Status:
ACTIVE_NOT_RECRUITING
Clinical Pilot Study to Evaluate a New Multi-parameter Neuromonitoring Device in Brain-injured Patients
Lead Sponsor:
Carag AG
Conditions:
Brain Injuries
Eligibility:
All Genders
18-75 years
Phase:
NA
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 monitor...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2027
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT03249220
Start Date
September 1 2020
End Date
September 30 2027
Last Update
November 28 2025
Active Locations (2)
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1
Inselspital Bern
Bern, Canton of Bern, Switzerland, 3010
2
Centre Hospitalier Universitaire Vaudois CHUV
Lausanne, Canton of Vaud, Switzerland, 1011