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出境医 / 临床实验 / Traumatic Acute Subdural Haematoma: Management and Outcome

Traumatic Acute Subdural Haematoma: Management and Outcome

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 .

Condition or disease Intervention/treatment Phase
Traumatic Brain Hemorrhage Procedure: evacuation of traumatic acute subdural hematoma Not Applicable

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
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 39 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Traumatic Acute Subdural Haematoma: Management and Outcome
Estimated Study Start Date : September 1, 2019
Estimated Primary Completion Date : August 31, 2020
Estimated Study Completion Date : January 31, 2021
Arms and Interventions
Arm Intervention/treatment
Experimental: outcome of surgically evacuated traumatic ASDH
we will operate patients with traumatic acute subdural hematoma with some criteria and evaluate the outcome of surgery
 Procedure: evacuation of traumatic acute subdural hematoma
craniotomy will be done with evacuation of the hematoma
Outcome Measures
Primary Outcome Measures :
  1. 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


  2. 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. )


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations

Contacts
Layout table for location contacts
Contact: mohamed alghriany +2001008155135 vetchalg@gmail.com

Sponsors and Collaborators
Assiut University
Investigators
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Principal Investigator: mohamed alghriany Assiut University
Tracking Information
First Submitted Date  ICMJE May 30, 2019
First Posted Date  ICMJE June 3, 2019
Last Update Posted Date June 18, 2019
Estimated Study Start Date  ICMJE September 1, 2019
Estimated Primary Completion Date August 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 16, 2019)
  • 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. )
Original Primary Outcome Measures  ICMJE
 (submitted: May 31, 2019)
  • 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 and the residual hematoma if found
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Traumatic Acute Subdural Haematoma: Management and Outcome
Official Title  ICMJE Traumatic Acute Subdural Haematoma: Management and Outcome
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 .
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Traumatic Brain Hemorrhage
Intervention  ICMJE Procedure: evacuation of traumatic acute subdural hematoma
craniotomy will be done with evacuation of the hematoma
Study Arms  ICMJE Experimental: outcome of surgically evacuated traumatic ASDH
we will operate patients with traumatic acute subdural hematoma with some criteria and evaluate the outcome of surgery
Intervention: Procedure: evacuation of traumatic acute subdural hematoma
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: May 31, 2019) 		39
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 31, 2021
Estimated Primary Completion Date August 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03971240
Other Study ID Numbers  ICMJE acute subdural hematoma
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Mohamed Ahmed Ibrahim Alghriany, Assiut University
Study Sponsor  ICMJE Assiut University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: mohamed alghriany Assiut University
PRS Account Assiut University
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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