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

NCT00155987 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 155

Last updated 2020-09-10

No results posted yet for this study

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

Interventions

PROCEDURE

Early decompressive craniectomy

Large bifrontotemporal decompressive craniectomy

Sponsors & Collaborators

  • National Health and Medical Research Council, Australia

    collaborator OTHER

  • Victorian Trauma Foundation

    collaborator OTHER

  • ANZICS Foundation

    collaborator OTHER

  • Western Australian Institute for Medical Research

    collaborator OTHER

  • National Trauma Research Institute

    lead OTHER

Principal Investigators

  • D. J. Cooper · The Alfred Hospital & National Trauma Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
15 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-08-31
Primary Completion
2010-11-30
Completion
2010-12-31

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00155987 on ClinicalTrials.gov