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Clinical Trials/ISRCTN61037228
ISRCTN61037228
Completed
Not Applicable

Multi-centre prospective randomised trial of early decompressive craniectomy in patients with severe traumatic brain injury

ational Trauma Research Institute, The Alfred Hospital (Australia)0 sites165 target enrollmentJuly 21, 2005
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ConditionsSevere traumatic brain injuryInjury, Occupational Diseases, Poisoning

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Severe traumatic brain injury
Sponsor
ational Trauma Research Institute, The Alfred Hospital (Australia)
Enrollment
165
Status
Completed
Last Updated
9 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
July 21, 2005
End Date
TBD
Last Updated
9 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
ational Trauma Research Institute, The Alfred Hospital (Australia)

Eligibility Criteria

Inclusion Criteria

  • •1\. Age 15\-60 years
  • •2\. First 72 hours from time of injury
  • •3\. Severe diffuse Traumatic Brain Injury defined as:
  • •3\.1\. Glasgow Coma Score (GCS) \<9 and computed tomography (CT) scan with any evidence of brain swelling. CT brain scan DII \+ some evidence of swelling or DIII or DIV
  • •3\.2\. GCS \>8 before intubation and DIII or DIV. CT brain scan basal cistern compression ± midline shift
  • •4\. Intracanial pressure (ICP) monitor in situ
  • •5\. 'Refractory ICP' despite best conventional management. Refractory ICP in this study will be defined as the spontaneous persistent increase in ICP despite optimal conventional ICU therapies (including intermittent external ventricular drain \[EVD] venting) of \>20 mm Hg for more than 15 mins (continuously or cumulative over one hour).

Exclusion Criteria

  • •1\. Intracranial mass lesion (\>3 cm diameter) and/or previous craniectomy
  • •2\. Extradural hematoma / subdural hematoma (EDH/SDH) requiring evacuation
  • •3\. EDH/SDH \>0\.5 cm thickness
  • •4\. Spinal cord injury
  • •5\. Penetrating brain injury
  • •6\. Arrest at scene
  • •7\. Unreactive pupils \>4 mm and GCS \= 3
  • •8\. Neurosurgery contraindicated
  • •9\. No chance of survival after consideration of CT and clinical findings, following Neurosurgical consultant assessment

Outcomes

Primary Outcomes

Not specified

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