Prolonged Vasospasm in Subarachnoid Hemorrhage (PVE)

Clinical Implication of Prolonged Vasospasm in Subarachnoid Hemorrhage

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

Study Overview

• Status: Completed
• Conditions: Subarachnoid Hemorrhage; Vasospasm, Intracranial
• Intervention / Treatment: Diagnostic test: transcranial doppler.

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 109

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with subarachnoid hemorrhage and vasospasm

Description

Inclusion Criteria: Subarachnoid hemorrhage -

Exclusion Criteria: Pregnancy

-

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Prolonged vasospasm; 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. Prolonged vasospasm was defined for patients who persisted with vasospasm after day 21 of cerebral bleeding.	Diagnostic test: transcranial doppler.; Daily monitoring of transcranial doppler until the disappearance of the intracranial vasosparm

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical implication	Presence or not of neurological symptoms related to intracranial vasospasm (delayed cerebral ischemia)	1 month
Gravity of vasospasm by transcranial doppler	Mild, moderate and severe according to Aaslid scale	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality assessment	Mortality was assessed at hospital discharge and at six months	six monts

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neurological recovery	Neurological recovery at six months according to Glasgow outcome scale	six monts

Collaborators and Investigators

• Sponsor: Hospital El Cruce

Publications and helpful links

General Publications

• Harders AG, Gilsbach JM. Time course of blood velocity changes related to vasospasm in the circle of Willis measured by transcranial Doppler ultrasound. J Neurosurg. 1987 May;66(5):718-28. doi: 10.3171/jns.1987.66.5.0718.
• MASPES PE, MARINI G. Intracranial arterial spasm related to supraclinoid ruptured aneurysms. Acta Neurochir (Wien). 1962 Dec 12;10:630-8. doi: 10.1007/BF01406192. No abstract available.
• Yamaguchi M, Bun T, Kuwahara T, Kitamura S. Very late-onset symptomatic cerebral vasospasm caused by a large residual aneurysmal subarachnoid hematoma--case report. Neurol Med Chir (Tokyo). 1999 Sep;39(9):677-80. doi: 10.2176/nmc.39.677.
• Muller M, Schwerdtfeger K, Zieroth S. Assessment of middle cerebral artery diameter after aneurysmal subarachnoid hemorrhage by transcranial color-coded duplex sonography. Eur J Ultrasound. 2000 Mar;11(1):15-9. doi: 10.1016/s0929-8266(99)00066-x.

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 1, 2015
• Primary Completion (ACTUAL): January 1, 2019
• Study Completion (ACTUAL): December 1, 2019

Study Registration Dates

• First Submitted: December 6, 2019
• First Submitted That Met QC Criteria: December 6, 2019
• First Posted (ACTUAL): December 10, 2019

Study Record Updates

• Last Update Posted (ACTUAL): December 10, 2019
• Last Update Submitted That Met QC Criteria: December 6, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: Subarachnoid Hemorrhage; Transcranial doppler; Vasospasm, Intracranial
• 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: HEC

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