Prolonged Vasospasm in Subarachnoid Hemorrhage

Subarachnoid Hemorrhage Clinical Trial

— PVE  

Official title:

Clinical Implication of Prolonged Vasospasm in Subarachnoid Hemorrhage

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04193124
• Other study ID #: HEC
• Status: Completed
• Start date: April 2015
• Est. completion date: December 2019

Study information

• Verified date: December 2019
• Source: Hospital El Cruce
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 109
• Est. completion date: December 2019
• Est. primary completion date: January 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria: Subarachnoid hemorrhage -

Exclusion Criteria: Pregnancy

-

Related Conditions & MeSH terms

• Hemorrhage
• Subarachnoid Hemorrhage
• Vasospasm, Intracranial

Intervention

Diagnostic Test:
• transcranial doppler.
Daily monitoring of transcranial doppler until the disappearance of the intracranial vasosparm

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hospital El Cruce

References & Publications (4)

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. — View Citation

MASPES PE, MARINI G. Intracranial arterial spasm related to supraclinoid ruptured aneurysms. Acta Neurochir (Wien). 1962 Dec 12;10:630-8. — View Citation

Müller 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Neurological recovery	Neurological recovery at six months according to Glasgow outcome scale	six monts
Primary	Clinical implication	Presence or not of neurological symptoms related to intracranial vasospasm (delayed cerebral ischemia)	1 month
Primary	Gravity of vasospasm by transcranial doppler	Mild, moderate and severe according to Aaslid scale	1 month
Secondary	Mortality assessment	Mortality was assessed at hospital discharge and at six months	six monts