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Trial registered on ANZCTR
Registration number
ACTRN12613000784718
Ethics application status
Approved
Date submitted
12/07/2013
Date registered
15/07/2013
Date last updated
22/01/2015
Type of registration
Prospectively registered
Titles & IDs
Public title
Relationship between peak temperature and survival of neutropenic sepsis in intensive care
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Scientific title
In patients in intensive care units with neutropenic sepsis, is there an association between peak temperature within the first 24 hours and in-hospital mortality?
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Secondary ID [1]
282773
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None
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Neutropenic sepsis
289524
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Febrile neutropenia
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Haematological malignancy
289590
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Condition category
Condition code
Infection
289849
289849
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0
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Other infectious diseases
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Cancer
289850
289850
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0
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Any cancer
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Blood
289851
289851
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0
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Other blood disorders
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Intervention/exposure
Study type
Observational
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Patient registry
True
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Target follow-up duration
3
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Target follow-up type
Months
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Description of intervention(s) / exposure
This is an observational study. The condition observed is peak temperature, as recorded in the ANZICS-APD database, within the first 24 hours in the intensive care unit.
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Intervention code [1]
287441
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Not applicable
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Comparator / control treatment
A contemporaneous cohort of patients with non-neutropenic sepsis.
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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In-hospital mortality, adjusted for illness severity by APACHE III risk of death (excluding temperature), and classified according to peak documented temperature during the first 24 hours following admission to the intensive care unit.
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Assessment method [1]
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Timepoint [1]
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During inpatient episode. No censoring is applied. Patients for whom inpatient survival data are not available at the time of analysis will be excluded.
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Secondary outcome [1]
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ICU length of stay, adjusted for illness severity by APACHE III risk of death (excluding temperature)
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Assessment method [1]
303560
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Timepoint [1]
303560
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During inpatient episode. No censoring is applied. Patients for whom inpatient survival data are not available at the time of analysis will be excluded.
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Eligibility
Key inclusion criteria
All patients admitted to an adult ICU at one of 157 centres in Australia and New Zealand between 2005 and 2013 for whom information is available on the Australian and New Zealand Intensive Care Society (ANZICS) Adult Patient Database (APD).
"Neutropenic sepsis" cohort:
White cell count equal to or less than 1.0 x10^9/L within the first 24 hours on the intensive care unit
APACHE-II diagnostic code indicating infection or haematological malignancy
"Neutropenic sepsis with haematological malignancy" cohort:
White cell count equal to or less than 1.0 x10^9/L within the first 24 hours on the intensive care unit
APACHE-II diagnostic or comorbidity code indicating haematological malignancy
"Non-neutropenic sepsis" cohort:
White cell count greater than or equal to 4.0 x10^9/L during the first 24 hours on the intensive care unit
APACHE-II diagnostic code indicating infection
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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
No recorded white cell count during first 24 hours on intensive care unit
No recorded temperature during first 24 hours on intensive care unit
For "Non-neutropenic sepsis" cohort only:
APACHE-II diagnostic code or comorbidity code indicating a haematological malignancy
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Study design
Purpose
Natural history
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Duration
Cross-sectional
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Selection
Defined population
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Timing
Retrospective
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Statistical methods / analysis
We will consider temperature as a categorical variable, divided into the following groups, according to peak temperature during the first 24 hours:
< 36.5 degrees Celsius (‘low temperature’)
36.5 degrees Celsius to 37.5 degrees Celsius (normothermia)
37.6 to 39.4 degrees Celsius (‘fever’)
>= 39.5 degrees Celsius (‘high fever’)
We will calculate odds ratios (95% CI) for the risk of in-hospital mortality associated with peak temperature for all patients. We will perform multivariate analysis using logistic regression adjusting for the patient’s severity of illness (by APACHE III score excluding temperature). To establish if the relationship between temperature and hospital mortality differs between we will fit an interaction between temperature and the individual subgroups.
We shall undertake a sensitivity analysis for ‘admitted to ICU on day of hospital admission’ versus ‘admitted to ICU after the day of hospital admission’.
