Trial from ANZCTR


Trial ID ACTRN12605000009617
Trial Status: Registered
Date Submitted: 12/07/2005
Date Registered: 14/07/2005
Retrospectively registered

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Public title The DECRA trial
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Study title in 'Participant- Intervention- Comparator- Outcome (PICO)' format Multi-centre randomised trial to evaluate the effect of early decompressive craniectomy on neurological function in patients with severe traumatic brain injury
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UTN
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Trial acronym DECRA
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Health condition(s) or problem(s) studied:
Severe diffuse traumatic brain injury with refractory intracranial hypertension 71 0
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Condition category: Condition code:
Neurological Other neurological disorders
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83 83 0 0
Neurological Other injuries and accidents
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84 84 0 0

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Descriptions of intervention(s) / exposure Early decompressive craniectomy
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Intervention Code:
Treatment: surgery 14 0
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Comparator / control treatment Best current medical management
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Control group Active
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Primary Outcome: Neurological function using the Glasgow Outcome Score. Neurological function is quantified as proportion of favourable outcomes (GOSE grades 5-8) 115 0
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Timepoint: Measured at 6 months post injury 115 0
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Secondary Outcome: Mean and maximum hourly ICP. 264 0
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Timepoint: 72HRS POST RANDOMISATION 264 0
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Secondary Outcome: Favourable outcomes (GOSE 5-8). 265 0
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Timepoint: At 12 months post injury. 265 0
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Secondary Outcome: Mean GOSE 266 0
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Timepoint: At 6 and 12 months using ordinal logistic regression. 266 0
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Secondary Outcome: Mortality 267 0
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Timepoint: hospital 6 months, 12 months 267 0
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Secondary Outcome: Days in ICU and hospital 268 0
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Timepoint: ICU discharge, Hospital discharge 268 0
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Secondary Outcome: Brain metabolites using microdialysis (The Alfred only). 269 0
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Timepoint: ICU admission 269 0
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Key inclusion criteria First 72 hours from time of injury-Severe diffuse traumatic brain injury-ICP monitor in-situ -Refractory intracranial hypertension
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Minimum age 15 Years
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Maximum age 60 Years
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Gender Both males and females
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Healthy volunteers? No
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Key exclusion criteria Mass lesion>3cm-EDH/SDH>0.5cm or requiring evacuation-Spinal cord injury-Penetrating brain injury-Cardiac arrest at scene-Fixed dilated pupils and GCS=3-Neurosurgery contraindicated-No chance of survival after review of CT brain scan and clinical findings (Neurosurgeon decision).
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Study type Interventional
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Purpose of the study Treatment
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Allocation to intervention Randomised controlled trial
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Describe the procedure for enrolling a subject and allocating the treatment (allocation concealment procedures) Automated telephone allocation/randomisation
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Describe the methods used to generate the sequence in which subjects will be randomised (sequence generation) The random allocation sequence will be generated by a computer program (StataCorp. Stata Statistical Software release 8.0) Randomisation will be in variable block sizes. Randomisation will be stratified first by centre and secondly by EVD presence
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Masking / blinding Open (masking not used)
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Who is / are masked / blinded (choose all that apply)


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Assignment Parallel
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Other design features
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Type of endpoint(s) Efficacy
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Statistical Methods/Analysis
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Phase Phase 3
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Anticipated date of first participant enrolment 1/08/2003
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Date of first participant enrolment
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Anticipated date last participant recruited/enrolled
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Actual date last participant recruited/enrolled
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Target sample size 165
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Recruitment status Recruiting
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Recruitment in Australia

Recruitment state(s)
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Recruitment outside Australia

