The Paracetamol AfteR Traumatic Brain InjurY Study

NCT01231139 | Completed Phase 2 DMC

• 1 other identifier: PARITY
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 2

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.

Conditions

Traumatic Brain Injury

Keywords

Brain Injury; Temperature; Paracetamol; Phase 2; TBI

Outcome Measures

Primary Outcomes (1)

• Core body temperature: bladder temperature probe

  30 minutes after final dose of study drug has been administered

Secondary Outcomes (7)

• Blood Pressure (systolic and mean arterial pressure) measured by intra-arterial pressure monitor

  6 hourly during study treatment

• Liver function test

  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.

  baseline, 30, 45, 90, 240 minutes after single dose. 240 minutes after final dose of study drug

• Temperature (bladder and tympanic)

  Hourly from first study drug treatment until 4 hours after final study drug treatment

• The use of physical cooling interventions

  hourly during the period of study intervention

Study Arms (2)

Paracetamol

EXPERIMENTAL

Paracetamol dissolved in 0.9% Sodium Chloride

Drug: Paracetamol

0.9% Sodium Chloride

PLACEBO COMPARATOR

0.9% Sodium Chloride

Drug: 0.9% Sodium Chloride Schedule:

Interventions

Paracetamol DRUG

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

Also known as: Perfalgan

Paracetamol

0.9% Sodium Chloride Schedule: DRUG

Identical placebo: 100mls saline given intravenous over 30 minutes (every 4 hours for 3 days)

Also known as: Saline

0.9% Sodium Chloride

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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

Sponsors & Collaborators

• Dr. M.K. Saxena: lead
• The George Institute: collaborator
• The University of New South Wales: collaborator
• Royal Brisbane and Women's Hospital: collaborator

Study Sites (2)

St George Hospital

Sydney, New South Wales, Australia

Location

Royal Brisbane and Women's Hospital

Brisbane, Queensland, Australia

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic; Brain Injuries

Interventions

Acetaminophen; Sodium Chloride

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Manoj Saxena

  South East Sydney Illawarra Area Health Service

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Intensive Care Physician

Study Record Dates

• First Submitted: October 29, 2010
• First Posted: November 1, 2010
• Study Start: October 1, 2010
• Primary Completion: December 1, 2013
• Study Completion: June 1, 2014
• Last Updated: October 28, 2014

Record last verified: 2014-10

Locations

AU (2)