Head Injury TraumaNCT04574349
Decompressive Craniectomy Following Trauma
A study testing Decompressive craniectomy in people with Head Injury Trauma, run by Assiut University at 1 site in Egypt.
Trial summary
A prospective clinical trial on trauma patients with increased intracranial pressure(ICP) applied for decompressive craniectomy to lower ICP Read more about this study
- Who is it for?
- Ages Up to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Head Injury Trauma
- What is being tested?
- Decompressive craniectomy
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2020to 1 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Conditions
- Head Injury Trauma
- Being tested
- Decompressive craniectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decompressive craniectomyProcedure or surgery
Removing part of the skull (bone flap) to lower intracranial pressure
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of the patient's condition clinically
Clinically: Change of Glasgow Coma Scale (GCS). Maximum value is 15 Minimum value is 3
Measured: one year
Change of the patient's condition radiologically
By CT brain
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2020
- Study start1 Oct 2020 (estimated)
- Primary completion1 Oct 2021 (estimated)
- Study completion1 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Head Injury TraumaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa Eldeen Mohamed Oreaby Adam, Assiut University
- Investigators
- Roshdy A Elkhayat, Professor, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04574349
- Sponsor's protocol ID
- Decompressive craniectomy
- Status last verified
- Sep 2020
- First submitted
- 26 Sep 2020
- Last updated
- 5 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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 at a glance
From the registry record, last updated by the sponsor on 5 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Decompressive Craniectomy Following Traumatic Brain Injury: One Year Study
- ClinicalTrials.gov ID
- NCT04574349
- Acronym / sponsor ID
- Decompressive craniectomy
- Conditions
- Head Injury Trauma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2020 (estimated)
- Primary completion
- 1 Oct 2021 (estimated)
- Study completion
- 1 Oct 2021 (estimated)
- First posted
- 5 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- Up to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- Age: more than 60
- Old trauma
- Unfit for surgery (ex: cardiac patient)
- GCS < 8
- Midline shift less than 5 mm.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Decompressive craniectomyRemoving part of the skull (bone flap) to lower intracranial pressure | Procedure or surgery | – |
Primary outcome
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
Change of the patient's condition radiologically
Time frame: One year
By CT brain
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2020.
- Background1. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roshdy A Elkhayat, Professor principal investigator
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Decompressive craniectomy in people with Head Injury Trauma, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alaa M Oreaby (01008798181, alaaoreaby@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of the patient's condition clinically (time frame: one year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04574349, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2020.