Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
2008R40G2150132
Study information
Scientific title
Study of the effectiveness of craniotomy (Decompressive Craniectomy [DC] or routine temporoparietal craniectomy) on patients with Acute post-traumatic Brain Swelling after severe traumatic brain injury: a single-centre, prospective randomised, controlled, double-blind trial
Acronym
DCABS
Study hypothesis
The aim of the present clinical study was to assess the efficacy of craniotomy, decompressive craniectomy (DC) or routine temporoparietal craniectomy, on patients with acute post-traumatic brain swelling (BS). We assume that DC has superior effectiveness on patients with acute BS after severe traumatic brain injury.
Ethics approval
Institutional Review Board and the ethical committees of Clinical Medical College of Hangzhou gave approval on the 1st September 2002 (ref: 200203)
Study design
Single-centre prospective randomised controlled double-blind trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Acute post-traumatic brain swelling
Intervention
Based on the guidelines for the management of severe head injury set forth by the Joint Section on Neurotrauma and Critical Care of the Brain Trauma Foundation and the American Association of Neurological Surgeons, all patients underwent lateral craniotomy within 24 hours after injury and other medical management such as dehydration with mannitol (average amount received in subsequent 6-hour period was 20% mannitol 125 ml) and routine pharmacological or physical measures adopted to maintain normal body temperature after diagnosis of post-traumatic BS accordingly.
The surgery mode of DC was elective at the frontoparietotemporal region, based on the lesion location and midline shift determined by CT scans. Briefly, the bone window was about 15 cm in diameter with duraplasty using expanded dura substitute when necessary. The anterior was frontal to the midpupillary lines, and the posterior line was about 3 - 4 cm posterior to the external acustic meatus. The superior line was 2 cm of the lateral edge of the superior sagittal sinus, and the inferior line was extended below the level of the zygomatic arch, so that the frontal and temporal base could be explored. Durotomy was performed over the entire region of bony decompression as a stellate shape. Cranioplasty was performed after 3 months.
Post-operative therapy was similar with those previously described, which included keeping respiratory tract unobstructed (with assisted ventilation to ensure arterial O2 saturation (SaO2) greater than or equal to 95% against hypoxia and partial pressure of carbon dioxide in arterial blood (PaCO2) maintained near 40mm Hg at 37°C), intubations if necessary, controlling the blood glucose level and body temperature and balancing water and electrolyte, dehydration and diuresis, homeostasis balanced, anti-infection with sensitive antibiotics and so on.
The control group received the unilateral routine temporoparietal craniectomy and the operation site depended on the location of injury and midline shift accordingly. The bone window diametered about 8 cm and the dura mater was also fixed at the edge with duraplasty, and the bone was re-implanted after 3 - 6 months. In the routine craniotomy group, post-operative treatment was similar with those in the DC group.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
1. Intracranial pressure (ICP) - continuous recording of ICP was applied in all patients for 96 hours with the ICP monitor system (Camino-MPM1, Integra LifeSciences CO, USA). A cranial hole was drilled, if necessary, and the drainage catheter was induced 5 cm or so into right lateral ventricles via the level of the anterior horn. The intraventricular (intracerebral) pressure probe (Camino-110-4B) was placed at the level of foramen of Momro during craniotomy.
2. Glasgow Outcome Scale (GOS) scores, from 1 to 5 respectively, according to: death, vegetable state, severe disability, moderate disability, mild or no disability, evaluated at 1 years follow-up after injury
Secondary outcome measures
1. Vital signs (temperature, heart rate, breathing rate and blood pressure), arterial oxygen saturation with the multiple monitor (Model NO: 90309, Space Lab, Medical. Inc. USA) recorded every 12 hours for 7 days after craniotomy
2. Complications, mainly inclusive of delayed intracranial haematoma, pulmonary infection, digestive tract haemorrhage, and electrolytes disorders (beyond the normal serum concentrations of Na+, Cl-, Mg2+, K+, P3+ and Ca2+), recorded every 12 hours for 7 days, 24 hours for another 7 days after craniotomy
Overall trial start date
01/01/2003
Overall trial end date
01/12/2008
Reason abandoned
Eligibility
Participant inclusion criteria
1. Aged from 18 to 65 years, either sex
2. A history of traumatic brain injury
3. Glasgow Coma Score (GCS) less than or equal to 8 at admission
4. Computed tomography (CT) scans: swollen hemisphere (with midline shift greater than 5 mm, compressed basal cisterns) within 24 hours after trauma
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
80
Participant exclusion criteria
1. Patients younger than 19 or older than 65 years
2. Multiply-injured patients without sufficient resuscitation
3. With any previous disabling neurological disease
4. Intracerebral haematoma of more than 3 cm in diameter
5. Spinal cord injury
6. Penetrating brain injury
7. Fixed dilated pupils and GCS score of 3 with no chance of survival
Recruitment start date
01/01/2003
Recruitment end date
01/12/2008
Locations
Countries of recruitment
China
Trial participating centre
126 Wengzhou Road
Hangzhou
310015
China
Funders
Funder type
Government
Funder name
Zhejiang and Hangzhou Health Department (China) - Scientific Research Fund (ref: 2009)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2010 results in http://www.ncbi.nlm.nih.gov/pubmed/19930556
Publication citations
-
Results
Qiu W, Guo C, Shen H, Chen K, Wen L, Huang H, Ding M, Sun L, Jiang Q, Wang W, Effects of unilateral decompressive craniectomy on patients with unilateral acute post-traumatic brain swelling after severe traumatic brain injury., Crit Care, 2009, 13, 6, R185, doi: 10.1186/cc8178.