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OpenTrials
Completed

NCT Number: NCT04329208

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.

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Key information

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Transcranial Doppler

Device

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.

Primary outcomes

  1. Mean Flow Velocity

    Time frame: 10 days

    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.

Sponsors and collaborators

Lead sponsor

Mansoura University Hospital

Other

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Apr 1, 2020
Registry last updated
Apr 1, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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