UMIN-CTR Clinical Trial

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