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

The primary outcome is neurological function measured at 6 months post injury using the Glasgow Outcome Score. Neurological function is qualified as proportion of favourable outcomes (GOSE grades 5-8).

Condition	Intervention	Phase
Severe diffuse traumatic brain injury with refractory intracranial hypertension.	Procedure: Early decompressive craniectomy	Phase III

Further Study Details: 

Primary Outcomes: Glasgow Outcome Score (GOSE)measured 6 months after injury.; Proportion (%) of Favourable Outcomes (GOSE 5-8) primary outcome measure.
Secondary Outcomes: Mean and maximum hourly ICP.; Favourable outcomes (GOSE) at 12 months post injury.; Mean GOSE at 6 months and 12 months using ordinal logistic regression.; Mortality - hospital 6 months, 12 months; Days in ICU in hospital; Brain metabolites using microdialysis (The Alfred only).
Expected Total Enrollment:  210

Ages Eligible for Study:  15 Years   -   60 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Age 15-60, First 72 hours from time of injury

Severe diffuse traumatic brain injury defined as:

• GCS<9, and CT scan with evidence of brain swelling (DII plus some evidence of DIII or DIV).
• GCS>8, before intubation and DIII or DIV, and CT scan (basal cistern compression +/- midling shift).
• ICP monitor in situ. EVD recommended. Parenchymal ICP catheter (Codman) acceptable when technical difficulties or other factors mean that an EVD is not in place. Some patients will have an EVD occluded by brain swelling. These should then have a Codman type catheter inserted additionally to enable ICP measurements, and appropriate therapies. The decision whether or not to use an EV, and EVD insertion and drainage must be doen before randomisation.
• Refractory ICP despite best conventional management (according to the study protocol). Refractory ICP in this study will be defined as the spontaneous persistent increase in ICP despite optimal conventional ICU therapies (including intermittent EVD venting) of >20mmHg for more than 15 mins (continuously or cumulative over one hour). ICP elevations associated with coughing, suctioning, turning or other similar stimuli will not be included.

Please refer to this study by ClinicalTrials.gov identifier  NCT00155987

D. J. Cooper      +61 3 9276 1805    j.cooper@alfred.org.au

Australia, Victoria
      The Alfred Hospital, Melbourne,  Victoria,  3004,  Australia; Recruiting

Study chairs or principal investigators

D. J. Cooper,  Principal Investigator,  The Alfred Hospital & National Trauma Research Institute   

Study ID Numbers:  68/02
Last Updated:  September 9, 2005
Record first received:  September 7, 2005
ClinicalTrials.gov Identifier:  NCT00155987
Health Authority: Australia: Human Research Ethics Committee
ClinicalTrials.gov processed this record on 2005-09-13