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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000035888
Receipt No. 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

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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
Email 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
Email tsutomu110.1965@gmail.com

Sponsor
Institute Keio University School of Medicine,
Department of Cardiovscular Surgery
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040825

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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