Prolonged Vasospasm in Subarachnoid Hemorrhage

NCT ID: NCT04193124

Last Updated: 2019-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

109 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-04-30

Study Completion Date

2019-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Subarachnoid Hemorrhage Vasospasm, Intracranial

Keywords

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Subarachnoid Hemorrhage Vasospasm, Intracranial Transcranial doppler

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

transcranial doppler.

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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transcranial doppler.

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital El Cruce

OTHER

Sponsor Role lead

Responsible Party

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Nestor Pistillo

Head of Intensive Care Unit at Hospital El Cruce

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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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.

Reference Type RESULT
PMID: 3553456 (View on PubMed)

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.

Reference Type RESULT
PMID: 13933363 (View on PubMed)

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.

Reference Type RESULT
PMID: 10563118 (View on PubMed)

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.

Reference Type RESULT
PMID: 10717509 (View on PubMed)

Other Identifiers

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HEC

Identifier Type: -

Identifier Source: org_study_id