Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000286842
Ethics application status
Not yet submitted
Date submitted
9/03/2012
Date registered
12/03/2012
Date last updated
12/03/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
VALDA: Volatile Associated Liver Disease Audit
Scientific title
A Prospective Study of The Incidence of Liver Injury Caused by Volatile Anaesthesia In Trauma Patients Undergoing Surgery
Secondary ID [1] 280099 0
Nil
Universal Trial Number (UTN)
U1111-1128-9973
Trial acronym
V.A.L.D.A.
Linked study record

Health condition
Health condition(s) or problem(s) studied:
The incidence of liver disease caused by exposure to volatile anaesthetic agents, in trauma patients. 286012 0
Condition category
Condition code
Anaesthesiology 286198 286198 0 0
Anaesthetics
Oral and Gastrointestinal 286199 286199 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Inflammatory and Immune System 286200 286200 0 0
Allergies

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Trauma patients admitted and undergoing surgical procedures will have their liver function assessed during admission to ascertain the development of liver disease, potentially resulting from exposure to volatile anaesthetic agents. VALDA occurs typically within days of exposure, and therefore patients will have repeat LFTs taken on admission, and then on days 1, 4, 8 and 12 postoperatively. Those with a characteristic pattern of dysfunction will be followed up with immunoassay, to confirm the development and presence of antibodies typically seen in immune-mediated liver dysfunction (anti-trifluoroactate [TFA] antibodies). Those with abnormal liver function will be followed up by a hepatologist.
Intervention code [1] 284424 0
Not applicable
Comparator / control treatment
Trauma patients admitted, but having no surgery, and
trauma patients undergoing surgery with no volatile exposure (TIVA or regional technique) will have their liver function assessed.
Control group
Active

Outcomes
Primary outcome [1] 286674 0
Incidence of liver disease attributable to volatile agent exposure, as determined by previously mentioned data. Patients with abnormal over function will be further for concomitant hepatotoxic medications and liver injury. Those suspicious of VALDA will have anti-TFA antibody screening to confirm it.
Timepoint [1] 286674 0
Development of VALDA within 12 days of exposure.
Secondary outcome [1] 296443 0
Incidence of liver disease in trauma patients, as determined by abnormal liver function tests.
Timepoint [1] 296443 0
Within twelve days of surgery.

Eligibility
Key inclusion criteria
Trauma patients admitted to Royal Melbourne Hospital.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No consent.

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/04/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 284855 0
Self funded/Unfunded
Name [1] 284855 0
Country [1] 284855 0
Australia
Primary sponsor type
Individual
Name
Brad Hockey
Address
c/- Department of Anaesthesia and Pain Management
Royal Melbourne Hospital
Grattan St, Melbourne VIC 3050
Country
Australia
Secondary sponsor category [1] 283733 0
None
Name [1] 283733 0
Address [1] 283733 0
Country [1] 283733 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 286843 0
Melbourne Health Human Research Ethics Committee (EC00243)
Ethics committee address [1] 286843 0
Ethics committee country [1] 286843 0
Australia
Date submitted for ethics approval [1] 286843 0
09/02/2012
Approval date [1] 286843 0
Ethics approval number [1] 286843 0
2012.009

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

Contacts
Principal investigator
Name 33883 0
Address 33883 0
Country 33883 0
Phone 33883 0
Fax 33883 0
Email 33883 0
Contact person for public queries
Name 17130 0
Dr Brad Hockey
Address 17130 0
c/- Department of Anaesthesia and Pain Management
3 North, Royal Melbourne Hospital
Grattan St, Melbourne
VIC 3050
Country 17130 0
Australia
Phone 17130 0
+61393427540
Fax 17130 0
+61393428623
Email 17130 0
brad.hockey@mh.org.au
Contact person for scientific queries
Name 8058 0
Dr Brad Hockey
Address 8058 0
c/- Department of Anaesthesia and Pain Management
3 North, Royal Melbourne Hospital
Grattan St Melbourne
VIC 3050
Country 8058 0
Australia
Phone 8058 0
+61393427540
Fax 8058 0
+61393428623
Email 8058 0
brad.hockey@mh.org.au

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
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.