Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000183280
Ethics application status
Approved
Date submitted
24/02/2009
Date registered
17/04/2009
Date last updated
5/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
The influence of differing inspired oxygen concentrations on platelet function in a model of ischaemic reperfusion injury
Scientific title
A trial of patients with an upper limb arterial tournique and whether an increase in inspired oxygen concentration at the time of reperfusion has any effect on platelet activation, as assessed by flow cytometry and thromboelastography
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ischaemic reperfusion injuries 4623 0
Condition category
Condition code
Blood 4618 4618 0 0
Clotting disorders
Anaesthesiology 4619 4619 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Increasing the fractional inspired oxygen concentration to 0.5 and 0.8 from 0.3 at the time of reperfusion. This is achieved by altering oxygen concentration on the ventilator. This is a one off treatment started 10 minutes before tourniquet release and continued until 30 minutes after tourniquet release.
Intervention code [1] 4105 0
Treatment: Other
Comparator / control treatment
Keeping the fractional inspired oxygen concentration at 0.3 at the time of reperfusion. This is a one off treatment started 10 minutes before tourniquet release and continued until 30 minutes after tourniquet release.
Control group
Dose comparison

Outcomes
Primary outcome [1] 5491 0
Change in platelet activation as assessed by flow cytometry (degree of change unknown)
Timepoint [1] 5491 0
pre induction, 10 mins pre tourniquet deflation, immediately pre tourniquet deflation, 5 mins post tourniquet and 30 mins post tourniquet deflation
Secondary outcome [1] 9250 0
Change in platelet activation as assessed by thromboelastography (degree of change unknown)
Timepoint [1] 9250 0
pre induction, 10 mins pre tourniquet deflation, immediately pre tourniquet deflation, 5 mins post tourniquet and 30 mins post tourniquet deflation

Eligibility
Key inclusion criteria
1. Adult patients undergoing upper limb surgery that requires the use of a tourniquet for more than 45 minutes
2. American Society of Anaesthesiology (ASA) grade 1 or 2
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients taking any antiplatelet medication
2. Confirmed coagulation disorder (pathological or drug induced)
3. Platelet count less then 80 x 109/l
4. Blood urea greater than 8.0 mmol/L
5. Systemic infection
6. Confirmed systemic Inflammatory diseases
7. Documented pregnancy
8. Documented malignancy
9. Trauma other than the ipsilateral upper limb
10. Multiple tourniquet episodes
11. Likely intraoperative O2 requirement > 30%

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)
Identified from theatre lists. Written informed consent as per ethical guidelines. Allocation concealment by sealed opaque envelopes. Patients blinded to intervention.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random number generator using computerised sequence generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
23/03/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
45
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4548 0
Charities/Societies/Foundations
Name [1] 4548 0
Royal Perth Hospital Medical Research Fundation
Country [1] 4548 0
Australia
Primary sponsor type
Hospital
Name
Royal Perth Hospital
Address
Royal Perth Hospital,
Wellington street Campus,
Perth 6000
WA
Country
Australia
Secondary sponsor category [1] 4104 0
None
Name [1] 4104 0
Address [1] 4104 0
Country [1] 4104 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6851 0
Royal Perth Ethics Committee
Ethics committee address [1] 6851 0
Royal Perth Hospital,
Wellington street Campus,
Perth 6000
WA
Ethics committee country [1] 6851 0
Australia
Date submitted for ethics approval [1] 6851 0
Approval date [1] 6851 0
05/12/2008
Ethics approval number [1] 6851 0
EC 2008/200

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

Contacts
Principal investigator
Name 29316 0
Address 29316 0
Country 29316 0
Phone 29316 0
Fax 29316 0
Email 29316 0
Contact person for public queries
Name 12563 0
Dr Thomas Collyer
Address 12563 0
Department of anaesthesia
Royal Perth Hospital,
Wellington street Campus,
Perth 6000
WA
Country 12563 0
Australia
Phone 12563 0
+61 (8) 93843517
Fax 12563 0
Email 12563 0
[email protected]
Contact person for scientific queries
Name 3491 0
Dr Thomas Collyer
Address 3491 0
Department of anaesthesia
Royal Perth Hospital,
Wellington street Campus,
Perth 6000
WA
Country 3491 0
Australia
Phone 3491 0
+61 (8) 93843517
Fax 3491 0
Email 3491 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.