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

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.

Study Overview

• Status: Completed
• Conditions: Subarachnoid Hemorrhage
• Intervention / Treatment: Device: Transcranial doppler

Detailed 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

• Study Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

• Egypt
  • Mansoura, Egypt
    • Mansoura University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

This study was a prospective study conducted on 45 consecutive aSAH patients Forty patients continued in the study and five patients were excluded because of their clinical deterioration within the first five days of the onset and or the associated decompensated systemic illness. SAH cases divided according to the presence of vasospasm into two groups; the first group included 27 cases without vasospasm, while the second group included 13 cases with vasospasm.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cerebral vasospasm; 13 patients developed symptomatic cerebral vasospasm detected by CT angiography and TCD	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.
Non Vasospasm; 27 patients without cerebral vasospasm	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Mansoura University Hospital

Publications and helpful links

General Publications

• Esmael A, Belal T, Eltoukhy K. Transcranial Doppler for Early Prediction of Cognitive Impairment after Aneurysmal Subarachnoid Hemorrhage and the Associated Clinical Biomarkers. Stroke Res Treat. 2020 Nov 23;2020:8874605. doi: 10.1155/2020/8874605. eCollection 2020.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Actual): January 1, 2019
• Study Completion (Actual): February 1, 2019

Study Registration Dates

• First Submitted: March 30, 2020
• First Submitted That Met QC Criteria: March 30, 2020
• First Posted (Actual): April 1, 2020

Study Record Updates

• Last Update Posted (Actual): April 1, 2020
• Last Update Submitted That Met QC Criteria: March 30, 2020
• Last Verified: March 1, 2020

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; Intracranial Hemorrhages; Hemorrhage; Subarachnoid Hemorrhage; Vasospasm, Intracranial
• Other Study ID Numbers: Mansoura University 14

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