- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04574349
Decompressive Craniectomy Following Trauma
September 30, 2020 updated by: Alaa Eldeen Mohamed Oreaby Adam, Assiut University
Effect of Decompressive Craniectomy Following Traumatic Brain Injury: One Year Study
A prospective clinical trial on trauma patients with increased intracranial pressure(ICP) applied for decompressive craniectomy to lower ICP
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Assiut, Egypt
- Assiut University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 60 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of the patient's condition clinically
Time Frame: one year
|
Clinically: Change of Glasgow Coma Scale (GCS).
Maximum value is 15 Minimum value is 3
|
one year
|
Change of the patient's condition radiologically
Time Frame: One year
|
By CT brain
|
One year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Roshdy A Elkhayat, Professor, Assiut University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
October 1, 2020
Primary Completion (Anticipated)
October 1, 2021
Study Completion (Anticipated)
October 1, 2021
Study Registration Dates
First Submitted
September 26, 2020
First Submitted That Met QC Criteria
September 30, 2020
First Posted (Actual)
October 5, 2020
Study Record Updates
Last Update Posted (Actual)
October 5, 2020
Last Update Submitted That Met QC Criteria
September 30, 2020
Last Verified
September 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Decompressive craniectomy
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Head Injury Trauma
-
Chi-Ming HuangUMKC School of MedicineNot yet recruitingConcussion | Head Injury Trauma
-
Wake Forest University Health SciencesMind and Life Institute, Hadley, MassachusettsCompleted
-
Duke UniversityCompletedHead Injuries, Closed | Head Trauma | Head Injuries | Craniocerebral Injuries | Crushing Skull Injury | Head Injuries, Multiple | Head Trauma,Closed | Head Trauma Injury | Head Trauma, Penetrating | Head Injury, Minor | Head Injury Major | Head Injury, Open | Injuries, Craniocerebral | Injuries, Head | Multiple Head... and other conditionsUnited States
-
University of PittsburghCompletedHead Injury, MinorUnited States
-
Duke UniversityCompletedHead Injuries, Closed | Head Trauma | Head Injuries | Craniocerebral Injuries | Crushing Skull Injury | Head Injuries, Multiple | Head Trauma,Closed | Head Trauma Injury | Head Trauma, Penetrating | Head Injury, Minor | Head Injury Major | Head Injury, Open | Injuries, Craniocerebral | Injuries, Head | Multiple Head... and other conditionsUnited States, Uganda
-
Groupe Hospitalier Paris Saint JosephCompleted
-
University Hospital, CaenUnknown
-
Centre Hospitalier Universitaire DijonCompleted
-
Makerere UniversityCompletedSevere Head InjuryUganda
-
The Hospital for Sick ChildrenCanadian Institutes of Health Research (CIHR)UnknownWounds and Injuries | Closed Head InjuryCanada
Clinical Trials on Decompressive craniectomy
-
Southwest Hospital, ChinaUnknownIntracranial HemorrhagesChina
-
Technical University of MunichFederal Ministry of Defence (Germany); Bundesministerium der VerteidigungRecruitingTraumatic Brain InjuriesFrance, Germany
-
Fondation LenvalWithdrawnHypertension IntracranialFrance
-
Central Hospital, Nancy, FranceCompletedBrain Injuries | Treatment Outcome | Decompressive CraniectomyFrance
-
University Hospital, GenevaTerminatedStroke | Traumatic Brain Injury | Post-Op Complication | Post-Op Infection | Post Operative Hemorrhage | Trephined Syndrome | Sinking Skin Flap SyndromeSwitzerland
-
MiMedx Group, Inc.Completed
-
National Trauma Research InstituteNational Health and Medical Research Council, Australia; Victorian Trauma Foundation and other collaboratorsCompletedBrain InjuriesAustralia
-
Tang-Du HospitalUnknownSubarachnoid Hemorrhage, AneurysmalChina
-
Ege UniversityCompletedCerebellar Stroke
-
Charles University, Czech RepublicMilitary University Hospital, PragueRecruitingAcquired Brain Injury | Acute Subdural HematomaCzechia