Trial Review

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The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12616000421437
Ethics application status
Approved
Date submitted
15/03/2016
Date registered
1/04/2016
Date last updated
1/04/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Troponin levels in patients undergoing spinal surgery:prone versus supine position.
Scientific title
Prospective controlled cohort study of Troponin I levels in patients undergoing spinal surgery: Prone versus supine position
Secondary ID [1] 288753 0
Nil Known
Universal Trial Number (UTN)
U1111-1180-7648
Trial acronym
TropoSS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
troponin elevation 298000 0
degenerative spine disorders undergoing a spinal surgical procedure 298001 0
Condition category
Condition code
Surgery 298153 298153 0 0
Other surgery
Cardiovascular 298154 298154 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
one
Target follow-up type
Months
Description of intervention(s) / exposure
Exposure is undergoing spinal surgery in the prone position for the duration of the operation, with blood samples taken up to 24 hours following surgery. Review of state-wide medical records at 30 days post surgery.
Intervention code [1] 294189 0
Not applicable
Comparator / control treatment
Supine spinal surgical position
Control group
Active

Outcomes
Primary outcome [1] 297665 0
serum troponin I level
Timepoint [1] 297665 0
Measurement taken prior to surgery, between zero and eight hours after surgery depending on clinician availability and between eight and twenty-four hours following surgery depending on clinician availability.
Secondary outcome [1] 321753 0
Mortality
Timepoint [1] 321753 0
Thirty-days post surgery
Secondary outcome [2] 321928 0
Any presentation to any public hospital with suspicion of a cardiovascular complaint. i.e requiring investigation with serum Troponin I levels, electrocardiogram and/or coronary angiogram. As identified on electronic medical record review.
Timepoint [2] 321928 0
thirty-days post surgery

Eligibility
Key inclusion criteria
All adult patients undergoing elective spinal surgery for degenerative conditions
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Paediatric population, oncologic surgery, emergency surgery

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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
5/04/2013
Date of last participant enrolment
Anticipated
Actual
20/11/2015
Date of last data collection
Anticipated
Actual
Sample size
Target
90
Accrual to date
Final
91
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 5431 0
The Townsville Hospital - Douglas
Recruitment postcode(s) [1] 12916 0
4814 - Douglas

Funding & Sponsors
Funding source category [1] 293110 0
Hospital
Name [1] 293110 0
The Townsville Hospital
Country [1] 293110 0
Australia
Primary sponsor type
Hospital
Name
The Townsville Hospital Neurosurgical Department
Address
100 Angus Smith Drive
Douglas
Queensland
4814
Country
Australia
Secondary sponsor category [1] 291899 0
None
Name [1] 291899 0
Address [1] 291899 0
Country [1] 291899 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294618 0
Townsville hospital and Health Service Human Research Ethics Comittee
Ethics committee address [1] 294618 0
100 Angus Smith Drive
Douglas QLD 4814
Ethics committee country [1] 294618 0
Australia
Date submitted for ethics approval [1] 294618 0
05/07/2012
Approval date [1] 294618 0
23/08/2012
Ethics approval number [1] 294618 0
HREC/12/QTHS/93

Summary
Brief summary
This is a novel study to determine if patients lying in the prone position for spinal surgery develop evidence of mild cardiac bruising as evidenced by a serial serum Troponin rise
and ECG abnormalities
We suspect that, after prolonged positioning in the prone position, some patients develop evidence of mild cardiac bruising. If so, we intend to study factors that may be
predictive of such cases. If confirmed, our study would indicate that all patients undergoing prone position spinal surgery should be consented for the possibility of developing cardiac bruising. If certain risk factors could be identified and if supine position
surgery was also simultaneously indicated, then the risk of cardiac bruising
would have to be evaluated in conjunction with other pros and cons of each approach, so that the individual could decide upon the best approach for their spinal surgery: i.e. anterior or posterior approach.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 64350 0
Dr Adam Ian Macfarlane
Address 64350 0
The Townsville Hospital
Department of Neurosurgery
100 Angus Smith Drive
Douglas
QLD
4814
Country 64350 0
Australia
Phone 64350 0
+61744331111
Fax 64350 0
Email 64350 0
[email protected]
Contact person for public queries
Name 64351 0
Laurence Marshman
Address 64351 0
The Townsville Hospital
Department of Neurosurgery
100 Angus Smith Drive
Douglas
QLD
4814
Country 64351 0
Australia
Phone 64351 0
+61744331111
Fax 64351 0
Email 64351 0
[email protected]
Contact person for scientific queries
Name 64352 0
Laurence Marshman
Address 64352 0
The Townsville Hospital
Department of Neurosurgery
100 Angus Smith Drive
Douglas
QLD
4814
Country 64352 0
Australia
Phone 64352 0
+61744331111
Fax 64352 0
Email 64352 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
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.