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Search / Trial NCT00155987

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

Launched by NATIONAL TRAUMA RESEARCH INSTITUTE · Sep 7, 2005

Trial Information

Current as of April 25, 2025

Completed

Keywords

Severe Diffuse Tbi Refractory Intracranial Hypertension.

ClinConnect Summary

Comparison After meeting the entry criteria, and the patient will be randomised to either early DC surgery (see below) or best current conventional management. Those randomised to surgery will have the operation done within 6 hours of randomisation. They will then return to the ICU and be managed thereafter in the same way as the conventional arm. Patients in the conventional arm will have all the usual therapies for increasing ICP optimised again. They then may have cooling to 35.0C or thiopentone bolus or thiopentone coma. These options are at the clinicians discretion. Late DC surgery in...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 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).
  • Exclusion criteria:
  • 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).

Trial Officials

D. J. Cooper

Principal Investigator

The Alfred Hospital & National Trauma Research Institute

About National Trauma Research Institute

The National Trauma Research Institute (NTRI) is a leading organization dedicated to advancing the understanding and treatment of trauma-related injuries through rigorous scientific research and clinical trials. With a focus on improving patient outcomes, NTRI collaborates with healthcare institutions, researchers, and clinicians to develop innovative therapeutic strategies and evidence-based practices. By fostering a multidisciplinary approach, the institute aims to bridge the gap between laboratory discoveries and clinical applications, ultimately enhancing the quality of care for trauma patients. NTRI is committed to promoting safety and efficacy in trauma care through its comprehensive research initiatives and commitment to ethical standards in clinical research.

Locations

Melbourne, Victoria, Australia

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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