Severe Traumatic Brain InjuryNCT06363474
Cisternostomy Vs Decompressive Craniectomy for Severe Traumatic Brain Injury
A study testing Decompressive Craniectomy and Cisternostomy in people with Severe Traumatic Brain Injury, run by University of Health Sciences Lahore.
Trial summary
The objective of this clinical study is to compare the outcomes of two neurosurgical interventions, Cisternostomy and Decompressive Craniectomy (DC), for the management of severe Traumatic Brain Injury (TBI), assessed using the Glasgow Outcome Scale (GOS). Read more about this study
- Who is it for?
- Ages Up to 60 years
- Conditions the study is for
- Severe Traumatic Brain Injury
- What is being tested?
- Decompressive Craniectomy and Cisternostomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 190 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2024to 1 May 2025
- 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
- No healthy volunteers
- Child, Adult
Who may be able to join
- Unilateral mass effects such as an acute subdural haematoma greater than 10mm or a midline shift greater than 5mm on computed tomographic (CT) post-trauma.
- Refractory ICP despite medical management (based on intracranial pressure monitoring.
- GCS >5 and <10 following traumatic head injury
- Age < 60 years
Who cannot join
- Brainstem dysfunction and signs of irreversible brain damage ( i.e bilaterally non-reactive pupils)
- Severe haemodynamic instability ( i.e polytrauma)
- Bleeding diathesis
- Previous head injury
- Malignant pathology
- Previous cranial surgery
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Cisternostomy Vs Decompressive Craniectomy for Severe Traumatic Brain Injury: Functional Outcome Comparison Using Glasgow Outcome Scale
The objective of this clinical study is to compare the outcomes of two neurosurgical interventions, Cisternostomy and Decompressive Craniectomy (DC), for the management of severe Traumatic Brain Injury (TBI), assessed using the Glasgow Outcome Scale (GOS). Severe TBI presents challenges in managing intracranial pressure (ICP) and cerebral perfusion, often requiring surgical intervention. DC involves the removal of a section of the skull to reduce ICP, while Cisternostomy, a technique rooted in microsurgery, aims to alleviate brain edema and lower ICP by creating additional space for cerebrospinal fluid (CSF) circulation.
This prospective study will be conducted at the Department of Neurosurgery, Punjab Institute of Neurosciences, Lahore. Patients meeting inclusion criteria will be randomized into Group A (DC) and Group B (Cisternostomy) following brain CT scans. Clinical evaluation will include regular follow-ups for 6 months post-surgery, recording data on GOS, duration of mechanical ventilation, ICU, and hospital stays. Analysis will be performed using SPSS 24, comparing outcomes between groups using Chi-square test and t-test. A significance level of p≤0.05 will be applied.
It is hypothesized that Cisternostomy, as an adjunct to traditional TBI management, will effectively reduce ICP, resulting in improved GOS and reduced complications postoperatively, including decreased duration of mechanical ventilation and ICU stay, with sustained improvement observed at 6 months
Read the detailed description
Traumatic brain injury (TBI) remains a major public health problem globally. Indications for neurosurgical interventions following TBI can be broadly categorised as 1) evacuation of haematoma, 2) control of traumatic intracranial pressure (ICP), 3) elevation of depressed skull, 4) repair of skull base fractures with or without dural repair, 5) treatment of hydrocephalus and 6) cranial reconstruction. Decompressive craniectomy (DC) is a neurosurgical procedure that involves the removal of a section of the skull (bone flap) and expansion duraplasty which provides additional space for the swollen brain to expand, leading to a reduction in ICP and maintained or improved cerebral perfusion pressure. As an adjunct, Cisternal opening is a well-embedded microsurgical technique in neurosurgical practice for vascular and skull base pathologies. Its application in the context of TBI, in combination with insertion of an external drain which stays in place for a few days post-operatively, has been termed cisternostomy. The objective of this study is to compare the outcome of Cisternostomy and DC for the management of severe TBI in terms of the Glasgow outcome scale (GOS). For these two groups meeting the inclusion criteria will be divided based on the lottery method after a CT scan of the brain. Group A (DC) and Group B (Cisternostomy) for severe TBI. The rationale of the procedure lies in the recognition of the important contribution of the perivascular Virchow - Robin spaces to CSF circulation. In severe TBI, increases the inter-cisternal pressure that provokes a shift of fluid from the cisternal compartment to the brain parenchyma. Although DC brings the ICP to atmospheric pressure, it does not counter react the intracerebral pressure, which causes severe brain swelling and herniation. DC may further necessitate an additional operation for cranial reconstruction, termed as cranioplasty. In this situation, cisternostomy is useful in reversing this fluid shift alleviating brain edema and thereby lowering ICP. A standard ventricular drain will be placed in the cisternal compartment which will further help in controlling the raised ICP. This study will be conducted at the Department of Neurosurgery, Punjab Institute of Neurosciences, Lahore. Clinical evaluation of the patient will be done with regular follow-up for 6 months. Data of the GOS, duration on Ventilator, ICU stay and hospital stay along with extended GOS at 6 months will be recorded and analysed. It is expected that the cisternostomy technique 3 can be considered as an adjuvant surgical strategy for severe TBI effective in reducing ICP with good GOS and a low rate of complications in the postoperative period following cisternostomy, decreased number of days on a ventilator and ICU stay with good GOS at 6 months. Performing a cisternostomy demands specific instruments and expertise in skull base and vascular surgery, making its widespread use in trauma care centers challenging. Data will be collected and analyzed by using the SPSS 24 version. Quantitative variables such as age and demographic variables will be described as Mean +/- SD for both groups. Comparison of both groups for the surgical outcome will be done by using the Chi-square test and t-test according to the nature of outcome variables. The P-value of equal or less than 0.05 will be considered significant.
