Traumatic Brain HemorrhageNCT03971240
Traumatic Acute Subdural Haematoma: Management and Outcome
A study testing evacuation of traumatic acute subdural hematoma in people with Traumatic Brain Hemorrhage, run by Assiut University.
Trial summary
Traumatic acute subdural haematomas (ASDHs) are common pathological entity in neurosurgical practice . The frequency of (ASDHs) has been proposed as approximately 10-20% of patients admitted with traumatic brain injury(TBI) .Approximately two -thirds of patient with TBI undergoing emergency cranial surgery have an… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Traumatic Brain Hemorrhage
- What is being tested?
- evacuation of traumatic acute subdural hematoma
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2019to 31 Jan 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patients with traumatic ASDH with thickness greater than 10 mm on CTscan
- patients with traumatic ASDH associated with mid -line shift more than 5 mm on CT scan.
Who cannot join
- patients with blood diseases or defective coagulation.
- CT demonstrates associated other intracranial hematomas e.g. epidural , intracerebral or subarachenoid haemorrhage.
Trial locations and contacts
No sites are listed yet.
About this study
Traumatic acute subdural haematomas (ASDHs) are common pathological entity in neurosurgical practice . The frequency of (ASDHs) has been proposed as approximately 10-20% of patients admitted with traumatic brain injury(TBI) .Approximately two -thirds of patient with TBI undergoing emergency cranial surgery have an acute subdural haematoma evacuated . Two common causes of traumatic ASDH: accumulation of blood around parenchymal laceration , usually frontal and temporal lobes and there is usually severe underlying brain injury .The second cause is surface or bridging vessel torn from cerebral acceleration - deceleration during violent head motion .
Read the detailed description
Traumatic acute subdural haematomas (ASDHs) are common pathological entity in neurosurgical practice . The frequency of (ASDHs) has been proposed as approximately 10-20% of patients admitted with traumatic brain injury(TBI) .Approximately two -thirds of patient with TBI undergoing emergency cranial surgery have an acute subdural haematoma evacuated . Two common causes of traumatic ASDH: accumulation of blood around parenchymal laceration , usually frontal and temporal lobes and there is usually severe underlying brain injury .The second cause is surface or bridging vessel torn from cerebral acceleration - deceleration during violent head motion . These haematomas have been historically associated with high mortality rate (between 40-60%)(1).This high mortality rate has been attributed to the characteristic of haematoma itself , due to the primary insults to the brain like brain parenchymal injury , and to the secondary insults like hypoxia and hypotension in severe head injury patients .
Theoretically ,intracranial hypertension due to ASDH may lead to transtentorial cerebral herniation and secondary ischemic injury of the brain.CT scan is main and most informative investigatory aid in diagnosis of traumatic ASDH. The criteria used to select patients for non - operative management are clinical stability or improvement during the time from injury to evaluation at hospital , haematoma thickness less than 10 mm and mid line shift less than 5 mm in the initial CT. Surgery is indicated if on CT 1- ASDH with thickness > 10mm. or 2- Mid line shift >5mm.on CT 3- ASDH with thickness <10 mm and midline shift <5mm on CT should undergo surgical evaluation if (a) GCS drop by >_ 2 point from injury to admission .(b) and or pupils are asymmetric or fixed and dilated (7). Time of surgery for ASDH is matter of controversy. As general principle ,when surgery for ASDH is indicated it should be done as soon as possible . Regarding evacuation of acute subdural haematoma, procedures vary from single burrhole evacuation to craniotomies and decompressive procedures .Some advocated ASDH evacuations by decompressive craniectomy with dural - slits .
- Conditions
- Traumatic Brain Hemorrhage
- Being tested
- evacuation of traumatic acute subdural hematoma
- Medical subject headings
- Brain Hemorrhage, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
evacuation of traumatic acute subdural hematomaProcedure or surgery
craniotomy will be done with evacuation of the hematoma
| Study group | Role | What they receive |
|---|---|---|
| outcome of surgically evacuated traumatic ASDH | Experimental | we will operate patients with traumatic acute subdural hematoma with some criteria and evaluate the outcome of surgery Receives: Procedure: evacuation of traumatic acute subdural hematoma |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical outcome
evaluation of the clinical outcome by recording the the patients' outcome by modified rankin scale: G"0'' No disability at all. (+1) No significant disability despite symptoms, able to carry out all usual duties and activities.
(+2) Slight disability ,unable to carry out all previous activities, but able to look after own affairs without assistance.
(+3) Moderate disability, requiring some help, but able to walk without assistance.
(+4) Moderately severe disability, unable to walk and attend to bodily needs without assistance.
(+5) Severe disability, bedridden, incontinent and requiring constant nursing care attention.
