Study of the effectiveness of craniotomy on patients with acute post-traumatic brain swelling after severe traumatic brain injury

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN14110527

Enrollment

Registered

2009-04-03

Start date

2003-01-01

Completion date

Unknown

Last updated

2015-01-13

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

Conditions

Acute post-traumatic brain swelling Injury, Occupational Diseases, Poisoning Intracranial injury

Interventions

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 Neurolog

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

China

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Apr 1, 2026