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Decompressive Craniectomy Following Trauma

Primary Purpose

Head Injury Trauma

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Decompressive craniectomy
Sponsored by
Assiut University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head Injury Trauma

Eligibility Criteria

undefined - 60 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Assiut University

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
September 26, 2020
Last Updated
September 30, 2020
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT04574349
Brief Title
Decompressive Craniectomy Following Trauma
Official Title
Effect of Decompressive Craniectomy Following Traumatic Brain Injury: One Year Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2020 (Anticipated)
Primary Completion Date
October 1, 2021 (Anticipated)
Study Completion Date
October 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head Injury Trauma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Decompressive craniectomy
Intervention Description
Removing part of the skull (bone flap) to lower intracranial pressure
Primary Outcome Measure Information:
Title
Change of the patient's condition clinically
Description
Clinically: Change of Glasgow Coma Scale (GCS). Maximum value is 15 Minimum value is 3
Time Frame
one year
Title
Change of the patient's condition radiologically
Description
By CT brain
Time Frame
One year

10. Eligibility

Sex
All
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alaa M Oreaby
Phone
01008798181
Email
alaaoreaby@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roshdy A Elkhayat, Professor
Organizational Affiliation
Assiut University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assiut University
City
Assiut
Country
Egypt

12. IPD Sharing Statement

Citations:
Citation
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.
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Decompressive Craniectomy Following Trauma

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