- Conditions
- Severe Traumatic Brain Injury
- Being tested
- Decompressive Craniectomy, Cisternostomy
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decompressive CraniectomyProcedure or surgery
Patients allocated to this arm will undergo decompressive craniectomy, which involves the surgical removal of a section of the skull (bone flap). This procedure is performed to alleviate intracranial pressure (ICP) by providing additional space for the swollen brain to expand. The surgery will be performed by a single surgical team under general anesthesia. After the procedure, patients will be closely monitored for various parameters including duration on mechanical ventilation, duration of ICU stay, duration of hospital stay, and Glasgow Outcome Scale (GOS) at the time of discharge.
CisternostomyProcedure or surgery
Patients allocated to this arm will undergo cisternostomy, a microsurgical technique used in neurosurgery. Cisternostomy involves the creation of an additional space for cerebrospinal fluid (CSF) circulation to alleviate brain edema and lower intracranial pressure (ICP). The surgery will be performed by the same surgical team under general anesthesia. Following the procedure, patients will be monitored for various parameters including duration on mechanical ventilation, duration of ICU stay, duration of hospital stay, and Glasgow Outcome Scale (GOS) at the time of discharge.
| Study group | Role | What they receive |
|---|---|---|
| Group A - Decompressive Craniectomy | Experimental | Patients allocated to Group A will undergo decompressive craniectomy, a neurosurgical procedure involving the removal of a section of the skull (bone flap). This procedure aims to alleviate intracranial pressure (ICP) and provide additional space for the swollen brain to expand. The surgery will be performed by a single surgical team under general anesthesia. Following the procedure, patients will be closely monitored for various parameters including duration on mechanical ventilation, duration of ICU stay, duration of hospital stay, and Glasgow Outcome Scale (GOS) at the time of discharge. Receives: Procedure: Decompressive Craniectomy |
| Group B - Cisternostomy | Active comparator | Arm Description: Patients allocated to Group B will undergo cisternostomy, a microsurgical technique used in neurosurgery. This procedure involves the creation of an additional space for cerebrospinal fluid (CSF) circulation to alleviate brain edema and lower intracranial pressure (ICP). The surgery will be performed by the same surgical team under general anesthesia. Postoperatively, patients will be monitored for various parameters including duration on mechanical ventilation, duration of ICU stay, duration of hospital stay, and Glasgow Outcome Scale (GOS) at the time of discharge. Receives: Procedure: Cisternostomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
comparison of patient outcomes between the two intervention groups (Decompressive Craniectomy and Cisternostomy) in terms of the Glasgow Outcome Scale (GOS).
The primary outcome of this study is the comparison of patient outcomes between the two intervention groups (Decompressive Craniectomy and Cisternostomy) in terms of the Glasgow Outcome Scale (GOS).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2024
- Study start1 May 2024 (estimated)
- Primary completion1 May 2025 (estimated)
- Study completion1 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Traumatic Brain InjuryStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The intervention model of this study is a parallel model. Patients meeting inclusion criteria are enrolled from the neurosurgery department of Punjab Institute of Neurosciences, Lahore. After obtaining consent, patients undergo detailed assessments and investigations. They're randomly assigned to Group A (decompressive craniectomy) or Group B (cisternostomy). Both procedures are performed by a single surgical team under anesthesia. Postoperatively, patients are monitored for mechanical ventilation duration, ICU and hospital stay lengths, and Glasgow Outcome Scale at discharge. This model enables outcome comparison between intervention groups while controlling confounding variables.
