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OpenTrials
Completed

NCT Number: NCT04193124

Prolonged Vasospasm in Subarachnoid Hemorrhage

The prevalence and clinical implications of prolonged cerebral vasospasm in patients with subarachnoid hemorrhage are unknown.

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Key information

Conditions

Subarachnoid Hemorrhage Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Hemorrhage Intracranial Hemorrhages Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases Vasospasm, Intracranial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

The prevalence and clinical importance of prolonged cerebral vasospasm (after day 21 of bleeding) in patients with subarachnoid hemorrhage is unknown.

Objectives: To determine the prevalence and clinical relevance of prolonged vasospasm in patients with subarachnoid hemorrhage secondary to cerebral aneurysm.

A prospective and observational study was conducted. Adult patients with a diagnosis of subarcnoid hemorrhage CT scan or presence of blood in the cerebrospinal fluid were incorporated. Patients with vasospasm were followed daily with transcranial doppler. Those with technical impossibility to perform transcranial and pregnant Doppler were excluded. Day 0 was defined, the day of the last bleeding.

Evaluation: 1) It was considered in patients with prolonged vasospasm: whether or not it was associated with clinical manifestation (deterioration of the sensory or new neurological deficit) and 2) the magnitude of the vasospasm (mild, moderate or severe) was measured by transcranial doppler.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Subarachnoid hemorrhage -

Exclusion criteria

Pregnancy

-

Treatment and study plan

transcranial doppler.

Diagnostic Test

Daily monitoring of transcranial doppler until the disappearance of the intracranial vasosparm

Primary outcomes

  1. Clinical implication

    Time frame: 1 month

    Presence or not of neurological symptoms related to intracranial vasospasm (delayed cerebral ischemia)

  2. Gravity of vasospasm by transcranial doppler

    Time frame: 1 month

    Mild, moderate and severe according to Aaslid scale

Secondary outcomes

  1. Mortality assessment

    Time frame: six monts

    Mortality was assessed at hospital discharge and at six months

Other outcomes

  1. Neurological recovery

    Time frame: six monts

    Neurological recovery at six months according to Glasgow outcome scale

Sponsors and collaborators

Lead sponsor

Hospital El Cruce

Other

Registry information

Official study title

Clinical Implication of Prolonged Vasospasm in Subarachnoid Hemorrhage

Acronym: PVE

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Dec 10, 2019
Registry last updated
Dec 10, 2019

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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