Traumatic Acute Subdural Haematoma: Management and Outcome
Primary Purpose
Traumatic Brain Hemorrhage
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
evacuation of traumatic acute subdural hematoma
Sponsored by
About this trial
This is an interventional treatment trial for Traumatic Brain Hemorrhage
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- patients with blood diseases or defective coagulation.
- CT demonstrates associated other intracranial hematomas e.g. epidural , intracerebral or subarachenoid haemorrhage.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
outcome of surgically evacuated traumatic ASDH
Arm Description
we will operate patients with traumatic acute subdural hematoma with some criteria and evaluate the outcome of surgery
Outcomes
Primary Outcome Measures
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
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. )
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03971240
Brief Title
Traumatic Acute Subdural Haematoma: Management and Outcome
Official Title
Traumatic Acute Subdural Haematoma: Management and Outcome
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2019 (Anticipated)
Primary Completion Date
August 31, 2020 (Anticipated)
Study Completion Date
January 31, 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
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 .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Hemorrhage
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
39 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
outcome of surgically evacuated traumatic ASDH
Arm Type
Experimental
Arm Description
we will operate patients with traumatic acute subdural hematoma with some criteria and evaluate the outcome of surgery
Intervention Type
Procedure
Intervention Name(s)
evacuation of traumatic acute subdural hematoma
Intervention Description
craniotomy will be done with evacuation of the hematoma
Primary Outcome Measure Information:
Title
clinical outcome
Description
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
Time Frame
within 6 weeks post operative
Title
radiological outcome
Description
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. )
Time Frame
one day post operative and within 6 weeks post operative
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
patients with blood diseases or defective coagulation.
CT demonstrates associated other intracranial hematomas e.g. epidural , intracerebral or subarachenoid haemorrhage.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
mohamed alghriany
Phone
+2001008155135
Email
vetchalg@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
mohamed alghriany
Organizational Affiliation
Assiut University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Traumatic Acute Subdural Haematoma: Management and Outcome
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