Decompressive Craniectomy Following Trauma

Head Injury Trauma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04574349
• Other study ID #: Decompressive craniectomy
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 1, 2020
• Est. completion date: October 1, 2021

Study information

• Verified date: September 2020
• Source: Assiut University
• Contact: Alaa M Oreaby
• Phone: 01008798181
• Email: alaaoreaby[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A prospective clinical trial on trauma patients with increased intracranial pressure(ICP) applied for decompressive craniectomy to lower ICP

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: October 1, 2021
• Est. primary completion date: October 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Craniocerebral Trauma
• Head Injury Trauma

Intervention

Procedure:
• Decompressive craniectomy
Removing part of the skull (bone flap) to lower intracranial pressure

Locations

Country	Name	City	State
Egypt	Assiut University	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

1. Wilson MH, Kolias AG, Hutchinson PJ. Neurotrauma - a multidisciplinary disease. Int J clic pract 2014;68:5-7. 2. Kolias AG, Kirkpatrick PJ, Hutchinson PJ. Decompressive craniectomy: past, present, and future. Nat Rev Neurol 2013;9:405-15. 3. Sahuquillo J, Arikan F. Decompressive craniecomty for the treatment of refractory high intracranial pressure in traumatic brain injury. Cochrane Database Syst Rev 2010;CD003983. 4. Cushing G. I. subtemporal Decompressive Opertions for the intracranial Complications Associated with Bursting Fractures of the Skull. Ann Surg 1908;47:641-4.1 5. Polin RS, Shaffrey ME, Bogaev, et al. Decompressive bifrontal craniectomy in the treatment of severe refractory posttraumatic cerebral edema. Neurosugery 2015;41:84-92. 6. Whitfield PC, Patel H, Hutchinson PJ, et al. Bifrontal decompressive craniectomy in the management of posttraumatic intracranial hypertension. Br J Neurosurg 2014;15:500-7. 7. De luca GP, Volpin L, Fornezza U, Cervellini P, Zanusso M, Casentini L, Curri D, Piacentino M, Bozzato G, Colombo F, The role of decompressive craniectomy in the treatment of uncontroolable pos-traumatic intracranial hypertension. Acta Neurichir (Suppl) 2000;76:401-404. 8. Faul, F., Erdfelder, E., Lang, A.-G. & Buchner, A. G*Power 3: A flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behavior Research Methods, 2014;39, 175-191.. 9. I. Timofeev, P.J.Kirkpatrick, E.Corteen, M.Hiller, M.Czosnyka, D.K.Menon, J.D.Pickard, and P.J.Hutchinson Decompressive craniectomy in traumatic brain injury 2006;96:11-16 10. Teasdale G, Jennett B. Assessment of coma and impaired consciousness. Lancet 1974; 81-84 11. Teasdale G, Jennett B. Assessment and prognosis of coma after head injury. Acta Neurochir 1976; 34:45-55.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of the patient's condition clinically	Clinically: Change of Glasgow Coma Scale (GCS). Maximum value is 15 Minimum value is 3	one year
Primary	Change of the patient's condition radiologically	By CT brain	One year