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Funding Source: Government body 119 0
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Name: National Health & Medical Research Council 119 0
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Address: National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601
119 0
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Country: Australia 119 0
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Funding Source: Charities/Societies/Foundations 120 0
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Name: Victorian Trauma Foundation 120 0
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Address: Level 19, 222 Exhibition St.
Melbourne VIC 3000
Australia
120 0
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Country: Australia 120 0
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Funding Source: Charities/Societies/Foundations 121 0
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Name: ANZ Intensive Care Foundation 121 0
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Address: Level 2, 10 Ievers Terrace
Carlton, Victoria 3053, Australia
121 0
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Country: Australia 121 0
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Funding Source: Charities/Societies/Foundations 122 0
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Name: WA Institute for Medical Research 122 0
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Address: Level 5 & 6, MRF Building
Rear 50 Murray Street
PERTH WA 6000
122 0
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Country: Australia 122 0
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Funding Source: Charities/Societies/Foundations 3752 0
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Name: Victorian Neurotrauma Initiative 3752 0
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Address: Level 19, 222 Exhibition St.
Melbourne VIC 3000
3752 0
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Country: Australia 3752 0
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Primary Sponsor Other
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Name: National Trauma Research Institute, The Alfred
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Address: 89 Commercial Rd
Melbourne, Vic, 3004
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Country: Australia
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Secondary Sponsor: None 88 0
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Name: Nil 88 0
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Address: 88 0
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Country: 88 0
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Has the study received approval from at least one Ethics Committee? Yes
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Ethics Committee name: The Alfred Hospital 856 0
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Address: Commercial Rd
Melbourne, Vic, 3004
856 0
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Country: Australia 856 0
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Approval Date: 856 0
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Submitted Date: 856 0
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HREC: 856 0
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Ethics Committee name: Royal Melbourne Hospital 857 0
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Address: 857 0
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Country: Australia 857 0
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Approval Date: 857 0
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Submitted Date: 857 0
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HREC: 857 0
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Ethics Committee name: Royal Adelaide Hospital 858 0
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Address: 858 0
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Country: Australia 858 0
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Approval Date: 858 0
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Submitted Date: 858 0
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HREC: 858 0
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Ethics Committee name: Royal Perth Hospital 859 0
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Address: 859 0
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Country: Australia 859 0
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Approval Date: 859 0
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Submitted Date: 859 0
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HREC: 859 0
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Ethics Committee name: Sir Charles Gairdner Hospial 860 0
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Address: 860 0
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Country: Australia 860 0
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Approval Date: 860 0
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Submitted Date: 860 0
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HREC: 860 0
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Ethics Committee name: Royal North Shore Hospital 861 0
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Address: 861 0
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Country: Australia 861 0
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Approval Date: 861 0
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Submitted Date: 861 0
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HREC: 861 0
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Ethics Committee name: John Hunter Hospital 862 0
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Address: 862 0
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Country: Australia 862 0
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Approval Date: 862 0
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Submitted Date: 862 0
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HREC: 862 0
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Ethics Committee name: Nepean Hospital 863 0
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Address: 863 0
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Country: Australia 863 0
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Approval Date: 863 0
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Submitted Date: 863 0
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HREC: 863 0
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Ethics Committee name: Liverpool Hospital 864 0
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Address: 864 0
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Country: Australia 864 0
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Approval Date: 864 0
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Submitted Date: 864 0
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HREC: 864 0
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Ethics Committee name: Westmead Hospital 865 0
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Address: 865 0
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Country: Australia 865 0
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Approval Date: 865 0
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Submitted Date: 865 0
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HREC: 865 0
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Ethics Committee name: Gold Coast Hospital 866 0
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Address: 866 0
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Country: Australia 866 0
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Approval Date: 866 0
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Submitted Date: 866 0
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HREC: 866 0
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Ethics Committee name: Princess Alexandra Hospital 867 0
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Address: 867 0
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Country: Australia 867 0
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Approval Date: 867 0
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Submitted Date: 867 0
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HREC: 867 0
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Ethics Committee name: Auckland Hospital 868 0
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Address: 868 0
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Country: New Zealand 868 0
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Approval Date: 868 0
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Submitted Date: 868 0
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HREC: 868 0
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Ethics Committee name: Christchurch Hospital 869 0
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Address: 869 0
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Country: New Zealand 869 0
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Approval Date: 869 0
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Submitted Date: 869 0
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HREC: 869 0
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Ethics Committee name: Wellington Hospital 870 0
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Address: 870 0
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Country: New Zealand 870 0
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Approval Date: 870 0
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Submitted Date: 870 0
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HREC: 870 0
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Ethics Committee name: Hamilton Health Sciences 871 0
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Address: 871 0
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Country: Canada 871 0
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Approval Date: 871 0
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Submitted Date: 871 0
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HREC: 871 0
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Brief summary
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Trial website
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Trial related presentations / publications
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Public Notes
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Principal Investigator
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Contact person for public queries
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Name: Ms Lynne Murray
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Address: Intensive Care Research The Alfred Commercial Road Melbourne VIC 3004
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Country: Australia
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Tel: +61 90763822
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Fax: +61 3 90763822
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Email: L.Murray@alfred.org.au
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Contact person for scientific queries
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Name: Assoc/Prof Jamie Cooper
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Address: Intensive Care Research The Alfred Commercial Road Melbourne VIC 3004
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Country: Australia
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Tel: +61 3 92071806
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Fax: +61 3 92762343
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Email: J.cooper@alfred.org.au
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