- Masking
- None (open label)
- Enrolment
- 190 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Health Sciences Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Mustapha Shesh, University of Health Sciences Lahore
- Investigators
- DR. MUSTAPHA SHESH, MS Neurosugery, Principal investigator, University of Health Sciences Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06363474
- Sponsor's protocol ID
- UHS 5532
- Status last verified
- Apr 2024
- First submitted
- 9 Apr 2024
- Last updated
- 12 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cisternostomy Vs Decompressive Craniectomy for Severe Traumatic Brain Injury: Functional Outcome Comparison Using Glasgow Outcome Scale
- ClinicalTrials.gov ID
- NCT06363474
- Acronym / sponsor ID
- UHS 5532
- Conditions
- Severe Traumatic Brain Injury
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 190 participants (estimated)
- Lead sponsor
- University of Health Sciences LahoreUniversity, hospital or other
- Study start
- 1 May 2024 (estimated)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 1 May 2025 (estimated)
- First posted
- 12 Apr 2024 (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.
The objective of this clinical study is to compare the outcomes of two neurosurgical interventions, Cisternostomy and Decompressive Craniectomy (DC), for the management of severe Traumatic Brain Injury (TBI), assessed using the Glasgow Outcome Scale (GOS). Severe TBI presents challenges in managing intracranial pressure (ICP) and cerebral perfusion, often requiring surgical intervention. DC involves the removal of a section of the skull to reduce ICP, while Cisternostomy, a technique rooted in microsurgery, aims to alleviate brain edema and lower ICP by creating additional space for cerebrospinal fluid (CSF) circulation.
This prospective study will be conducted at the Department of Neurosurgery, Punjab Institute of Neurosciences, Lahore. Patients meeting inclusion criteria will be randomized into Group A (DC) and Group B (Cisternostomy) following brain CT scans. Clinical evaluation will include regular follow-ups for 6 months post-surgery, recording data on GOS, duration of mechanical ventilation, ICU, and hospital stays. Analysis will be performed using SPSS 24, comparing outcomes between groups using Chi-square test and t-test. A significance level of p≤0.05 will be applied.
It is hypothesized that Cisternostomy, as an adjunct to traditional TBI management, will effectively reduce ICP, resulting in improved GOS and reduced complications postoperatively, including decreased duration of mechanical ventilation and ICU stay, with sustained improvement observed at 6 months
Detailed description
Traumatic brain injury (TBI) remains a major public health problem globally. Indications for neurosurgical interventions following TBI can be broadly categorised as 1) evacuation of haematoma, 2) control of traumatic intracranial pressure (ICP), 3) elevation of depressed skull, 4) repair of skull base fractures with or without dural repair, 5) treatment of hydrocephalus and 6) cranial reconstruction. Decompressive craniectomy (DC) is a neurosurgical procedure that involves the removal of a section of the skull (bone flap) and expansion duraplasty which provides additional space for the swollen brain to expand, leading to a reduction in ICP and maintained or improved cerebral perfusion pressure. As an adjunct, Cisternal opening is a well-embedded microsurgical technique in neurosurgical practice for vascular and skull base pathologies. Its application in the context of TBI, in combination with insertion of an external drain which stays in place for a few days post-operatively, has been termed cisternostomy. The objective of this study is to compare the outcome of Cisternostomy and DC for the management of severe TBI in terms of the Glasgow outcome scale (GOS). For these two groups meeting the inclusion criteria will be divided based on the lottery method after a CT scan of the brain. Group A (DC) and Group B (Cisternostomy) for severe TBI. The rationale of the procedure lies in the recognition of the important contribution of the perivascular Virchow - Robin spaces to CSF circulation. In severe TBI, increases the inter-cisternal pressure that provokes a shift of fluid from the cisternal compartment to the brain parenchyma. Although DC brings the ICP to atmospheric pressure, it does not counter react the intracerebral pressure, which causes severe brain swelling and herniation. DC may further necessitate an additional operation for cranial reconstruction, termed as cranioplasty. In this situation, cisternostomy is useful in reversing this fluid shift alleviating brain edema and thereby lowering ICP. A standard ventricular drain will be placed in the cisternal compartment which will further help in controlling the raised ICP. This study will be conducted at the Department of Neurosurgery, Punjab Institute of Neurosciences, Lahore. Clinical evaluation of the patient will be done with regular follow-up for 6 months. Data of the GOS, duration on Ventilator, ICU stay and hospital stay along with extended GOS at 6 months will be recorded and analysed. It is expected that the cisternostomy technique 3 can be considered as an adjuvant surgical strategy for severe TBI effective in reducing ICP with good GOS and a low rate of complications in the postoperative period following cisternostomy, decreased number of days on a ventilator and ICU stay with good GOS at 6 months. Performing a cisternostomy demands specific instruments and expertise in skull base and vascular surgery, making its widespread use in trauma care centers challenging. Data will be collected and analyzed by using the SPSS 24 version. Quantitative variables such as age and demographic variables will be described as Mean +/- SD for both groups. Comparison of both groups for the surgical outcome will be done by using the Chi-square test and t-test according to the nature of outcome variables. The P-value of equal or less than 0.05 will be considered significant.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The intervention model of this study is a parallel model. Patients meeting inclusion criteria are enrolled from the neurosurgery department of Punjab Institute of Neurosciences, Lahore. After obtaining consent, patients undergo detailed assessments and investigations. They're randomly assigned to Group A (decompressive craniectomy) or Group B (cisternostomy). Both procedures are performed by a single surgical team under anesthesia. Postoperatively, patients are monitored for mechanical ventilation duration, ICU and hospital stay lengths, and Glasgow Outcome Scale at discharge. This model enables outcome comparison between intervention groups while controlling confounding variables.
