Predictive Value of Mean Flow Velocity by TCD in Early Cerebral Vasospasm in Aneurysmal Subarachnoid Hemorrhage

Subarachnoid Hemorrhage Clinical Trial

Official title:

Predictive Value of Mean Flow Velocity by TCD in Early Cerebral Vasospasm in Aneurysmal Subarachnoid Hemorrhage

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04329208
• Other study ID #: Mansoura University 14
• Status: Completed
• Start date: January 1, 2018
• Est. completion date: February 1, 2019

Study information

• Verified date: March 2020
• Source: Mansoura University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Aim of this work is to evaluate the transcranial doppler in prediction of cerebral vasospasm in aneurysmal subarachnoid hemorrhage and also to evaluate their advantages over clinical scales in predicting CV.

Description:

Cerebral vasospasm is defined as narrowing of a cerebral blood vessel enough to cause reduction in distal blood flow. Seventy percent of aSAH patients develop angiographic vasospasm but only 30% progress to develop evident neurological deficits. Cerebral vasospasm may be asymptomatic with no clinical symptoms and signs but only abnormal investigations, such as vascular stenosis by angiography or high blood flow speed by Doppler ultrasound.

Standard tests used to determine the source of bleeding and diagnose cerebral vasospasm (CV) include neuroimaging studies that administer contrast either intravenously (computed tomography angiography [CTA]) or intra-arterially (digital subtraction angiography [DSA]). Cerebral blood flow measurements using computed tomography (CT) perfusion techniques may detect the degree of cerebral ischemia in a very early stage. Although well-tolerated, these studies cannot be readily performed on the bedside and expose the patient to additional radiation, thus significantly restricting their use in daily cerebral hemodynamics monitoring. Moreover, they involve patient transportation to the CT scanner and utilization of resources such as nurses, technologists, and ancillary personnel.

Early detection of cerebral vasospasm is an important step in the way of the improvement of the outcome and the survival of aSAH patients. Transcranial duplex (TCD) is a non-invasive modality which can assess the cerebral blood vessels diameters and flow velocities that can be a useful maneuver in early detection of vasospasm after aSAH

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 1, 2019
• Est. primary completion date: January 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 65 Years

Eligibility

Inclusion Criteria:

• Adult patients diagnosed with spontaneous aneurysmal SAH diagnosed by non-contrast brain CT scan at the onset and confirmed by CT angiography within 72 hours of onset were included

Exclusion Criteria:

• Patient with previous history of disabling brain injuries causing focal neurological signs (e.g. motor weakness).

• Patients with poor temporal TCD window required for bedside evaluation of CV.

• Patients with decompensated systemic illness like hepatic, renal and cardiac were excluded.

• Patients with deep coma (GCS<6) were excluded.

Related Conditions & MeSH terms

• Hemorrhage
• Subarachnoid Hemorrhage
• Vasospasm, Intracranial

Intervention

Device:
• Transcranial doppler
TCD examination was performed using DWL-EZ-Dop machine Compumedics GmbH, Singen, Germany. TCD utilizes low-frequency pulsed insonation (2 MHz) to measure blood flow velocity within proximal cerebral arteries, obtaining systolic and diastolic peaks and mean flow velocities (MFV). MFV is defined as (systolic + diastolic)/3 + diastolic velocities, according to Alexandrov et al.. Initial TCD examination was done after admission serving as a baseline state for cerebral circulation. Follow-up TCD examinations was done at fixed intervals on the first, third, fifth, seventh and tenth days of the onset of SAH.

Locations

Country	Name	City	State
Egypt	Mansoura University Hospital	Mansoura

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University Hospital

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Flow Velocity	TCD utilizes low-frequency pulsed insonation (2 MHz) to measure blood flow velocity within proximal cerebral arteries, obtaining systolic and diastolic peaks and mean flow velocities (MFV). MFV is defined as (systolic + diastolic)/3 + diastolic velocities.	10 days