The Paracetamol AfteR Traumatic Brain InjurY Study
Condition: Traumatic Brain Injury
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Wounds and Injuries
Study type: Interventional
Phase: Phase 2

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.
    

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 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.
    

Intervention name(s): Paracetamol; 0.9% Sodium Chloride Schedule:
Intervention type(s): Drug; Drug
Intervention description(s): Intravenous paracetamol, 1 gram (100mls), administered over 30 minutes (every 4 hours for 3 days).; Identical placebo: 100mls saline given intravenous over 30 minutes (every 4 hours for 3 days)
Other intervention name(s): Perfalgan; Saline
Intervention MeSH terms: Acetaminophen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Brain Injury; Temperature; Paracetamol; Phase 2; TBI