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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000038998
Receipt No. R000044365
Scientific Title A multicenter, randomized, parallel-group study to assess the safety and efficacy of adhesion prevention device, BAX 602, in preventing adhesion of heart and great vessels to surroundings after placement of extracorporeal ventricular assist device (VAD)
Date of disclosure of the study information 2020/01/06
Last modified on 2020/01/07

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Basic information
Public title A multicenter, randomized, parallel-group study to assess the safety and
efficacy of adhesion prevention device, BAX 602, in preventing adhesion of
heart and great vessels to surroundings after placement of extracorporeal
ventricular assist device (VAD)
Acronym Adhesion prevention device "BAX602"
Scientific Title A multicenter, randomized, parallel-group study to assess the safety and
efficacy of adhesion prevention device, BAX 602, in preventing adhesion of
heart and great vessels to surroundings after placement of extracorporeal
ventricular assist device (VAD)
Scientific Title:Acronym NCVC-BAX602
Region
Japan

Condition
Condition Patients undergoing open surgery for VAD placement to treat acute circulatory failure, who fulfill all the inclusion and exclusion criteria at the time of enrollment will be enrolled as eligible patients.
Classification by specialty
Cardiovascular surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Is BAX 602 effective for prevention of adhesion when applied on the surface of the heart and great vessels in patients undergoing open surgery for VAD placement to treat cardiogenic circulatory failure?
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase II,III

Assessment
Primary outcomes Severity of adhesion between the surface of the heart/great vessels and surrounding tissues.
Key secondary outcomes 1) Survival
2) Re-thoracotomy for hemostasis after primary thoracotomy
3) Volume of blood transfused during re-thoracotomy
4) Absence of mediastinitis requiring surgical intervention

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as a block.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 In patients assigned to the study treatment group, all 8 mL of BAX 602 will be evenly sprayed over the surface of the heart and great vessels, using a Spray Set, after placement of an extracorporeal VAD and before closing the chest. After confirmation that all the quantity has been sprayed, the chest will be closed.

Interventions/Control_2 In patients assigned to the study control group, the chest will be simply closed after placement of an extracorporeal VAD.
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
12 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria 1) Patient aged between 12 years and 79 years when providing informed consent
2) Patient to receive an extracorporeal VAD to treat acute congestive cardiac failure
3) Patient or legal representative/close relative has provided written informed consent
Key exclusion criteria 1) Patient falling under either of the contraindications of the study device
2) Patient that is participating or is scheduled to participate during the course of this study in any clinical study involving an investigational product
3) Patient ineligible for participation in this study in the judgment of the Investigator/Subinvestigator
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Tomoyuki
Middle name
Last name Fujita
Organization National Cerebral and Cardiovascular Center
Division name Cardiac Surgery
Zip code 564-8565
Address 6-1 Kishibeshimmachi, Suita, Osaka
TEL 06-6170-1070
Email tfujita@ncvc.go.jp

Public contact
Name of contact person
1st name Satsuki
Middle name
Last name Fukushima
Organization National Cerebral and Cardiovascular Center
Division name Cardiac Surgery
Zip code 564-8565
Address 6-1 Kishibeshimmachi, Suita, Osaka
TEL 06-6170-1070
Homepage URL
Email s.fukushima@ncvc.go.jp

Sponsor
Institute National Cerebral and Cardiovascular Center
Institute
Department

Funding Source
Organization Baxter Healthcare Corporation
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization National Cerebral and Cardiovascular Center
Address 6-1 Kishibeshimmachi, Suita, Osaka
Tel 06-6170-1070
Email matsumura.narumi.hp@ncvc.go.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 東京大学病院、九州大学病院

Other administrative information
Date of disclosure of the study information
2020 Year 01 Month 06 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 Open public recruiting
Date of protocol fixation
2019 Year 10 Month 01 Day
Date of IRB
2019 Year 10 Month 28 Day
Anticipated trial start date
2020 Year 01 Month 06 Day
Last follow-up date
2021 Year 05 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 12 Month 25 Day
Last modified on
2020 Year 01 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044365

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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