Traumatic Acute Subdural Haematoma: Management and Outcome

NCT03971240 | Unknown

• 1 other identifier: acute subdural hematoma
• Study Type: interventional
• Target: 39
• Locations: 0 countries
• Sites: N/A

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 .

Conditions

Traumatic Brain Hemorrhage

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

outcome of surgically evacuated traumatic ASDH

EXPERIMENTAL

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

Interventions

evacuation of traumatic acute subdural hematoma PROCEDURE

craniotomy will be done with evacuation of the hematoma

outcome of surgically evacuated traumatic ASDH

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• patients with blood diseases or defective coagulation.
• CT demonstrates associated other intracranial hematomas e.g. epidural , intracerebral or subarachenoid haemorrhage.

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Brain Hemorrhage, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Hemorrhage, Traumatic; Intracranial Hemorrhages; Cerebrovascular Disorders; Craniocerebral Trauma; Trauma, Nervous System; Vascular Diseases; Cardiovascular Diseases; Wounds and Injuries

Study Officials

• mohamed alghriany

  Assiut University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

mohamed alghriany

CONTACT

+2001008155135; vetchalg@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 30, 2019
• First Posted: June 3, 2019
• Study Start: September 1, 2019
• Primary Completion: August 31, 2020
• Study Completion: January 31, 2021
• Last Updated: June 18, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share