Continuous variables will be presented as mean +/- standard deviation (SD) and median +/- interquartile range [IQR] for parametric and non-parametric data, respectively. We will report categorical variables as counts and percentages. A two-sided p-value of 0.05 will be considered to be statistically significant.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
10/08/2013
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Actual
29/07/2013
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Date of last participant enrolment
Anticipated
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Actual
29/08/2014
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
10000
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
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Recruitment outside Australia
Country [1]
5166
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New Zealand
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State/province [1]
5166
0
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Funding & Sponsors
Funding source category [1]
287541
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Self funded/Unfunded
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Name [1]
287541
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Not relevant - unfunded
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Address [1]
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Not relevant - unfunded
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Country [1]
287541
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Primary sponsor type
Individual
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Name
Dr Robert Weinkove
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Address
Wellington Blood & Cancer Centre
Capital & Coast District Health Board
Private Bag 7902
Wellington 6242
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Country
New Zealand
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Secondary sponsor category [1]
286294
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None
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Name [1]
286294
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Address [1]
286294
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Country [1]
286294
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Other collaborator category [1]
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Individual
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Name [1]
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Dr Paul Young
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Address [1]
277512
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Intensive Care Unit
Wellington Hospital
Private Bag 7902
Wellington 6242
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Country [1]
277512
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New Zealand
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Other collaborator category [2]
277513
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Individual
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Name [2]
277513
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A/Prof David Pilcher
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Address [2]
277513
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ICU The Alfred
Commerical Road
PRAHRAN VIC 3161
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Country [2]
277513
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Australia
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Other collaborator category [3]
277514
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Individual
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Name [3]
277514
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Dr Constantine Tam
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Address [3]
277514
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Peter MacCallum Cancer Centre
Locked Bag 1
A'Beckett Street
VIC 8006
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Country [3]
277514
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Australia
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Other collaborator category [4]
277515
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Individual
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Name [4]
277515
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Professor Richard Beasley
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Address [4]
277515
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Medical Research Institute of New Zealand
Private Bag 7902
Wellington 6242
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Country [4]
277515
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New Zealand
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Other collaborator category [5]
277516
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Individual
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Name [5]
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Manoj Saxena
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Address [5]
277516
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The George Institute for Global Health
Level 13, 321 Kent St
Sydney NSW 2000
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Country [5]
277516
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Australia
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Other collaborator category [6]
277517
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Individual
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Name [6]
277517
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Assoc Prof Michael Bailey
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Address [6]
277517
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Epidemiology & Preventative Medicine
Monash Medical School Building
The Alfred Hospital
PO Box 315
Prahran VIC 3181
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Country [6]
277517
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Australia
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Other collaborator category [7]
277518
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Individual
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Name [7]
277518
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Professor Rinaldo Bellomo
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Address [7]
277518
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Epidemiology & Preventative Medicine
Monash Medical School Building
The Alfred Hospital
PO Box 315
Prahran VIC 3181
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Country [7]
277518
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
289522
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Alfred Hospital Ethics Committee
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Ethics committee address [1]
289522
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The Alfred Hospital,
55 Commercial Road,
Melbourne,
Victoria 3004
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Ethics committee country [1]
289522
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Australia
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Date submitted for ethics approval [1]
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19/07/2013
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Approval date [1]
289522
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22/07/2013
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Ethics approval number [1]
289522
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333/13
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Summary
Brief summary
In patients in intensive care with severe infections, those who do not develop a fever during the first 24 hours are more likely to die. This study aims to find out whether this is also the case in patients with infections in the absence of functioning white blood cells ('neutropenic sepsis'). We will look at a database of patients who were in intensive care in Australia and New Zealand between 2000 and 2013, to see whether there is a link between peak fever during the first 24 hours and survival among patients with very low white blood cell counts, compared with those with normal white blood cell counts. This study will inform the development of future clinical trials to decide whether the common medical practice of reducing fever during severe infections is harmful or not.
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Trial website
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Trial related presentations / publications
Association between early peak temperature and mortality in neutropenic sepsis. Weinkove R, Bailey M, Bellomo R, Saxena MK, Tam CS, Pilcher DV, Beasley R, Young PJ. Ann Hematol. 2014 Dec 18. [Epub ahead of print] PMID: 25516454
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Public notes
The Quality Assurance Legislation of the Commonwealth of Australia (Part VC Health Insurance Act 1973, Commonwealth of Australia) allows use of data for research purposes without individual patient consent or specific ethical approval.
In New Zealand, this use of anonymous use of data for outcome analysis is classified as a ‘minimal risk’ observational study, and is exempt from requirements for formal ethics approval.
The ANZICS Centre for Outcome and Resource Evaluation (CORE) Management Committee have reviewed this protocol.
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Contacts
Principal investigator
Name
41174
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Dr Robert Weinkove
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Address
41174
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Wellington Blood & Cancer Centre
Capital & Coast District Health Board
Private Bag 7902
Wellington 6242
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Country
41174
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New Zealand
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Phone
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+64221746400
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Fax
41174
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Email
41174
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[email protected]
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Contact person for public queries
Name
41175
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Dr Robert Weinkove
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Address
41175
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Wellington Blood & Cancer Centre
Capital & Coast District Health Board
Private Bag 7902
Wellington 6242
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Country
41175
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New Zealand
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Phone
41175
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+6443855999
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Fax
41175
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Email
41175
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[email protected]
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Contact person for scientific queries
Name
41176
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Dr Robert Weinkove
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Address
41176
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Wellington Blood & Cancer Centre
Capital & Coast District Health Board
Private Bag 7902
Wellington 6242
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Country
41176
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New Zealand
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Phone
41176
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+6443855999
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Fax
41176
0
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Email
41176
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[email protected]
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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.
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