UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035888 |
|---|---|
| Receipt number | R000040825 |
| Scientific Title | Single-center, unblinded, randomized comparison study between new cardiopulmonary bypass circuit "Oxia N" and existing circuit. |
| Date of disclosure of the study information | 2019/02/21 |
| Last modified on | 2019/06/14 12:45:52 |
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Basic information
Public title
Single-center, unblinded, randomized comparison study between new cardiopulmonary bypass circuit "Oxia N" and existing circuit.
Acronym
Single-center, unblinded, randomized comparison study between new cardiopulmonary bypass circuit "Oxia N" and existing circuit.
Scientific Title
Single-center, unblinded, randomized comparison study between new cardiopulmonary bypass circuit "Oxia N" and existing circuit.
Scientific Title:Acronym
Single-center, unblinded, randomized comparison study between new cardiopulmonary bypass circuit "Oxia N" and existing circuit.
Region
| Japan |
Condition
Condition
aortic arch aneurysm
Classification by specialty
| Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
It is aimed to conduct comparative study on biocompatibility due to difference in coating at the time of clinical use of artificial cardiopulmonary circuit manufactured by JMS Co., Ltd.
Focus on the adhesion status of "blood protein", "inflammatory marker", and "blood cell component" to the product surface.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Protein in blood, inflammatory marker, coagulation marker are measured at the following 6 points. That is, before the start of extracorporeal circulation, immediately after the start of extracorporeal circulation, 60 minutes after extracorporeal circulation, at the end of extracorporeal circulation, 120 minutes after extracorporeal circulation, after the first sickness day.
Key secondary outcomes
SEM observation
Regarding products such as artificial lung, centrifugal pump etc. after extracorporeal circulation
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Intervention group: Pre-connect circuit manufactured by JMS Inc. is used during aortic arch surgery (artificial lung, centrifugal pump, main circuit with MPC coating)
Interventions/Control_2
Control group: Pre-connect circuit manufactured by JMS Co., Ltd. is used during aortic arch surgery (artificial lung, centrifugal pump, main circuit with heparin coating)
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 for aortic arch surgery, limited to initial surgery, who weigh 50 to 80 kg, only when it is judged that the blood flow rate during surgery is not more than the maximum flow rate (7 L / min) of each product.
Key exclusion criteria
Patients who are judged that clinical evaluation can not be performed properly, depending on the judgment of the attending surgeon.
(renal dysfunction, liver dysfunction, diabetes, anticoagulation disorder, malignant tumor, autoimmune disease etc.)
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hideyuki Shimizu |
Organization
Keio University School of Medicine
Division name
Department of Cardiovscular Surgery
Zip code
Address
35 Shinanomachi,Shinjuku-ku,Tokyo
TEL
03-3353-1211
shimizu.md@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tsutomu Ito |
Organization
Keio University School of Medicine
Division name
Department of Cardiovscular Surgery
Zip code
Address
35 Shinanomachi,Shinjuku-ku,Tokyo
TEL
03-3353-1211
Homepage URL
tsutomu110.1965@gmail.com
Sponsor or person
Institute
Keio University School of Medicine,
Department of Cardiovscular Surgery
Institute
Department
Personal name
Funding Source
Organization
JMS Co.,LTD.
Development Department,Surgical & Therapeutical Business Unit
Organization
Division
Category of Funding Organization
Profit organization
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
慶應義塾大学病院（東京都）/ Keio University Hospital(Tokyo)
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 02 | Month | 21 | 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 | 04 | Month | 12 | Day |
Date of IRB
| 2019 | Year | 02 | Month | 22 | Day |
Anticipated trial start date
| 2018 | Year | 01 | Month | 24 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 02 | Month | 15 | Day |
Last modified on
| 2019 | Year | 06 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040825
