Stroke, Acute Clinical Trial
— aICPStrokeOfficial title:
Non-invasive Absolute Intracranial Pressure Measurement in Patients With Malignant Middle Cerebral Artery Infarction for Determination of Timing to Decompressive Craniectomy
Verified date | February 2020 |
Source | Kantonsspital Aarau |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Suspended |
Enrollment | 48 |
Est. completion date | December 31, 2021 |
Est. primary completion date | September 30, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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 of the patient or consent of patient's next of kin (plus consent of an independent physician) Exclusion Criteria: - Patients with wounds, scars including the front orbital region. - Patients with any known ocular condition that may be worsened by sustained eye pressure. |
Country | Name | City | State |
---|---|---|---|
Switzerland | Kantonsspital Aarau AG | Aarau |
Lead Sponsor | Collaborator |
---|---|
Kantonsspital Aarau |
Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Increased intracranial pressure | 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 | 24 months | |
Secondary | Correlation of ICP, neuroimaging and transcranial color Doppler | Correlation between non-invasive measured ICP and clinical and neuroimaging findings and standard transcranial color Doppler | 24 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05378035 -
DOAC in Chinese Patients With Atrial Fibrillation
|
||
Completed |
NCT03679637 -
Tablet-based Aphasia Therapy in the Acute Phase After Stroke
|
N/A | |
Completed |
NCT03574038 -
Transcranial Direct Current Stimulation as a Neuroprotection in Acute Stroke
|
N/A | |
Completed |
NCT03633422 -
Evaluation of Stroke Patient Screening
|
||
Completed |
NCT04088578 -
VNS-supplemented Motor Retraining After Stroke
|
N/A | |
Not yet recruiting |
NCT05534360 -
Tenecteplase Treatment in Ischemic Stroke Registry
|
||
Withdrawn |
NCT04991038 -
Clinical Investigation to Compare Safety and Efficacy of DAISE and Stent Retrievers for Thrombectomy In Acute Ischemic Stroke Patients
|
N/A | |
Withdrawn |
NCT05786170 -
ERILs Und SNILs Unter SOC
|
N/A | |
Not yet recruiting |
NCT04105322 -
Effects of Kinesio Taping on Balance and Functional Performance in Stroke Patients
|
N/A | |
Recruiting |
NCT03132558 -
Contrast Induced Acute Kidney in Patients With Acute Stroke
|
N/A | |
Completed |
NCT02893631 -
Assessment of Hemostasis Disorders in rtPA-treated Patients Requiring Endovascular Treatment for Ischemic Stroke
|
||
Active, not recruiting |
NCT02274727 -
Biomarker Signature of Stroke Aetiology Study: The BIOSIGNAL-Study
|
||
Completed |
NCT02225730 -
Imaging Collaterals in Acute Stroke (iCAS)
|
||
Terminated |
NCT01705353 -
The Role of HMGB-1 in Chronic Stroke
|
N/A | |
Active, not recruiting |
NCT01581502 -
SAMURAI-NVAF Study: Anticoagulant Therapy for Japanese Stroke Patients With Nonvalvular Atrial Fibrillation (NVAF)
|
N/A | |
Completed |
NCT01182818 -
Fabry and Stroke Epidemiological Protocol (FASEP): Risk Factors In Ischemic Stroke Patients With Fabry Disease
|
N/A | |
Completed |
NCT00761982 -
Autologous Bone Marrow Stem Cells in Middle Cerebral Artery Acute Stroke Treatment.
|
Phase 1/Phase 2 | |
Completed |
NCT00535197 -
Autologous Bone Marrow Stem Cells in Ischemic Stroke.
|
Phase 1/Phase 2 | |
Terminated |
NCT00132509 -
FRALYSE Trial: Comparison of the Classical Rt-PA Procedure With a Longer Procedure in Acute Ischemic Stroke
|
Phase 2 | |
Recruiting |
NCT05760326 -
Diagnostic and Prognostic Role of Clot Analysis in Stroke Patients
|