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
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
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
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
