Decompressive Craniectomy Following Trauma

Study Overview
=================
Brief Summary
-----------------
A prospective clinical trial on trauma patients with increased intracranial pressure(ICP) applied for decompressive craniectomy to lower ICP

Detailed Description
-----------------
Traumatic brain injury (TBI) remains a major health problem across the globe . Intracranial pressure (ICP) following TBI can be elevated due to increasing mass effect from hematomas, contusions, and diffuse brain swelling. Decompressive craniectomy (DC) is a surgical procedure which involves removing a large part of the skull (bone flap) out to make more room for the swollen brain.Mass lesions can be acute subdural hematoma (ASDH), intraparenchymal, brain oedema, or a combination thereof. The most frequent indication for a DC is an acute subdural hematoma (ASDH). The first modern use of DC following TBI was done by Harvey Cushing in 1908. Cushing treated head-injured patients with a subtemporal DC and he reported a substantial reduction in mortality. The management of TBI progressed significantly in the 21st century due to advances in neuroimaging, prehospital management, neurointensive care, neuroanaesthesia, and rehabilitation. This led to a renaissance of interest in DC for improvement patient conditions. One of the serious concerns regarding DC is that it may reduce mortality, but increase the subset of patients with severe disability and persistent vegetative state. The discrepancy in published outcome may, to some extent, be explained by difference in patient selection, indications, timing , and technique of surgery. In terms of surgical consideration regarding DC, it is now well accepted that the dura mater has to be opened and the minimum diameter of unilateral DC should be around 11-12 cm. Skull reconstruction (cranioplasty) after improvement of neurological state is recommended. Decompressive craniectomy provides additional space for the swollen brain and can effectively reduce ICP, thereby mitigating the risk of herniation. However, despite the positive effect of DC on uncontrollable intracranial hypertension, the effect of surgical decompression in mortality and overall functional outcome following TBI remained controversial.

Official Title
-----------------
Effect of Decompressive Craniectomy Following Traumatic Brain Injury: One Year Study

Conditions
-----------------
Head Injury Trauma

Intervention / Treatment
-----------------
* Procedure: Decompressive craniectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All Patients with signs of increased intracranial tension (subdural hematoma, brain edema, intracerebral hematoma) after trauma diagnosed clinically, radiologically, and resistant to medical decompression. Age: up to 60 Midline shift more than 5 mm. GCS > 8 Exclusion Criteria: Age: more than 60 Old trauma Unfit for surgery (ex: cardiac patient) GCS < 8 Midline shift less than 5 mm. Unwillingness to participate in the study.

Ages Eligible for Study
-----------------
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Decompressive craniectomy|Removing part of the skull (bone flap) to lower intracranial pressure|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of the patient's condition clinically | Clinically: Change of Glasgow Coma Scale (GCS). Maximum value is 15 Minimum value is 3 | one year | 
| Change of the patient's condition radiologically | By CT brain | One year |