Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000599471
Ethics application status
Approved
Date submitted
18/02/2025
Date registered
11/06/2025
Date last updated
11/06/2025
Date data sharing statement initially provided
11/06/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of Coseal on Left Ventricular Assist Device (LVAD) explantation during Heart Transplantation
Scientific title
Effect of Coseal at the time of durable left ventricular assist device implantation on the adhesions encountered at orthotopic heart transplantation
Secondary ID [1] 313799 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Adhesions during LVAD Explantation 336435 0
Condition category
Condition code
Cardiovascular 332956 332956 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention administered
- What it involves for participants; Coseal is a commercially available product which forms a hydrogel that inhibits adhesion formation that is applied during LVAD implantation. Participants will be randomised to treatment vs control group. Treatment group will receive coseal spray at the end of LVAD implantation vs control group will not. Both groups will then be assessed for adhesions at time of LVAD explant and heart transplantation. No other change in workup and follow up between the two groups.
- Frequency and duration of intervention: one spray application administered during LVAD implantation surgery. Dissolves within 30 days.
- Mode of administration: Spray applicator
- Who will be administering intervention: LVAD implanting cardiothoracic surgeon
- Strategies to monitor adherence: N/A
Intervention code [1] 330388 0
Treatment: Other
Comparator / control treatment
Current standard of care ie no coseal use during LVAD implantation
Control group
Active

Outcomes
Primary outcome [1] 340494 0
Adhesion severity
Timepoint [1] 340494 0
At LVAD explantation (approximately between 9-12 months post-coseal administration) – hard to give exact dates due to the unpredictable nature of heart transplantation
Secondary outcome [1] 444253 0
1) Time to commencement of cardiopulmonary bypass (CPB)
Timepoint [1] 444253 0
Intra op for time to commencement of CPB - during surgery for LVAD explantation and heart transplantation
Secondary outcome [2] 447998 0
2) Time to cardiectomy
Timepoint [2] 447998 0
Intra op for time to cardiectomy - during surgery for LVAD explantation and heart transplantation
Secondary outcome [3] 447999 0
Reexploration for bleeding and need for further coseal application
Timepoint [3] 447999 0
Over first 30 days since LVAD Implantation
Secondary outcome [4] 448469 0
Damage to cardiac or large vessels
Timepoint [4] 448469 0
Over first 30 days since LVAD Implantation
Secondary outcome [5] 448470 0
wound healing and infections
Timepoint [5] 448470 0
Over first 30 days since LVAD Implantation
Secondary outcome [6] 448471 0
Blood product usage
Timepoint [6] 448471 0
Over first 30 days since LVAD Implantation
Secondary outcome [7] 448472 0
Need for postoperative continuous renal replacement therapy (CRRT)
Timepoint [7] 448472 0
Over first 30 days since LVAD Implantation

Eligibility
Key inclusion criteria
All adult patients undergoing durable LVAD implant as bridge to transplantation
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Durable biventricular assist device (BiVAD) implant
Pump infection patients

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Descriptive statistics using SPSS package. For intergroup comparisons, Fisher’ exact test will be used for categorical variables, while Welch’s t-test or Wilcoxon’s rank sum test will be used for continuous variables

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
23/06/2025
Actual
Date of last participant enrolment
Anticipated
15/02/2027
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 27554 0
The Alfred - Melbourne
Recruitment postcode(s) [1] 43668 0
3004 - Melbourne

Funding & Sponsors
Funding source category [1] 318266 0
Commercial sector/Industry
Name [1] 318266 0
Baxter Health
Country [1] 318266 0
Australia
Primary sponsor type
Hospital
Name
Alfred Health
Address
Country
Australia
Secondary sponsor category [1] 320653 0
None
Name [1] 320653 0
Address [1] 320653 0
Country [1] 320653 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316906 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 316906 0
Ethics committee country [1] 316906 0
Australia
Date submitted for ethics approval [1] 316906 0
27/11/2024
Approval date [1] 316906 0
20/12/2024
Ethics approval number [1] 316906 0
770/24

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 139390 0
Mr Atsuo Doi
Address 139390 0
Alfred Health, 55 Commercial Road, Melbourne, VIC 3000
Country 139390 0
Australia
Phone 139390 0
+61 03 9076 3684
Fax 139390 0
Email 139390 0
[email protected]
Contact person for public queries
Name 139391 0
Atsuo Doi
Address 139391 0
Alfred Health, 55 Commercial Road, Melbourne, VIC 3000
Country 139391 0
Australia
Phone 139391 0
+61 03 9076 3684
Fax 139391 0
Email 139391 0
[email protected]
Contact person for scientific queries
Name 139392 0
Atsuo Doi
Address 139392 0
Alfred Health, 55 Commercial Road, Melbourne, VIC 3000
Country 139392 0
Australia
Phone 139392 0
+61 03 9076 3684
Fax 139392 0
Email 139392 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.