Brain InjuriesPhase 3NCT00155987
The DECRA Trial: Early Decompressive Craniectomy in Patients With Severe Traumatic Brain Injury
A Phase 3 study testing Early decompressive craniectomy in people with Brain Injuries, run by National Trauma Research Institute at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 60 years
- Conditions the study is for
- Brain Injuries
- What is being tested?
- Early decompressive craniectomy
- Type of treatment
- Surgery or procedure
- How many people
- 155 participants
- Where
- 1 siteAustralia
- Study dates
- Aug 2003to Dec 2010
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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).
Who cannot join
- 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
Show all 11Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Multi-centre Prospective Randomised Trial of Early Decompressive Craniectomy in Patients With Severe Traumatic Brain Injury
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).
Read the detailed description
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 the control patients is discouraged however it may be done at the neurosurgeons discretion. These patients will be included in the intention to treat analysis.
Surgical Technique The technique described by Polin will be used. The operation will comprise bi-frontal decompressive craniectomies with a single fronto-temporal bone flap extending across the midline. The temporalis muscles will be reflected inferiorly. Burr holes are located either side of the sagittal sinus at the posterior extent and bilaterally at the keyhole and at the root of the zygoma. This will create a large bifrontal craniectomy defect extending posteriorly to the coronal sutures. Bilateral large sub-temporal decompressions will be performed down to the skull base. The final bone cut is made along the supra-orbital ridges with an attempt to preserve the frontal sinus. Burr holes will be placed either side of the sagittal sinus inferiorly and the bone will be lifted out.
The dura will be opened in one of two alternative ways:
- The dura is opened with a cruciate incision bilaterally. OR
- A large L shaped incision with the lower corner of the L facing laterally. The advantage to this method is that the cerebral veins are not disturbed medially by this incision.
The dural opening should be covered with a dural or facial patch, so that the brain does not adhere to the scalp. Water tight dural closure is not necessarily aimed for. For patients receiving EVD monitoring, an ICP monitor with ventricular catheter (± optional PO2 and temperature monitor) may be placed prior to closure. Some patients will have been randomised to parenchymal catheter only. These patients will not have an EVD inserted.
The bone flap is replaced once bone swelling has resolved and the patient has improved and left the intensive care unit (6-12 weeks). The bone flap is stored at minus 20o-70oC until reinsertion or it may be implanted in the subcutaneous tissue of the abdominal wall as an alternative.
- Conditions
- Brain Injuries
- Being tested
- Early decompressive craniectomy
- Keywords
- Severe diffuse TBI refractory intracranial hypertension.
- Medical subject headings
- Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early decompressive craniectomyProcedure or surgery
Large bifrontotemporal decompressive craniectomy
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion (%) of favourable outcomes (GOSE 5-8)
Measured: 6 month post injury
Secondary outcomes (6)
Mean and maximum hourly intracranial pressure (ICP)
Measured: 36hrs post randomisation
Favourable outcomes (GOSE)
Measured: 12 months post injury
Mean GOSE using ordinal logistic regression
Measured: 6 months and 12 months
Mortality
Measured: hospital, 6 months, 12 months
length of stay
Measured: ICU admisssion
Brain metabolites using microdialysis (The Alfred Hospital only)
Measured: During monitoring phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startAug 2003
- Primary completionNov 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 155 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Trauma Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Health and Medical Research Council, Australia, Victorian Trauma Foundation, ANZICS Foundation, Western Australian Institute for Medical Research
- Responsible party
- Principal investigator, Prof Jamie Cooper, National Trauma Research Institute
- Investigators
- D. J. Cooper, Principal investigator, The Alfred Hospital & National Trauma Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00155987
- Sponsor's protocol ID
- 68/02
- Status last verified
- Sep 2020
- First submitted
- 7 Sep 2005
- Last updated
- 10 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-centre Prospective Randomised Trial of Early Decompressive Craniectomy in Patients With Severe Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT00155987
- Acronym / sponsor ID
- 68/02
- Conditions
- Brain Injuries
- Keywords
- Severe diffuse TBI refractory intracranial hypertension.
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 155 participants (actual)
- Lead sponsor
- National Trauma Research InstituteUniversity, hospital or other
- Collaborators
- National Health and Medical Research Council, Australia, Victorian Trauma Foundation, ANZICS Foundation, Western Australian Institute for Medical Research
- Study start
- Aug 2003
- Primary completion
- Nov 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 12 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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 the control patients is discouraged however it may be done at the neurosurgeons discretion. These patients will be included in the intention to treat analysis.
Surgical Technique The technique described by Polin will be used. The operation will comprise bi-frontal decompressive craniectomies with a single fronto-temporal bone flap extending across the midline. The temporalis muscles will be reflected inferiorly. Burr holes are located either side of the sagittal sinus at the posterior extent and bilaterally at the keyhole and at the root of the zygoma. This will create a large bifrontal craniectomy defect extending posteriorly to the coronal sutures. Bilateral large sub-temporal decompressions will be performed down to the skull base. The final bone cut is made along the supra-orbital ridges with an attempt to preserve the frontal sinus. Burr holes will be placed either side of the sagittal sinus inferiorly and the bone will be lifted out.
The dura will be opened in one of two alternative ways:
- The dura is opened with a cruciate incision bilaterally. OR
- A large L shaped incision with the lower corner of the L facing laterally. The advantage to this method is that the cerebral veins are not disturbed medially by this incision.
The dural opening should be covered with a dural or facial patch, so that the brain does not adhere to the scalp. Water tight dural closure is not necessarily aimed for. For patients receiving EVD monitoring, an ICP monitor with ventricular catheter (± optional PO2 and temperature monitor) may be placed prior to closure. Some patients will have been randomised to parenchymal catheter only. These patients will not have an EVD inserted.
The bone flap is replaced once bone swelling has resolved and the patient has improved and left the intensive care unit (6-12 weeks). The bone flap is stored at minus 20o-70oC until reinsertion or it may be implanted in the subcutaneous tissue of the abdominal wall as an alternative.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
Who may qualify
- Ages
- 15 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early decompressive craniectomyLarge bifrontotemporal decompressive craniectomy | Procedure or surgery | – |
Primary outcome
Proportion (%) of favourable outcomes (GOSE 5-8)
Time frame: 6 month post injury
6 secondary outcomes
Mean and maximum hourly intracranial pressure (ICP)
Time frame: 36hrs post randomisation
Favourable outcomes (GOSE)
Time frame: 12 months post injury
Mean GOSE using ordinal logistic regression
Time frame: 6 months and 12 months
Mortality
Time frame: hospital, 6 months, 12 months
length of stay
Time frame: ICU admisssion
Brain metabolites using microdialysis (The Alfred Hospital only)
Time frame: During monitoring phase
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
D. J. Cooper principal investigator
The Alfred Hospital & National Trauma Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Early decompressive craniectomy in people with Brain Injuries, run by National Trauma Research Institute at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion (%) of favourable outcomes (GOSE 5-8) (time frame: 6 month post injury). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2020.