Clinical trial NCT03249220: Clinical Pilot Study to Evaluate a New Multi-parameter Neuromonitoring Device in Brain-injured Patients
Official title: Clinical Pilot Study to Evaluate a New Multi-parameter Neuromonitoring Device That Allows the Measurement of Regional Cerebral Blood Flow (rCBF), Intracranial Pressure (ICP), Brain Temperature Monitoring and Ventricular Cerebrospinal Fluid (CSF) Drainage in Brain-injured Patients
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Brain Injuries
Lead sponsor: Carag AG
Sponsor class: INDUSTRY
First posted: 2017-08-15
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: Clinical pilot study to evaluate a new multi-parameter neuromonitoring device that allows the measurement of regional cerebral blood flow (rCBF), intracranial pressure (ICP), brain temperature monitoring and ventricular cerebrospinal fluid (CSF) drainage in brain-injured patients.


Eligibility criteria: Inclusion Criteria:

* Adult male or female patient, aged 18 - 75 years
* Brain injured patients with acute intracranial hemorrhage (including aneurysmal subarachnoid hemorrhage (SAH) and spontaneous intracerebral hemorrhage (ICH)) who are admitted to the ICU and have an indication for ICP monitoring and CSF drainage, as per standard patient care
* Informed consent obtained for research in emergency situations according to HRA art. 30 \& 31 at time of inclusion

Exclusion Criteria:

* Known kidney disease, defined as plasma creatinine \> 120 μmol/l
* Known liver disease, defined as AST \> 200 IU/L
* Over-active thyroid or benign tumors of the thyroid
* History of allergic disorders, including allergic reactions, against contrast agents containing iodine, or against ICG
* Patients which have received one of the following medications before being admitted to ICU: Haloperidol, Meperidine, Methadone, Morphine, Phenobarbital and Rifamycin.
* Patients with wounds or scars including the front orbital region.
* Cerebrospinal fluid infection or signs of meningo-encephalitis
* Anemia (hemoglobin \< 10 g/dl) or Thalassemia
* Carbon monoxide poisoning
* Acquired pathological or congenital disorders of the cerebral system, being clinically significant, respectively interfering in the investigator's opinion with the conduct of study
* Documented history of bleeding, clotting or coagulation disorders
* Patients who are not suitable for a CT perfusion
* Subjects who, in the opinion of the investigator, will be inappropriate for inclusion into this clinical investigation or will not comply with requirements of the study
* Any disorder in the investigator's opinion that could interfere with compliance of safety evaluation
* Pre-existing disability and/or legal representative
* Patients who are kept lawfully in an institution
* Participation in another interventional clinical investigation within the last 30 days before start of treatment
* History of, respectively diagnosis of pregnancy, or breastfeeding patients

Primary outcomes:
measure: Feasibility: Comparability of regional CBF values and values obtained with CT perfusion and TCD
timeFrame: Up to 28 days until probe removal
Secondary outcomes:
measure: Safety related to catheter insertion and monitoring
timeFrame: Until 7 days after probe removal
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Centre Hospitalier Universitaire Vaudois CHUV
state: VD
Study officials:
affiliation: Centre Hospitalier Universitaire Vaudoise CHUV
name: Mauro Oddo, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: