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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01231139




Registration number
NCT01231139
Ethics application status
Date submitted
29/10/2010
Date registered
1/11/2010
Date last updated
28/10/2014

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] 0 0
PARITY
Universal Trial Number (UTN)
Trial acronym
PARITY
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Traumatic Brain Injury 0 0
Condition category
Condition code
Injuries and Accidents 0 0 0 0
Other injuries and accidents
Neurological 0 0 0 0
Other neurological disorders
Skin 0 0 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Paracetamol
Treatment: Drugs - 0.9% Sodium Chloride Schedule:

Experimental: Paracetamol - Paracetamol dissolved in 0.9% Sodium Chloride

Placebo comparator: 0.9% Sodium Chloride - 0.9% Sodium Chloride


Treatment: Drugs: Paracetamol
Intravenous paracetamol, 1 gram (100mls), administered over 30 minutes (every 4 hours for 3 days).

Treatment: Drugs: 0.9% Sodium Chloride Schedule:
Identical placebo: 100mls saline given intravenous over 30 minutes (every 4 hours for 3 days)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Core body temperature: bladder temperature probe
Timepoint [1] 0 0
30 minutes after final dose of study drug has been administered
Secondary outcome [1] 0 0
Blood Pressure (systolic and mean arterial pressure) measured by intra-arterial pressure monitor
Timepoint [1] 0 0
6 hourly during study treatment
Secondary outcome [2] 0 0
Liver function test
Timepoint [2] 0 0
daily from first dose of study treatment to the 7th day
Secondary outcome [3] 0 0
serum Paracetamol levels (blood analysis) after a single dose of study drug and after final dose of study drug.
Timepoint [3] 0 0
baseline, 30, 45, 90, 240 minutes after single dose. 240 minutes after final dose of study drug
Secondary outcome [4] 0 0
Temperature (bladder and tympanic)
Timepoint [4] 0 0
Hourly from first study drug treatment until 4 hours after final study drug treatment
Secondary outcome [5] 0 0
The use of physical cooling interventions
Timepoint [5] 0 0
hourly during the period of study intervention
Secondary outcome [6] 0 0
Intracranial pressure
Timepoint [6] 0 0
6 hourly during the period of study intervention
Secondary outcome [7] 0 0
Incidence of cerebral hypoperfusion
Timepoint [7] 0 0
During study intervention period

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 or allergy to paracetamol
* Confirmed or suspected pregnancy
* Use of pharmacological or physical intervention that reduces body temperature in the 6-hour period prior to randomisation.
* Clinician decision to institute any pharmacological or physical intervention that modifies body temperature
* Body temperature at time of recruitment less that 36°C or greater than 38.9°C
* History of chronic liver disease or chronic alcohol abuse
* Suspected malnutrition: BMI < 18 kg/m2 or weight < 60 kg
* BMI > 35 kg/m2
* Renal failure with serum creatinine > 200
* Haemodynamic instability defined as systolic blood pressure < 90 mmhg or requirement for noradrenaline or adrenaline exceeding 20mcg/minute
* Use of hepatic enzyme inducers, except for phenytoin
* Minor head injury: either normal CT head or not expected to be in intensive care for 72 hours
* GCS = 3 with fixed dilated pupils
* Moribund patient expected to die within 24 hours

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2014
Sample size
Target
Accrual to date
Final
41
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 0 0
St George Hospital - Sydney
Recruitment hospital [2] 0 0
Royal Brisbane and Women's Hospital - Brisbane
Recruitment postcode(s) [1] 0 0
- Sydney
Recruitment postcode(s) [2] 0 0
- Brisbane

Funding & Sponsors
Primary sponsor type
Other
Name
Dr. M.K. Saxena
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
The George Institute
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
The University of New South Wales
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Government body
Name [3] 0 0
Royal Brisbane and Women's Hospital
Address [3] 0 0
Country [3] 0 0

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Manoj Saxena
Address 0 0
South East Sydney Illawarra Area Health Service
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

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

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT01231139