The DECRA Trial: Early Decompressive Craniectomy in Patients With Severe Traumatic Brain Injury

NCT00155987 | Completed Phase 3 DMC

• 1 other identifier: 68/02
• Study Type: interventional
• Target: 155
• Locations: 1 country
• Sites: 1

Brief Summary

This is a 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 (Glasgow Outcome Score Extended \[GOSE\] grades 5-8).

Conditions

Brain Injuries

Keywords

Severe diffuse TBI refractory intracranial hypertension.

Outcome Measures

Primary Outcomes (1)

• Proportion (%) of favourable outcomes (GOSE 5-8)

  6 month post injury

Secondary Outcomes (6)

• Mean and maximum hourly intracranial pressure (ICP)

  36hrs post randomisation

• Favourable outcomes (GOSE)

  12 months post injury

• Mean GOSE using ordinal logistic regression

  6 months and 12 months

• Mortality

  hospital, 6 months, 12 months

• length of stay

  ICU admisssion

Interventions

Early decompressive craniectomy PROCEDURE

Large bifrontotemporal decompressive craniectomy

Eligibility Criteria

• Age: 15 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age 15 - 60 years and within the first 72 hrs from time of injury
• Severe diffuse Traumatic Brain Injury defined as:
• GCS \< 9 and CT scan\* with any evidence of brain swelling CT brain scan (DII + some evidence of swelling or DIII or DIV) OR
• GCS \>8 before intubation and DIII or DIV CT brain scan (basal cistern compression ± midline shift)
• ICP monitor in situ. EVD recommended.
• "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 EVD venting) of \>20mm Hg for more than 15 mins (continuously or cumulative over one hour).

You may not qualify if:

• Intracranial haemorrhage \> 3 cm diameter
• Intracranial mixed haemorrhagic contusion \>5cm in long axis
• Previous craniectomy
• EDH/SDH/ or large contusion requiring evacuation
• EDH/SDH \>0.5 cm thickness
• Spinal cord injury
• Penetrating brain injury
• Arrest at scene
• Unreactive pupils \>4mm, and GCS=3
• Neurosurgery contraindicated (eg: severe coagulopathy)
• No chance of survival after consideration of CT and clinical findings following Neurosurgical consultant assessment (eg hemispheric infarct after carotid dissection).

Sponsors & Collaborators

• National Trauma Research Institute: lead
• National Health and Medical Research Council, Australia: collaborator
• Victorian Trauma Foundation: collaborator
• ANZICS Foundation: collaborator
• Western Australian Institute for Medical Research: collaborator

Study Sites (1)

The Alfred Hospital

Melbourne, Victoria, 3004, Australia

Location

MeSH Terms

Conditions

Brain Injuries

Condition Hierarchy (Ancestors)

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

Study Officials

• D. J. Cooper

  The Alfred Hospital & National Trauma Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Investigator

Study Record Dates

• First Submitted: September 7, 2005
• First Posted: September 12, 2005
• Study Start: August 1, 2003
• Primary Completion: November 1, 2010
• Study Completion: December 1, 2010
• Last Updated: September 10, 2020

Record last verified: 2020-09

Locations

AU (1)