Division name

Cardiovascular Surgery

Zip code


Address

1-1, Seiryo-machi, Aoba-ku, Sendai, MIyagi, Japan

TEL

022-717-7222

Homepage URL


Email

shunsukekawamoto@med.tohoku.ac.jp


Sponsor or person

Institute

Tohoku University Hospital

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


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

東北大学病院(宮城県)
Tohoku University Hospital (Miyagi prefecture)


Other administrative information

Date of disclosure of the study information

2016 Year 05 Month 23 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

2016 Year 10 Month 19 Day

Date of IRB


Anticipated trial start date

2016 Year 10 Month 19 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2016 Year 05 Month 17 Day

Last modified on

2019 Year 02 Month 05 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025747


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name