(+6) Dead
Measured: within 6 weeks post operative
radiological outcome
radiological outcome assessment by CT brain scan by measuring the midline shift in millimeters ( mild midline shift if < 5mm , moderate if = 5 mm. and severe midline shift if > 5mm. )
Measured: one day post operative and within 6 weeks post operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2019
- Study start1 Sep 2019 (estimated)
- Primary completion31 Aug 2020 (estimated)
- Study completion31 Jan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain HemorrhageStudies 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
- 39 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Ahmed Ibrahim Alghriany, Assiut University
- Investigators
- mohamed alghriany, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03971240
- Sponsor's protocol ID
- acute subdural hematoma
- Status last verified
- Jun 2019
- First submitted
- 30 May 2019
- Last updated
- 18 Jun 2019
- Results posted
- 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 18 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Traumatic Acute Subdural Haematoma: Management and Outcome
- ClinicalTrials.gov ID
- NCT03971240
- Acronym / sponsor ID
- acute subdural hematoma
- Conditions
- Traumatic Brain Hemorrhage
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 39 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Sep 2019 (estimated)
- Primary completion
- 31 Aug 2020 (estimated)
- Study completion
- 31 Jan 2021 (estimated)
- First posted
- 3 Jun 2019 (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.
Traumatic acute subdural haematomas (ASDHs) are common pathological entity in neurosurgical practice . The frequency of (ASDHs) has been proposed as approximately 10-20% of patients admitted with traumatic brain injury(TBI) .Approximately two -thirds of patient with TBI undergoing emergency cranial surgery have an acute subdural haematoma evacuated . Two common causes of traumatic ASDH: accumulation of blood around parenchymal laceration , usually frontal and temporal lobes and there is usually severe underlying brain injury .The second cause is surface or bridging vessel torn from cerebral acceleration - deceleration during violent head motion .
Detailed description
Traumatic acute subdural haematomas (ASDHs) are common pathological entity in neurosurgical practice . The frequency of (ASDHs) has been proposed as approximately 10-20% of patients admitted with traumatic brain injury(TBI) .Approximately two -thirds of patient with TBI undergoing emergency cranial surgery have an acute subdural haematoma evacuated . Two common causes of traumatic ASDH: accumulation of blood around parenchymal laceration , usually frontal and temporal lobes and there is usually severe underlying brain injury .The second cause is surface or bridging vessel torn from cerebral acceleration - deceleration during violent head motion . These haematomas have been historically associated with high mortality rate (between 40-60%)(1).This high mortality rate has been attributed to the characteristic of haematoma itself , due to the primary insults to the brain like brain parenchymal injury , and to the secondary insults like hypoxia and hypotension in severe head injury patients .
Theoretically ,intracranial hypertension due to ASDH may lead to transtentorial cerebral herniation and secondary ischemic injury of the brain.CT scan is main and most informative investigatory aid in diagnosis of traumatic ASDH. The criteria used to select patients for non - operative management are clinical stability or improvement during the time from injury to evaluation at hospital , haematoma thickness less than 10 mm and mid line shift less than 5 mm in the initial CT. Surgery is indicated if on CT 1- ASDH with thickness > 10mm. or 2- Mid line shift >5mm.on CT 3- ASDH with thickness <10 mm and midline shift <5mm on CT should undergo surgical evaluation if (a) GCS drop by >_ 2 point from injury to admission .(b) and or pupils are asymmetric or fixed and dilated (7). Time of surgery for ASDH is matter of controversy. As general principle ,when surgery for ASDH is indicated it should be done as soon as possible . Regarding evacuation of acute subdural haematoma, procedures vary from single burrhole evacuation to craniotomies and decompressive procedures .Some advocated ASDH evacuations by decompressive craniectomy with dural - slits .
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| outcome of surgically evacuated traumatic ASDH | Experimental | Procedure: evacuation of traumatic acute subdural hematomawe will operate patients with traumatic acute subdural hematoma with some criteria and evaluate the outcome of surgery |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- patients with traumatic ASDH with thickness greater than 10 mm on CTscan
- patients with traumatic ASDH associated with mid -line shift more than 5 mm on CT scan.
Key exclusion criteria (2 listed)
- patients with blood diseases or defective coagulation.
- CT demonstrates associated other intracranial hematomas e.g. epidural , intracerebral or subarachenoid haemorrhage.
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 |
|---|---|---|
| evacuation of traumatic acute subdural hematomacraniotomy will be done with evacuation of the hematoma | Procedure or surgery | outcome of surgically evacuated traumatic ASDH |
Primary outcome
clinical outcome
Time frame: within 6 weeks post operative
evaluation of the clinical outcome by recording the the patients' outcome by modified rankin scale: G"0'' No disability at all. (+1) No significant disability despite symptoms, able to carry out all usual duties and activities. (+2) Slight disability ,unable to carry out all previous activities, but able to look after own affairs without assistance. (+3) Moderate disability, requiring some help, but able to walk without assistance. (+4) Moderately severe disability, unable to walk and attend to bodily needs without assistance. (+5) Severe disability, bedridden, incontinent and requiring constant nursing care attention. (+6) Dead
radiological outcome
Time frame: one day post operative and within 6 weeks post operative
radiological outcome assessment by CT brain scan by measuring the midline shift in millimeters ( mild midline shift if < 5mm , moderate if = 5 mm. and severe midline shift if > 5mm. )
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2019.
- 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.
mohamed alghriany principal investigator
Assiut University
Questions about this trial
What is this clinical trial studying?
A study testing evacuation of traumatic acute subdural hematoma in people with Traumatic Brain Hemorrhage, run by Assiut University.
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 2 inclusion and 2 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 18 Jun 2019. 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 mohamed alghriany (+2001008155135, vetchalg@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
clinical outcome (time frame: within 6 weeks post operative). 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?
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 18 Jun 2019.