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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
This primary aim is to investigate the effect of paracetamol in reducing body temperature in patients who have sustained traumatic brain injury. This study is also investigating the safety of paracetamol in this patient population.
Trial website
https://clinicaltrials.gov/study/NCT01231139
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01231139