Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000707763
Ethics application status
Not yet submitted
Date submitted
20/06/2013
Date registered
28/06/2013
Date last updated
15/01/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
A Study to Evaluate the Use of GALA (Trademark), a Preservation Solution for Blood Vessels in Patients Undergoing Coronary Artery Bypass Graft Surgery.
Scientific title
A Study to Evaluate the short term clinical outcomes of GALA (Trademark) Vascular Conduit Preservation Solution in Patients Undergoing Coronary Artery Bypass Graft Surgery.
Secondary ID [1] 282713 0
Nil known
Universal Trial Number (UTN)
Trial acronym
GALA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Preservation of vein grafts in patients undergoing CABG (Coronary Artery Bypass Graft) Surgery 289427 0
Condition category
Condition code
Cardiovascular 289760 289760 0 0
Coronary heart disease
Surgery 289799 289799 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Saphenous vein harvesting will be uniformly performed using a standardised vein harvesting procedure. Harvested vein segments will be flushed and immersed in SOMVC001. After being stored in SOMVC001, vein segments will be grafted using standard surgical techniques.

SOMVC001 is a physiological salt solution containing Glutathione, Ascorbic Acid, and L-Arginine. SOMVC001 has nutrients for the cells as well as protective ingredients that can help the cells resist the damaging effects of prolonged storage.

Components of SOMVC001 solution:
i. Calcium chloride
ii. Potassium chloride
iii. Potassium phosphate (monobasic)
iv. Magnesium chloride (hexahydrate)
v. Magnesium sulfate (heptahydrate)
vi. Sodium chloride
vii. Sodium bicarbonate
viii. Sodium phosphate (dibasic; hepatahydrate)
ix. D-Dextrose
x. Glutathione (reduced)
xi. Ascorbic acid
xii. L-Arginine
xiii. Distilled water
Intervention code [1] 287374 0
Treatment: Other
Comparator / control treatment
No control - open label feasibility study
Control group
Uncontrolled

Outcomes
Primary outcome [1] 289842 0
The composite primary objective is to evaluate the short-term (30-day) outcomes of death or complications, perioperative myocardial infarction, perioperative cardiogenic shock, re-operation, ICU admission and hospital length of stay, re-admission occurring within 30 days after surgery or before discharge, whichever is later in patients undergoing first time CABG.
Timepoint [1] 289842 0
30 days
Secondary outcome [1] 303369 0
The secondary objective is to assess all adverse events through 30 days and evaluate them in respect to their relationship with the study product.
There are no current known adverse events associated with GALA. AEs are reported by the investigator via an electronic data capture system. AEs will be tabulated in the final report and narratives included where relevant.
Serious adverse events will be reported within 24 hours of awareness to the Medical Monitor who will adjudicate the event for required regulatory reporting.
Timepoint [1] 303369 0
30 days

Eligibility
Key inclusion criteria
*Adults age >18 to <75 years
*Patients undergoing first time elective or urgent CABG-only procedure
*Patients with at least 1 planned SVG
*Left ventricular ejection fraction (LVEF) >50%
*Female patients must be surgically sterile or postmenopausal
*Willingness, ability, and commitment to participate in a follow-up evaluation including a clinic visit at 30 days after the study procedure
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* In-situ IMA graft(s) only (no SVG)
* Prior CABG or planned concomitant valve surgery or aortic aneurysm repair
* Any clinically significant valve disease
* Left ventricular ejection fraction (LVEF) <50%
* Myocardial Infarction within 2 weeks of screening
* Creatinine >177 micro mol/l
* Vasculitis or another nonatherosclerotic cause of CAD
* Hypercoagulable state
* Any condition or disease detected that would render the patient unsuitable for the study
* Involvement in another drug or device study within 30 days
* Inability of the patient to provide informed consent

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Open label for patients undergoing CABG who provide informed consent to participate and meet the eligibility criteria
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
NA
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
NONE
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis
This is an open-label study and no hypothesis testing will be performed. Data will be summarized descriptively, both overall and by descriptive statistics for all demographic, baseline and surgical characteristics of all variables. Categorical data will be summarized by counts and percentages. All adverse events will be displayed on listings and tables.

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
Sponsors decision.
Date of first participant enrolment
Anticipated
1/08/2013
Actual
Date of last participant enrolment
Anticipated
31/12/2013
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
25
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 1144 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy

Funding & Sponsors
Funding source category [1] 287482 0
Commercial sector/Industry
Name [1] 287482 0
Somhlution Inc
Country [1] 287482 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Mobius Medical Pty Ltd
Address
Level 32
1 Market St
Sydney NSW 2000
Country
Australia
Secondary sponsor category [1] 286224 0
None
Name [1] 286224 0
Address [1] 286224 0
Country [1] 286224 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 289460 0
HREC D
Ethics committee address [1] 289460 0
Research Governance Unit,
Level 5,
Mary Aikenhead Building
27 Victoria Parade
Fitzroy
VIC 3065
Ethics committee country [1] 289460 0
Australia
Date submitted for ethics approval [1] 289460 0
24/06/2013
Approval date [1] 289460 0
Ethics approval number [1] 289460 0

Summary
Brief summary
Participants are invited to take part in this research project if they are undergoing a coronary artery bypass graft surgery (CABG). During the surgery, blood vessels from other parts of the body will be used to ‘bypass’ blocked blood vessels in the heart which will improve the blood flow to the heart muscle. When blood vessels are removed from the body they must be immersed in a solution (salts in water) to keep them healthy before until they are replaced onto the heart. This research project is testing a new solution known as SOMVC001 (also known as GALA), which is intended to improve the preservation of the blood vessels, which are removed during the operation until they are placed on the heart.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 40946 0
Mr Michael Yii
Address 40946 0
Cardiothoracic Surgery
Level 1
St Vincent's Hospital
41 Victoria Parade
Fitzroy
VIC 3065
Country 40946 0
Australia
Phone 40946 0
+61 3 9288 4615
Fax 40946 0
+61 3 9288 4616
Email 40946 0
[email protected]
Contact person for public queries
Name 40947 0
Mrs Jane Mack
Address 40947 0
Cardiothoracic Surgery
Level 1
St Vincent's Hospital
41 Victoria Parade
Fitzroy
VIC 3065
Country 40947 0
Australia
Phone 40947 0
+61 3 9288 4615
Fax 40947 0
+61 3 9288 4616
Email 40947 0
[email protected]
Contact person for scientific queries
Name 40948 0
Mr Michael Yii
Address 40948 0
Cardiothoracic Surgery
Level 1
St Vincent's Hospital
41 Victoria Parade
Fitzroy
VIC 3065
Country 40948 0
Australia
Phone 40948 0
+61 3 9288 4615
Fax 40948 0
+61 3 9288 4616
Email 40948 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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Documents added automatically
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