Non-invasive Absolute Intracranial Pressure Measurement in Patients With Malignant Middle Cerebral Artery Infarction for Determination of Timing to Descompressive Craniectomy.
1 other identifier
observational
48
0 countries
N/A
Brief Summary
This is a single centre, observational study with a medical device which has Conformité Européenne (CE) marking. The aim of the study is to demonstrate that patients with malignant middle cerebral artery infarction (M-MCA) show an increased intra-cranial pressure (ICP) compared to neurological patients without M-MCA infarction or other space-occupying indications.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jan 2018
Typical duration for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 17, 2017
CompletedFirst Posted
Study publicly available on registry
July 19, 2017
CompletedStudy Start
First participant enrolled
January 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2020
CompletedJuly 26, 2017
July 1, 2017
2.9 years
July 17, 2017
July 24, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
non-invasive ICP) measurement im mmHg
The primary outcome is the non-invasive, absolute intra-cranial pressure (ICP) in M-MCA patients before decompressive surgery, as determined by the non-invasive ICP absolute value meter in mmHG
3 days
Interventions
Intracranial pressure measurement
Eligibility Criteria
Patient with an ischemic stroke in the internal carotid artery or middle cerebral artery territory at risk of a malignant MCA evolution
You may qualify if:
- Patient with an ischemic stroke in the internal carotid artery or middle cerebral artery territory at risk of a malignant MCA evolution, defined based on clinical presentation, clinical course (showing a progressive deterioration of conscious within the first 24-48 h), and neuroradiological findings.
- Age: ≥ 18 years at admission
- Informed consent obtained
You may not qualify if:
- Patients with wounds, scars including the front orbital region.
- Patients with any known ocular condition that may be worsened by sustained eye pressure.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Kienzler Jennylead
- Swiss National Fund for Scientific Researchcollaborator
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
jenny kienzler
Kantonsspital Aarau
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
July 17, 2017
First Posted
July 19, 2017
Study Start
January 1, 2018
Primary Completion
December 1, 2020
Study Completion
December 1, 2020
Last Updated
July 26, 2017
Record last verified: 2017-07
Data Sharing
- IPD Sharing
- Will not share