Decompressive Craniectomy Following Trauma

Not Applicable

• Conditions: Head Injury Trauma

• Registration Number: NCT04574349
• Lead Sponsor: Assiut University

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.

Study Timeline

• Status Verified: 2020-09
• Study First Submitted: 2020-09-26
• Study First Submitted QC: 2020-09-30
• Last Update Submitted: 2020-09-30
• Study Start: 2020-10-01
• Study First Posted: 2020-10-05
• Last Update Posted: 2020-10-05
• Primary Completion: 2021-10-01
• Study Completion: 2021-10-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change of the patient's condition clinically	one year	Clinically: Change of Glasgow Coma Scale (GCS). Maximum value is 15 Minimum value is 3
Change of the patient's condition radiologically	One year	By CT brain

Trial Locations

Locations (1)

Assiut University; 🇪🇬 Assiut, Egypt