Clinical trial NCT04329208: Predictive Value of Mean Flow Velocity by TCD in Early Cerebral Vasospasm in Aneurysmal Subarachnoid Hemorrhage
Official title: Predictive Value of Mean Flow Velocity by TCD in Early Cerebral Vasospasm in Aneurysmal Subarachnoid Hemorrhage
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Subarachnoid Hemorrhage
Lead sponsor: Mansoura University Hospital
Sponsor class: OTHER
First posted: 2020-04-01
Enrollment: 40
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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

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.

Primary outcomes:
measure: Mean Flow Velocity
timeFrame: 10 days
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura University Hospital
Study officials:
affiliation: Assistant Prof of Neurology
name: Esmael M Ahmed, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.