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Trial registered on ANZCTR
Registration number
ACTRN12619000621112
Ethics application status
Approved
Date submitted
13/12/2018
Date registered
26/04/2019
Date last updated
7/09/2021
Date data sharing statement initially provided
26/04/2019
Type of registration
Prospectively registered
Titles & IDs
Public title
A study of the local anaesthetic lidocaine and the antibiotic doxycycline to help protect the blood vessel lining in patients undergoing heart surgery.
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Scientific title
Preserving the endothelial glycocalyx in patients undergoing cardiopulmonary bypass. A prospective randomised interventional pilot study of doxycycline and lidocaine.
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Secondary ID [1]
296877
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None
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Universal Trial Number (UTN)
U1111-1225-5165
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Trial acronym
LiDEG
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Ischaemic Heart Disease
310803
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Valvular Heart Disease
310804
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Aortic Disease
310805
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Condition category
Condition code
Anaesthesiology
309478
309478
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0
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Anaesthetics
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Cardiovascular
309479
309479
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0
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Coronary heart disease
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Cardiovascular
309480
309480
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0
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Diseases of the vasculature and circulation including the lymphatic system
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Cardiovascular
309481
309481
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0
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Other cardiovascular diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Participants, patients undergoing elective or urgent surgery requiring cardiopulmonary bypass, will be randomised to 1 of 3 equal groups. The groups consist of a control group, a group receiving intravenous lidocaine (1.5mg/kg bolus followed by 2mg/kg/hr infusion) during their operation, a group receiving oral doxycycline (200mg tablet) in the holding bay 0-90mins prior to being brought into theatre.
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Intervention code [1]
313154
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Treatment: Drugs
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Comparator / control treatment
A group will receive neither treatment and their samples will be used as the control.
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Control group
Active
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Outcomes
Primary outcome [1]
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Change in syndecan-1 (Biochemical marker of endothelial glycocalyx injury).
Expressed as a fold increase of baseline (pre-induction) level.
Assessed by serial serum assays.
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Assessment method [1]
308440
0
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Timepoint [1]
308440
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Serial measurements,
1. pre induction through invasive monitoring line.
2. after protamine administration (heparin reversal after end of cardiopulmonary bypass)
3. admission to ICU
4. 6 hours post operatively.
5. First post operative morning
(Prior work has a peak at 6 hours with diminishing levels observed by the morning of day 1 post op)
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Secondary outcome [1]
354961
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Vasopressor (blood pressure support) requirements. (Dose of noradrenaline measured in micrograms per minute)
This information is automatically recorded from "smart" infusion pumps and is available from the electronic record in ICU
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Assessment method [1]
354961
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Timepoint [1]
354961
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Requirement and agent immediately after arrival in ICU and
Requirement at 6 hours post operatively
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Secondary outcome [2]
354962
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Presence or absence of atrial fibrillation
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Assessment method [2]
354962
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Timepoint [2]
354962
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90 days post operatively
This is already routinely screened for and recorded in the electronic notes in all patients
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Secondary outcome [3]
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Incidence of chronic post surgical pain
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Assessment method [3]
354963
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Timepoint [3]
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90 days post operatively. via telephone.
"QoR 15" quality of recovery
study-specific questionnaire
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Secondary outcome [4]
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Kidney dysfunction
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Assessment method [4]
354964
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Timepoint [4]
354964
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maximum serum creatinine recording within 72 hours post operatively expressed as a fold increase of baseline creatinine.
or
New renal replacement therapy within 72 hours of operation
All info routinely recorded in all patients
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Secondary outcome [5]
354965
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inflammation. Cytokine interleukin 6
Expressed as a fold increase of baseline (pre-induction) level.
Assessed by serial serum assays.
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Assessment method [5]
354965
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Timepoint [5]
354965
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Serial measurements,
1. pre induction through invasive monitoring line.
2. after protamine administration (heparin reversal after end of cardiopulmonary bypass)
3. admission to ICU
4. 6 hours post operatively.
5. First post operative morning
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Secondary outcome [6]
354966
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Bleeding- Volume in combined pleural and pericardial drains (drain from common tube)
Expressed in millilitres
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Assessment method [6]
354966
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Timepoint [6]
354966
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total 12 hour post operative volume
routinely measured in all patients and recorded in electronic record
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Secondary outcome [7]
368153
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Use of red cell transfusion
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Assessment method [7]
368153
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Timepoint [7]
368153
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Within 72 hours of operation. Including intraoperative transfusion.
Routinely recorded.
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Secondary outcome [8]
368155
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Use of any non red cell blood products (any of fresh frozen plasma, platelets, prothrombin complex)
(indicates coagulation disorders)
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Assessment method [8]
368155
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Timepoint [8]
368155
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Within 72 hours of operation. Including intraoperative use.
Routinely recorded.
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Secondary outcome [9]
368156
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inflammation. Cytokine interleukin 8
Expressed as a fold increase of baseline (pre-induction) level.
Assessed by serial serum assays.
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Assessment method [9]
368156
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Timepoint [9]
368156
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Serial measurements,
1. pre induction through invasive monitoring line.
2. after protamine administration (heparin reversal after end of cardiopulmonary bypass)
3. admission to ICU
4. 6 hours post operatively.
