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aICP Measurement in Patients With Cerebral Artery Infarction / aICP MCA Infarction

NCT03641963 · Status: SUSPENDED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2020-02-27

No results posted yet for this study

Summary

Space-occupying, malignant middle cerebral artery (M-MCA) infarctions are still one of the most devastating forms of ischemic stroke, with a mortality of up to 80% in untreated patients. It is reported that early hemicraniectomy leads to a substantial decrease in mortality at 6 and 12 months and is likely to improve functional outcome. Thus, this study investigates if non-invasive intracranial pressure (ICP) measuring could represent an objective value to determine the time point to indicate decompressive craniectomy surgery.

However, there are still important questions about the individual indication for decompressive surgery. In consideration of a variable clinical course (some patients develop fatal brain edema early, whereas other patients do not show severe brain swelling for several days), achieving a way to measure, control and predict malignant brain edema formation would be of extremely important value.

Conditions

  • Stroke, Acute

Interventions

DEVICE

Vittamed 205 Non-invasive intracranial pressure (ICP) meter

Non-Invasive intracranial pressure measurement

Sponsors & Collaborators

  • Kantonsspital Aarau

    lead OTHER

Principal Investigators

  • Javier Fandino · Kantonsspital Aarau

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-01
Primary Completion
2019-09-30
Completion
2021-12-31

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03641963 on ClinicalTrials.gov