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

Not Applicable

Suspended

• Conditions: Brain Injuries
• Interventions: Device: Placement of the CBMS Probe

• Registration Number: NCT03249220
• Lead Sponsor: Carag AG

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-08-02
• Study First Submitted QC: 2017-08-14
• Study First Posted: 2017-08-15
• Study Start: 2018-01-18
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-29
• Last Update Posted: 2023-08-30
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CBMS	Placement of the CBMS Probe	-

Primary Outcome Measures

Name	Time	Method
Feasibility: Comparability of regional CBF values and values obtained with CT perfusion and TCD	Up to 28 days until probe removal	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.

Secondary Outcome Measures

Name	Time	Method
Safety related to catheter insertion and monitoring	Until 7 days after probe removal	Safety related to catheter insertion and monitoring: local hematomas, infections, CSF drainage dysfunction in comparison with other standard intra-ventricular devices.

Trial Locations

Locations (1)

Centre Hospitalier Universitaire Vaudois CHUV; 🇨🇭 Lausanne, VD, Switzerland