5. First post operative morning
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Secondary outcome [10]
368158
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total White cell count
Expressed as a fold increase of baseline (pre-induction) level.
Assessed by serial serum assays.
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Assessment method [10]
368158
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Timepoint [10]
368158
0
Serial measurements,
1. pre induction through invasive monitoring line.
2. after protamine administration (heparin reversal after end of cardiopulmonary bypass)
3. admission to ICU
4. 6 hours post operatively.
5. First post operative morning
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Eligibility
Key inclusion criteria
All adult patients with capacity to consent undergoing operations requiring cardiopulmonary bypass.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Unable to consent/ refusal.
Hypersensitivity to study drugs.
Operations not requiring cardiopulmonary bypass.
Known or suspected liver disease
Alcoholism
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
3 equal groups of 20 (totalling 60) will be written on paper concealed in opaque envelopes.
This will then be broken into 5 bundles of 12 (with 4 from each of the 3 treatment arms).
Envelopes within each bundle will then be shuffled repeatedly to ensure randomisation.
This technique is to facilitate interim analysis with equal numbers from each group represented.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Factorial
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Other design features
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Phase
Phase 4
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
Comparisons will be made using means paired analyses, computed with “PRISM” statistical software. Being a pilot we are in the hypothesis generating phase and have not performed power analysis.
It will be analysed using a "per protocol" approach.
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
1/07/2019
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Actual
3/02/2020
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Date of last participant enrolment
Anticipated
1/03/2022
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Actual
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Date of last data collection
Anticipated
31/08/2022
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Actual
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Sample size
Target
60
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Accrual to date
31
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Final
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Recruitment in Australia
Recruitment state(s)
WA
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Recruitment hospital [1]
12723
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Fiona Stanley Hospital - Murdoch
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Recruitment hospital [2]
12724
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Mount Hospital - Perth
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Recruitment postcode(s) [1]
25150
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6150 - Murdoch
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Recruitment postcode(s) [2]
25151
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6000 - Perth
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Funding & Sponsors
Funding source category [1]
301446
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Charities/Societies/Foundations
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Name [1]
301446
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Spinnaker Foundation
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Address [1]
301446
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Alma Street, Room Fremantle Hospital Alma Street, Room 27B, G Block27B, G Block, Fremantle WA 6160
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Country [1]
301446
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Australia
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Primary sponsor type
Charities/Societies/Foundations
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Name
Hearty and Lung Institute of Western Australia
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Address
Care of: Dept of Anaesthesia (Cardiothoracic division)
Fiona Stanley Hospital
11 Robin Warren Dr,
Murdoch
WA 6150
Australia
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Country
Australia
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Secondary sponsor category [1]
301137
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Hospital
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Name [1]
301137
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Fiona Stanley hospital
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Address [1]
301137
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11 Robin Warren Dr, Murdoch WA 6150
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Country [1]
301137
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
302181
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South Metropolitan Health Service Human Research Ethics Committee
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Ethics committee address [1]
302181
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Fiona Stanley Hospital, 11 Robin Warren Dr, Murdoch WA 6150
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Ethics committee country [1]
302181
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Australia
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Date submitted for ethics approval [1]
302181
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25/03/2019
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Approval date [1]
302181
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03/05/2019
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Ethics approval number [1]
302181
0
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Summary
Brief summary
Heart surgery is known to cause damage to the inner lining of blood vessels called the "endothelial glycocalyx". This damage can affect bleeding, swelling and inflammation which can harm organs and delay recovery after surgery. Damage to this layer can be measured using special blood tests. Currently there are no drugs used to protect this layer during surgery. Some experiments have shown the commonly used local anaesthetic "lidocaine" and the antibiotic "doxycycline" may be of benefit to protect this layer. We propose a project in which patients undergoing heart surgery are randomly allocated to receive one or other of the medicines or neither (a "control" group). Blood tests will indicate if these medicines have an effect on this layer. We hypothesise that lidocaine and or doxycycline may protect the endothelial glycocalyx during heart surgery.
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Trial website
NA
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Trial related presentations / publications
NA
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Public notes
NA
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Contacts
Principal investigator
Name
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Dr Mark Johnson
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Address
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Dept. of Anaesthesia,
Fiona Stanley Hospital,
11 Robin Warren Dr, Murdoch WA 6150
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Country
89394
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Australia
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Phone
89394
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+61 474190065
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Fax
89394
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Email
89394
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[email protected]
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Contact person for public queries
Name
89395
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Dr Mark Johnson
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Address
89395
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Dept. of Anaesthesia,
Fiona Stanley Hospital,
11 Robin Warren Dr, Murdoch WA 6150
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Country
89395
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Australia
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Phone
89395
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+61 474190065
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Fax
89395
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Email
89395
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[email protected]
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Contact person for scientific queries
Name
89396
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Dr Mark Johnson
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Address
89396
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Dept. of Anaesthesia,
Fiona Stanley Hospital,
11 Robin Warren Dr, Murdoch WA 6150
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Country
89396
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Australia
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Phone
89396
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+61 474190065
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Fax
89396
0
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Email
89396
0
[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
Not required. Data will be analysed by group.
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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.
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