UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038998 |
|---|---|
| Receipt number | 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 | 2021/12/06 09:58:33 |
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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
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
s.fukushima@ncvc.go.jp
Sponsor or person
Institute
National Cerebral and Cardiovascular Center
Institute
Department
Personal name
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
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
Completed
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
| 2021 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2021 | Year | 10 | Month | 18 | Day |
Date analysis concluded
| 2021 | Year | 11 | Month | 19 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 12 | Month | 25 | Day |
Last modified on
| 2021 | Year | 12 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044365
