The DECRA trial

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12605000009617

Acronym

DECRA

Enrollment

155

Registered

2005-07-14

Start date

2003-08-25

Completion date

2010-04-16

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

In adults with severe diffuse traumatic brain injury and refractory intracranial hypertension, early bifrontotemporoparietal decompressive craniectomy decreased intracranial pressure and the length of stay in the ICU but was associated with more unfavorable outcomes.

Interventions

Early decompressive craniectomy

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

15 Years to 60 Years

Healthy volunteers

Inclusion criteria

First 72 hours from time of injury-Severe diffuse traumatic brain injury-ICP monitor in-situ -Refractory intracranial hypertension

Exclusion criteria

Mass lesion>3cm-EDH/SDH>0.5cm or requiring evacuation-Spinal cord injury-Penetrating brain injury-Cardiac arrest at scene-Fixed dilated pupils and GCS=3-Neurosurgery contraindicated-No chance of survival after review of CT brain scan and clinical findings (Neurosurgeon decision).

Outcome results