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

Completed

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

Registration Number: ISRCTN14110527

Lead Sponsor: Zhejiang and Hangzhou Health Department (China)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 80

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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. <br>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

Name	Time	Method
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<br>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