Clinical Pilot Study to Evaluate a New Multi-parameter Neuromonitoring Device in Brain-injured Pa… (NCT03249220) | Clinical Trial Compass
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Clinical Pilot Study to Evaluate a New Multi-parameter Neuromonitoring Device in Brain-injured Patients
Switzerland1 participantsStarted 2020-09-01
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 ÎĽmol/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 in…
What they're measuring
1
Feasibility: Comparability of regional CBF values and values obtained with CT perfusion and TCD