Clinical Pilot Study to Evaluate a New Multi-parameter Neuromonitoring Device in Brain-injured Patients

Brain Injuries Clinical Trial

— CBMS FIH  

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT03249220
• Other study ID #: 2015.5703
• Status: Suspended
• Phase: N/A
• Start date: January 18, 2018
• Est. completion date: December 2024

Study information

• Verified date: August 2023
• Source: Carag AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 10
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries

Intervention

Device:
• Placement of the CBMS Probe
Patients will be treated according to standard care in place at the investigation site, when intra-ventricular drainage is needed. Patients will receive the new multifunctional device (CBMS Probe) instead of the single function device generally used. Drainage will be performed by routine standards. Temperature, intracranial pressure and cerebral blood flow will be recorded. Treatment decision will be made by the neurointensive care specialist based on standard care.

Locations

Country	Name	City	State
Switzerland	Centre Hospitalier Universitaire Vaudois CHUV	Lausanne	VD

Sponsors (1)

Lead Sponsor	Collaborator
Carag AG

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility: Comparability of regional CBF values and values obtained with CT perfusion and TCD	Regional CBF values calculated with the investigational devices (CBMS) are within ranges described in literature, and dynamic changes of regional CBF are consistent to those values obtained with established methods CT perfusion and TCD.	Up to 28 days until probe removal
Secondary	Safety related to catheter insertion and monitoring	Safety related to catheter insertion and monitoring: local hematomas, infections, CSF drainage dysfunction in comparison with other standard intra-ventricular devices.	Until 7 days after probe removal