Status:
COMPLETED
A New Multi-parameter Neuromonitoring System to Save Patients' Lives in Stroke and Brain Injury
Lead Sponsor:
NeMoDevices AG
Collaborating Sponsors:
Medical University of Graz
University of Zurich
Conditions:
Subarachnoid Hemorrhage
Optical Imaging
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
To assess the feasibility of a new neuromonitoring system (NeMoSystem including NeMo Probe and NeMo Patch) and the accuracy of the measurement values (cerebral blood flow (CBF); cerebral blood volume ...
Eligibility Criteria
Inclusion
- Adult male or female patient, ≥ 18 and ≤ 75 years
- Patient with severe SAH (GCS ≤ 12) or severe TBI (GCS ≤ 8)
- Decreased level of consciousness with the need for ICP monitoring for an estimated duration of more than 3 days
- Negative pre-treatment serum pregnancy test for female patients with childbearing potential
- In patients with severe SAH or severe TBI with need for ICP monitoring an acute emergency situation exists. The inclusion follows
Exclusion
- Known kidney disease, defined as plasma creatinine \> 120 µmol/l
- Known liver disease, defined as GOT \> 200U/l
- History of allergic disorders, including allergic reactions against contrast agents containing iodine, against ICG and against plasters, as well as patients with thyroid disease causing hyperthyroidism
- Pre-existing disability and/or legal representative
- Participation in another interventional clinical trial within the last 30 days before start of treatment
Key Trial Info
Start Date :
January 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2017
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT01802762
Start Date
January 1 2013
End Date
May 1 2017
Last Update
September 6 2017
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Dept. of Neurosurgery, Medical University of Graz
Graz, Austria, 8036
2
Neurointensive Care Unit, University Hospital Zurich
Zurich, Switzerland, 8091