Traumatic Acute Subdural Haematoma: Management and Outcome

Traumatic Brain Hemorrhage Clinical Trial

Official title:

Traumatic Acute Subdural Haematoma: Management and Outcome

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03971240
• Other study ID #: acute subdural hematoma
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2019
• Est. completion date: January 31, 2021

Study information

• Verified date: June 2019
• Source: Assiut University
• Contact: mohamed alghriany
• Phone: +2001008155135
• Email: vetchalg[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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 .

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 .

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 39
• Est. completion date: January 31, 2021
• Est. primary completion date: August 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Brain Hemorrhage, Traumatic
• Hematoma
• Hemorrhage
• Intracranial Hemorrhages
• Traumatic Brain Hemorrhage

Intervention

Procedure:
• evacuation of traumatic acute subdural hematoma
craniotomy will be done with evacuation of the hematoma

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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