The Paracetamol AfteR Traumatic Brain InjurY Study (PARITY)
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|ClinicalTrials.gov Identifier: NCT01231139|
Recruitment Status : Completed
First Posted : November 1, 2010
Last Update Posted : October 28, 2014
|Condition or disease||Intervention/treatment||Phase|
|Traumatic Brain Injury||Drug: Paracetamol Drug: 0.9% Sodium Chloride Schedule:||Phase 2|
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 in developing and developed countries. It causes death in nearly 1 in 3 of those who are most severely affected and a large proportion of those that survive have long-term physical or mental disability. Hence, traumatic head injury is a major global problem.
At present there are very few therapies that are known to be effective after a traumatic head injury. In particular the investigators are uncertain about whether modifying body temperature has any effect (good or bad) on the outcomes of patients. Although, this is practiced by some intensive care units around the world.
The investigators have searched extensively to look for any evidence that altering body temperature after traumatic head injury improves the outcome of patients (by reducing the amount of death or disability) and were unable to find any evidence at all. Some preliminary research in both animal experiments and clinical studies suggest that a raised temperature after forms of brain injury may in fact be harmful.
Therefore, at present the investigators believe that we do not really know what effect changing body temperature after head injury has on the outcome of patients.
The investigators are proposing to conduct a clinical study of patients who have had a severe head injury. The patients will be randomly allocated to 2 groups who will get either regular Paracetamol (dissolved in fluid) or a bottle of fluid without any Paracetamol. The 2 treatments will look identical and neither the patients nor the health care workers will know what treatment they are getting. Doing the study in this way will allow us to work out whether giving Paracetamol reduces the temperature of the body and whether there are any side effects that occur. If the study shows that Paracetamol can reduce body temperature safely in this setting then the investigators will work towards doing a larger study of treatments that reduce body temperature. The purpose of this larger study would be to see if the investigators can, not only reduce body temperature but also reduce amount of disability (physical and mental) as well as the death rate in traumatically brain injured patients.
In the proposed study the investigators will be using a higher dose of Paracetamol that is usually prescribed. Other research has shown that the dose that the investigators are proposing to use is safe and also that smaller doses in fact do not reduce body temperature.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||41 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official 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|
|Study Start Date :||October 2010|
|Actual Primary Completion Date :||December 2013|
|Actual Study Completion Date :||June 2014|
Paracetamol dissolved in 0.9% Sodium Chloride
Intravenous paracetamol, 1 gram (100mls), administered over 30 minutes (every 4 hours for 3 days).
Other Name: Perfalgan
Placebo Comparator: 0.9% Sodium Chloride
0.9% Sodium Chloride
Drug: 0.9% Sodium Chloride Schedule:
Identical placebo: 100mls saline given intravenous over 30 minutes (every 4 hours for 3 days)
Other Name: Saline
- Core body temperature: bladder temperature probe [ Time Frame: 30 minutes after final dose of study drug has been administered ]
- Blood Pressure (systolic and mean arterial pressure) measured by intra-arterial pressure monitor [ Time Frame: 6 hourly during study treatment ]
- Liver function test [ Time Frame: daily from first dose of study treatment to the 7th day ]
- serum Paracetamol levels (blood analysis) after a single dose of study drug and after final dose of study drug. [ Time Frame: baseline, 30, 45, 90, 240 minutes after single dose. 240 minutes after final dose of study drug ]
- Temperature (bladder and tympanic) [ Time Frame: Hourly from first study drug treatment until 4 hours after final study drug treatment ]Time-weighted mean, area under the 3-day temperature curve, daily maximum and minimum temperature
- The use of physical cooling interventions [ Time Frame: hourly during the period of study intervention ]
- Intracranial pressure [ Time Frame: 6 hourly during the period of study intervention ]Mean daily intracranial pressure for day 1, 2 and 3.
- Incidence of cerebral hypoperfusion [ Time Frame: During study intervention period ]
- Systolic blood pressure < 90 mmhg or Mean arterial pressure < 50 mmhg for > 15 minutes
- Cerebral perfusion pressure < 50 mmhg for > 15 minutes
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01231139
|Australia, New South Wales|
|St George Hospital|
|Sydney, New South Wales, Australia|
|Royal Brisbane and Women's Hospital|
|Brisbane, Queensland, Australia|
|Principal Investigator:||Manoj Saxena||South East Sydney Illawarra Area Health Service|