Status:
COMPLETED
The Paracetamol AfteR Traumatic Brain InjurY Study
Lead Sponsor:
Dr. M.K. Saxena
Collaborating Sponsors:
The George Institute
The University of New South Wales
Conditions:
Traumatic Brain Injury
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
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 paraceta...
Detailed Description
Traumatic head injury is a bruising of areas of the brain that occurs commonly as a result of a fall or a motor vehicle accident. Unfortunately, this is a common global occurrence and it occurs both i...
Eligibility Criteria
Inclusion
- 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
- 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
Exclusion
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2014
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT01231139
Start Date
October 1 2010
End Date
June 1 2014
Last Update
October 28 2014
Active Locations (2)
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1
St George Hospital
Sydney, New South Wales, Australia
2
Royal Brisbane and Women's Hospital
Brisbane, Queensland, Australia