Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000444280
Ethics application status
Approved
Date submitted
22/05/2009
Date registered
12/06/2009
Date last updated
13/11/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
The Paracetamol After traumatic Brain Injury Study
Scientific title
A multi-centre phase 2b randomised controlled trial investigating the efficacy and safety of intravenous paracetamol in reducing core body temperature after traumatic brain injury
Secondary ID [1] 273424 0
Nil known
Universal Trial Number (UTN)
Trial acronym
The PARITY Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Traumatic brain injury 4843 0
Condition category
Condition code
Injuries and Accidents 237188 237188 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Dose: Intravenous paracetamol, 1 gram (100mls), administered over 30 minutes.

Schedule: Given every 4 hours for 3 days.
Intervention code [1] 236624 0
Treatment: Drugs
Comparator / control treatment
Dose: Identical placebo: 100mls saline given intravenous over 30 minutes.

Schedule: every 4 hours for 3 days
Control group
Placebo

Outcomes
Primary outcome [1] 238004 0
Bladder Temperature using temperature sensing indwelling catheters
Timepoint [1] 238004 0
Mean bladder temperature from the start of study treatment until 4 hours after completion of study treatment period (this is a 76 hour study period).
Secondary outcome [1] 242138 0
Blood Pressure (systolic and mean arterial pressure) measured by intra-arterial pressure monitor
Timepoint [1] 242138 0
6 hourly during study treatment
Secondary outcome [2] 242139 0
Liver function test
Timepoint [2] 242139 0
daily from first dose of study treatment to the 7th day
Secondary outcome [3] 242140 0
serum Paracetamol levels (blood analysis) after a single dose of study drug and after final dose of study drug.
Timepoint [3] 242140 0
baseline, 30, 45, 90, 240 minutes after single dose. 240 minutes after final dose of study drug
Secondary outcome [4] 242303 0
The use of Physical Cooling: defined as whether a physical cooling device (e.g. ice packs, cooling blanket or intravenous cooling catheter) was used - collected hourly (Yes/No)
Timepoint [4] 242303 0
Hourly from fisrt study drug treatment until 4 hours after final study drug treatment

Eligibility
Key inclusion criteria
Written informed consent has been obtained from the patient’s next of kin
Age > 18 and < 65
Non penetrating head injury requiring mechanical ventilation, and, with an abnormal CT head (defined by the presence of haemorrhage, contusion, swelling, compression of basal cisterns or herniation)
Within 72 hours of injury
Presence (or imminent placement) of arterial cannula
Alanine transferase level < 100
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Suspected paracetamol overdose
Clinician decision to institute any intervention that modifies body temperature
Body temperature at time of recruitment less that 36 degrees celsius or greater than 38.9 degrees celcius
Treatment with paracetamol, non-steroidal anti-inflammatory drugs or steroids in 3 days prior to admission
History of chronic liver disease or chronic alcohol abuse
Suspected malnutrition or weight < 60 kg
Renal failure with serum creatinine > 200
Haemodynamic instability defined as systolic blood pressure < 90 mmhg or requirement for noradrenaline or adrenaline exceeding 20mcg/minute
Minor head injury: either normal CT head or not expected to be in intensive care for 72 hours
Suspected pregnancy
GCS<3 with fixed dilated pupils
Moribund patient expected to die within 24 hours
Allergy to paracetamol

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)
Allocation concealment was maintained by having independent pharmacy/nursing staff prepare study treatment using a shroud to mask the study treatment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/09/2009
Actual
24/11/2010
Date of last participant enrolment
Anticipated
Actual
30/12/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
44
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 1726 0
2217
Recruitment postcode(s) [2] 1729 0
4029

Funding & Sponsors
Funding source category [1] 5002 0
Government body
Name [1] 5002 0
Australia and New Zealand College of Anaesthetists
Country [1] 5002 0
Australia
Funding source category [2] 290239 0
Charities/Societies/Foundations
Name [2] 290239 0
The Honda-St. George Critical Care Fellowship,
St. George and Sutherland Medical Research Foundation
Country [2] 290239 0
Australia
Primary sponsor type
Government body
Name
South Eastern Sydney and Illawarra Area Health Service
Address
Wollongong Hospital
Loftus Street
Wollongong NSW 2500
Country
Australia
Secondary sponsor category [1] 4523 0
None
Name [1] 4523 0
Address [1] 4523 0
Country [1] 4523 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 7104 0
Nepean Lead Human Research Ethics Committee
Ethics committee address [1] 7104 0
Ethics committee country [1] 7104 0
Australia
Date submitted for ethics approval [1] 7104 0
17/06/2009
Approval date [1] 7104 0
14/10/2009
Ethics approval number [1] 7104 0
Nepean Lead HREC

Summary
Brief summary
Although experimental and observational studies suggest that a raised body temperature after brain injury may be associated with adverse outcomes for patients, there is no evidence that intervening to reduce temperature improves patient outcomes. Current clinical practice involves the variable use of strategies that modify temperature despite the clinical uncertainty. The PARITY study is part of a programme of research developed at St George Hospital and the George Institute for International Health aiming to provide rigorous, high quality research to assess the effect of interventions that target normothermia after traumatic brain injury on patient-centred outcomes.
Trial website
n/a
Trial related presentations / publications
n/a
Public notes

Contacts
Principal investigator
Name 29638 0
Dr Dr Manoj Saxena
Address 29638 0
Department of Intensive Care Medicine, St. George Hospital,
Gray Street, Kogarah, NSW 2217
Country 29638 0
Australia
Phone 29638 0
+61291133373
Fax 29638 0
Email 29638 0
[email protected]
Contact person for public queries
Name 12885 0
Dr Dr Manoj K Saxena
Address 12885 0
Deprtment of Intensive Care Medicine,
St George hospital, Gray street, kogarah, NSW 2217
Country 12885 0
Australia
Phone 12885 0
+ 61 2 9113 3373
Fax 12885 0
+ 61 2 9113 3971
Email 12885 0
[email protected]
Contact person for scientific queries
Name 3813 0
Dr Dr Manoj K Saxena
Address 3813 0
Deprtment of Intensive Care Medicine,
St George hospital, Gray street, kogarah, NSW 2217
Country 3813 0
Australia
Phone 3813 0
+ 61 2 9113 3373
Fax 3813 0
+ 61 2 9113 3971
Email 3813 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
SourceTitleYear of PublicationDOI
EmbaseThe effect of paracetamol on core body temperature in acute traumatic brain injury: A randomised, controlled clinical trial.2015https://dx.doi.org/10.1371/journal.pone.0144740
N.B. These documents automatically identified may not have been verified by the study sponsor.