Clinical trial NCT04193124: Prolonged Vasospasm in Subarachnoid Hemorrhage
Official title: Clinical Implication of Prolonged Vasospasm in Subarachnoid Hemorrhage
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Subarachnoid Hemorrhage
Vasospasm, Intracranial
Keywords: Subarachnoid Hemorrhage
Vasospasm, Intracranial
Transcranial doppler
Lead sponsor: Hospital El Cruce
Sponsor class: OTHER
First posted: 2019-12-10
Enrollment: 109
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with subarachnoid hemorrhage and vasospasm

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

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.

Eligibility criteria: Inclusion Criteria: Subarachnoid hemorrhage -

Exclusion Criteria: Pregnancy

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Primary outcomes:
measure: Clinical implication
timeFrame: 1 month
measure: Gravity of vasospasm by transcranial doppler
timeFrame: 1 month
Secondary outcomes:
measure: Mortality assessment
timeFrame: six monts
Other outcomes:
measure: Neurological recovery
timeFrame: six monts
Locations:
Study officials:
References:
citation: 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.
citation: 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.
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. doi: 10.2176/nmc.39.677.
citation: 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.