| Arm | Type | Receives |
|---|---|---|
| Group A - Decompressive Craniectomy | Experimental | Procedure: Decompressive CraniectomyPatients allocated to Group A will undergo decompressive craniectomy, a neurosurgical procedure involving the removal of a section of the skull (bone flap). This procedure aims to alleviate intracranial pressure (ICP) and provide additional space for the swollen brain to expand. The surgery will be performed by a single surgical team under general anesthesia. Following the procedure, patients will be closely monitored for various parameters including duration on mechanical ventilation, duration of ICU stay, duration of hospital stay, and Glasgow Outcome Scale (GOS) at the time of discharge. |
| Group B - Cisternostomy | Active comparator | Procedure: CisternostomyArm Description: Patients allocated to Group B will undergo cisternostomy, a microsurgical technique used in neurosurgery. This procedure involves the creation of an additional space for cerebrospinal fluid (CSF) circulation to alleviate brain edema and lower intracranial pressure (ICP). The surgery will be performed by the same surgical team under general anesthesia. Postoperatively, patients will be monitored for various parameters including duration on mechanical ventilation, duration of ICU stay, duration of hospital stay, and Glasgow Outcome Scale (GOS) at the time of discharge. |
Who may qualify
- Ages
- Up to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Unilateral mass effects such as an acute subdural haematoma greater than 10mm or a midline shift greater than 5mm on computed tomographic (CT) post-trauma.
- Refractory ICP despite medical management (based on intracranial pressure monitoring.
- GCS >5 and <10 following traumatic head injury
- Age < 60 years
Key exclusion criteria (6 listed)
- Brainstem dysfunction and signs of irreversible brain damage ( i.e bilaterally non-reactive pupils)
- Severe haemodynamic instability ( i.e polytrauma)
- Bleeding diathesis
- Previous head injury
- Malignant pathology
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 CraniectomyPatients allocated to this arm will undergo decompressive craniectomy, which involves the surgical removal of a section of the skull (bone flap). This procedure is performed to alleviate intracranial pressure (ICP) by providing additional space for the swollen brain to expand. The surgery will be performed by a single surgical team under general anesthesia. After the procedure, patients will be closely monitored for various parameters including duration on mechanical ventilation, duration of ICU stay, duration of hospital stay, and Glasgow Outcome Scale (GOS) at the time of discharge. | Procedure or surgery | Group A - Decompressive Craniectomy |
| CisternostomyPatients allocated to this arm will undergo cisternostomy, a microsurgical technique used in neurosurgery. Cisternostomy involves the creation of an additional space for cerebrospinal fluid (CSF) circulation to alleviate brain edema and lower intracranial pressure (ICP). The surgery will be performed by the same surgical team under general anesthesia. Following the procedure, patients will be monitored for various parameters including duration on mechanical ventilation, duration of ICU stay, duration of hospital stay, and Glasgow Outcome Scale (GOS) at the time of discharge. | Procedure or surgery | Group B - Cisternostomy |
Primary outcome
comparison of patient outcomes between the two intervention groups (Decompressive Craniectomy and Cisternostomy) in terms of the Glasgow Outcome Scale (GOS).
Time frame: 12 months
The primary outcome of this study is the comparison of patient outcomes between the two intervention groups (Decompressive Craniectomy and Cisternostomy) in terms of the Glasgow Outcome Scale (GOS).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2024.
- Individual participant dataSharing planned: No
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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.
DR. MUSTAPHA SHESH, MS Neurosugery principal investigator
University of Health Sciences Lahore
Questions about this trial
What is this clinical trial studying?
A study testing Decompressive Craniectomy and Cisternostomy in people with Severe Traumatic Brain Injury, run by University of Health Sciences Lahore.
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 12 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
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 Dr. Mustapha Shesh, MSNeurosugery (03166951158, sheshmustapha@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
comparison of patient outcomes between the two intervention groups (Decompressive Craniectomy and Cisternostomy) in terms of the Glasgow Outcome Scale (GOS). (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Apr 2024.