Condition category
Injury, Occupational Diseases, Poisoning
Date applied
10/02/2009
Date assigned
03/04/2009
Last edited
04/05/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Wusi Qiu

ORCID ID

Contact details

126 Wengzhou Road
Department of Neurosurgery
Hangzhou Second Hospital
College of Medicine
Hangzhou Normal University
Hangzhou
310015
China

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

Sponsor information

Organisation

Zhejiang and Hangzhou Health Department (China)

Sponsor details

2 Xiaonv Road
Hangzhou
310009
China

Sponsor type

Government

Website

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

  1. 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.

Additional files

Editorial Notes