NCT04193124

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
109

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2015

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

December 6, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 10, 2019

Completed
Last Updated

December 10, 2019

Status Verified

December 1, 2019

Enrollment Period

3.8 years

First QC Date

December 6, 2019

Last Update Submit

December 6, 2019

Conditions

Keywords

Subarachnoid HemorrhageVasospasm, IntracranialTranscranial doppler

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • Mortality assessment

    six monts

Other Outcomes (1)

  • Neurological recovery

    six monts

Study Arms (1)

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.

Interventions

transcranial doppler.DIAGNOSTIC_TEST

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

Prolonged vasospasm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with subarachnoid hemorrhage and vasospasm

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related 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. 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.

MeSH Terms

Conditions

Subarachnoid HemorrhageVasospasm, Intracranial

Interventions

Ultrasonography, Doppler, Transcranial

Condition Hierarchy (Ancestors)

Intracranial HemorrhagesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

EchoencephalographyNeuroradiographyNeuroimagingDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisRadiographyUltrasonographyUltrasonography, DopplerDiagnostic Techniques, NeurologicalInvestigative Techniques

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Intensive Care Unit at Hospital El Cruce

Study Record Dates

First Submitted

December 6, 2019

First Posted

December 10, 2019

Study Start

April 1, 2015

Primary Completion

January 1, 2019

Study Completion

December 1, 2019

Last Updated

December 10, 2019

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share