search
Back to results

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
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Traumatic Brain Hemorrhage

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    May 30, 2019
    Last Updated
    June 16, 2019
    Sponsor
    Assiut University
    search

    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

    We'll reach out to this number within 24 hrs