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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00987688




Registration number
NCT00987688
Ethics application status
Date submitted
29/09/2009
Date registered
1/10/2009

Titles & IDs
Public title
The Prophylactic Hypothermia Trial to Lessen Traumatic Brain Injury
Scientific title
Multi-centre Randomised Trial to Evaluate the Effect of Early Hypothermia on Neurological Function in Patients With Severe Traumatic Brain Injury. Including Renal Sub Study
Secondary ID [1] 0 0
ANZIC-RC/DJC003
Universal Trial Number (UTN)
Trial acronym
POLAR-RCT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Brain Injuries, Traumatic 0 0
Condition category
Condition code
Injuries and Accidents 0 0 0 0
Other injuries and accidents
Neurological 0 0 0 0
Other neurological disorders
Skin 0 0 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Hypothermia

Experimental: Hypothermia - Early and sustained hypothermia.

No intervention: Normothermia - Standard management


Other interventions: Hypothermia
exposure: 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 72 hours. Rewarming will occur at a rate of 1C/4hrs and will be titrated to intracranial pressure (ICP) control and BP.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The proportion of favourable neurological outcomes (Glasgow Outcome Score Extended: GOSE 5 to 8)
Timepoint [1] 0 0
6 months post injury
Secondary outcome [1] 0 0
Probability of an equal or greater GOSE level at 6 months compared to the probability of a lesser GOSE level, using a proportional odds model or partial proportional odds model
Timepoint [1] 0 0
6 months post injury
Secondary outcome [2] 0 0
Quality of life assessments (QOL) o EQ5D o SF12
Timepoint [2] 0 0
6 months post injury
Secondary outcome [3] 0 0
Average causal effect of hypothermia on GOSE at 6 months comparing hypothermia and control patients who would survive regardless of treatment assignment.
Timepoint [3] 0 0
6 months post injury
Secondary outcome [4] 0 0
Mortality
Timepoint [4] 0 0
Hospital Discharge and 6 Months post injury
Secondary outcome [5] 0 0
Incidence of adverse events, specifically: o Bleeding o Infection.
Timepoint [5] 0 0
Up to study day 10
Secondary outcome [6] 0 0
Health economic evaluation
Timepoint [6] 0 0
6 Months post injury
Secondary outcome [7] 0 0
Pre-Specified sub group
Timepoint [7] 0 0
6 Months post injury
Secondary outcome [8] 0 0
Dose effect / Intensity of cooling
Timepoint [8] 0 0
6 months post injury

Eligibility
Key inclusion criteria
* Blunt trauma with clinical diagnosis of severe TBI and GCS <9
* Estimated age = 18 and < 60 years of age
* The patient is intubated or intubation is imminent
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Pre-hospital:

* 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
* GCS=3 + un-reactive pupils
* Penetrating neck/torso injury
* Known or obvious pregnancy
* Receiving hospital is not a study site
* Evidence of current anti-coagulant treatment
* Emergency Dept:

* 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
* GCS=3 + un-reactive pupils
* Persistent Systolic BP <90mmHg
* 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
* In the treating clinician's opinion, "cooling" is not in the patient's best interest

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
15/06/2018
Sample size
Target
Accrual to date
Final
511
Recruitment in Australia
Recruitment state(s)
QLD,VIC,WA
Recruitment hospital [1] 0 0
Princess Alexandra Hospital - Brisbane
Recruitment hospital [2] 0 0
Gold Coast University Hospital - Gold Coast
Recruitment hospital [3] 0 0
The Royal Melbourne Hospital - Melbourne
Recruitment hospital [4] 0 0
Alfred Hospital - Prahran
Recruitment hospital [5] 0 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 0 0
- Brisbane
Recruitment postcode(s) [2] 0 0
- Gold Coast
Recruitment postcode(s) [3] 0 0
- Melbourne
Recruitment postcode(s) [4] 0 0
3004 - Prahran
Recruitment postcode(s) [5] 0 0
- Perth
Recruitment outside Australia
Country [1] 0 0
France
State/province [1] 0 0
Franche Comte
Country [2] 0 0
France
State/province [2] 0 0
Brest
Country [3] 0 0
France
State/province [3] 0 0
Clermont-Ferrand
Country [4] 0 0
France
State/province [4] 0 0
Nimes
Country [5] 0 0
France
State/province [5] 0 0
Strasbourg
Country [6] 0 0
New Zealand
State/province [6] 0 0
North Island
Country [7] 0 0
Qatar
State/province [7] 0 0
Doha
Country [8] 0 0
Saudi Arabia
State/province [8] 0 0
Riyadh
Country [9] 0 0
Switzerland
State/province [9] 0 0
Bern

Funding & Sponsors
Primary sponsor type
Other
Name
Australian and New Zealand Intensive Care Research Centre
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Australian and New Zealand Intensive Care Society Clinical Trials Group
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
National Health and Medical Research Council, Australia
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Transport Accident Commision, Victoria
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
Monash University
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Other
Name [5] 0 0
Délégation à la Recherche Clinique et à l'Innovation (DRCI) CHU Besançon
Address [5] 0 0
Country [5] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jamie Cooper, BMBS, MD
Address 0 0
ANZIC RC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT00987688