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ACTRN12609000764235
Alternative entry with additional local information: NCT00987688

The prophylactic hypothermia trial to lessen traumatic brain injury – randomised controlled trial.

Data source: WHO (Imported from 20.03.2024)
Changed: Oct 6, 2019, 2:00 AM
Disease category:

Health conditions (Data source: WHO)

Severe traumatic brain injury;
Severe traumatic brain injury;Neurological - Other neurological disorders;Injuries and Accidents - Other injuries and accidents

Interventions (Data source: WHO)

Early and sustained hypothermia. Hypothermia will initially be induced by infusion of up to 2L ice cold saline. Following a safety assessment the patient will be rapidly cooled to 33C using surface temperature control equipment. They will be maintained at 33C for 72hours. Slow rewarming will occur at a rate of 1C/4hrs and will be titrated to intracranial pressure (ICP) control and blood pressure.

Inclusion/Exclusion Criteria (Data source: WHO)

Inclusion criteria: Pre-hospital Inclusion Criteria
*Blunt trauma with clinical diagnosis of severe Traumatic Brain Injury (TBI) and Glasgow Coma Scale <9
*Estimated age = 18 and < 60 years of age
*The patient is intubated or intubation is imminent
Emergency Dept Inclusion Criteria
*Blunt trauma with clinical diagnosis of severe TBI and GCS <9
*Estimated age > or = 18 and < 60 years of age
*The patient is intubated or intubation is imminent
Exclusion criteria: ***********Pre-hospital Exclusion Criteria
Clinical diagnosis of drug or alcohol intoxication as predominant cause of coma
Randomisation unable to be performed within 3 hrs of estimated time of injury
Estimated transport time to study hospital >2.5hrs
Able to be intubated without drugs
Systolic BP <90mmHg
Heart rate > 120bpm
Cardiac arrest at the scene or in transit
GCS=3 and un-reactive pupils
Penetrating neck/torso injury
Known or obvious pregnancy
Receiving hospital is not a study site
Evidence of current anti-coagulant treatment
Known to be carer dependent due to a pre-existing neurological condition

***********Emergency Dept Exclusion Criteria
Clinical diagnosis of drug or alcohol intoxication as predominant cause of coma
Randomisation unable to be performed within 3 hrs of estimated time of injury
Able to be intubated without drugs
Persistent Systolic BP <90mmHg
GCS=3 + un-reactive pupils
Cardiac arrest at the scene or in transit
Clinically significant bleeding likely to require haemostatic intervention, for example:
Bleeding into the chest, abdomen or retro-peritoneum likely to require surgery +/- embolisation
**Pelvic fracture likely to require surgery +/- embolisation
**More than two long bone fractures requiring operative fixation
**Penetrating neck/torso injury
Positive urine or blood pregnancy test
Evidence of current anti-coagulant treatment
Known to be carer dependent due to a pre-existing neurological condition
In the treating clinician’s opinion, cooling” is not in the patient’s best interest


Further information on the trial in WHO primary registry

https://anzctr.org.au/ACTRN12609000764235.aspx

Further information on the trial from WHO database (ICTRP)

https://trialsearch.who.int/Trial2.aspx?TrialID=ACTRN12609000764235
Further information on trial

Date trial registered

Sep 3, 2009

Incorporation of the first participant

Apr 20, 2010

Recruitment status

Recruiting

Academic title (Data source: WHO)

Multi-centre randomised trial to evaluate the effect of early hypothermia on neurological function in patients with severe traumatic brain injury.

Type of trial (Data source: WHO)

Interventional

Design of the trial (Data source: WHO)

Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Open (masking not used);Assignment: Parallel;Type of endpoint: Efficacy

Phase (Data source: WHO)

Not Applicable

Primary end point (Data source: WHO)

The proportion of favourable neurological outcomes (Glasgow Outcome Score Extended: GOSE 5 to 8)[6 months post injury]

Secundary end point (Data source: WHO)

Levels of biomarkers neutrophil gelatinase-associated lipocalin (NGAL), cystatin C and liver-type fatty acid binding protein (L-FABP) will be measured in plasma and urine from blood and urine specimens obtained from 50 patients. Levels of these biomarkers will be compared in those receiving cooling v. normothermia. Urine NGAL will be measured using the Abbott point-of-care test and other measurements will be performed in accredited laboratories using standardised methods for each biomarker.[24hrs, 48 hrs, 72 hrs post Intensive Care admission];Cumulative proportion of patients with Acute Kidney Injury (Injury/Failure Risk Injury Failure Loss End stage (RIFLE) categories) in those receiving cooling v. normothermia[Day 7 of hospital admission.];Incidence of adverse events
*Significant bleeding - assessed clinically
*Infection - assessed clinically[Assessed as part of normal intensive care management during the study intervention];Proportion of favourable (GOSE 5-8) neurological outcomes in survivors[6 months post injury];Mortality[6 months post injury, hospital discharge & Intensive Care Unit (ICU)discharge];Quality of life assessments
*SF-12 (version 1)
*EQ5D[6 months post injury]

Contact information (Data source: WHO)

NHMRC;Victorian Neurotrauma Initiative

Trial results (Data source: WHO)

Results summary

no information available yet

Link to the results in the primary register

no information available yet

Information on the availability of individual participant data

no information available yet

Trial sites

Countries (Data source: WHO)

Australia, France, New Zealand, Qatar, Switzerland
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