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

NCT ID: NCT04329208

Last Updated: 2020-04-01

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-01-01
• Study Completion Date: 2019-02-01

Brief 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.

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

Conditions

Subarachnoid Hemorrhage

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Cerebral vasospasm

13 patients developed symptomatic cerebral vasospasm detected by CT angiography and TCD

Transcranial doppler

Intervention Type: 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.

Non Vasospasm

27 patients without cerebral vasospasm

Transcranial doppler

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mansoura University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Esmael

Assistant Prof of Neurology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Esmael M Ahmed, MD

Role: PRINCIPAL_INVESTIGATOR

Assistant Prof of Neurology

Locations

Mansoura University Hospital

Al Mansurah, , Egypt

Countries

Egypt

References

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.

Reference Type: DERIVED

PMID: 33299539 (View on PubMed)

Other Identifiers

Mansoura University 14

Identifier Type: -

Identifier Source: org_study_id