Traumatic Acute Subdural Haematoma: Management and Outcome

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 .

Study Overview

• Status: Unknown
• Conditions: Traumatic Brain Hemorrhage
• Intervention / Treatment: Procedure: evacuation of traumatic acute subdural hematoma

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: Interventional
• Enrollment (Anticipated): 39
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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. )	one day post operative and within 6 weeks post operative

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Principal Investigator: mohamed alghriany, Assiut University

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2019
• Primary Completion (Anticipated): August 31, 2020
• Study Completion (Anticipated): January 31, 2021

Study Registration Dates

• First Submitted: May 30, 2019
• First Submitted That Met QC Criteria: May 31, 2019
• First Posted (Actual): June 3, 2019

Study Record Updates

• Last Update Posted (Actual): June 18, 2019
• Last Update Submitted That Met QC Criteria: June 16, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Intracranial Hemorrhage, Traumatic; Hemorrhage; Intracranial Hemorrhages; Hematoma; Hematoma, Subdural; Hematoma, Subdural, Acute; Brain Hemorrhage, Traumatic
• Other Study ID Numbers: acute subdural hematoma

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No