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

Primary Purpose

Brain Injuries

Status
Suspended
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Placement of the CBMS Probe
Sponsored by
Carag AG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Brain Injuries

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre Hospitalier Universitaire Vaudois CHUV

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CBMS

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
August 2, 2017
Last Updated
August 29, 2023
Sponsor
Carag AG
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1. Study Identification

Unique Protocol Identification Number
NCT03249220
Brief Title
Clinical Pilot Study to Evaluate a New Multi-parameter Neuromonitoring Device in Brain-injured Patients
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Suspended
Why Stopped
Administrative reasons
Study Start Date
January 18, 2018 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Carag AG

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Injuries

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CBMS
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Placement of the CBMS Probe
Intervention Description
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.
Primary Outcome Measure Information:
Title
Feasibility: Comparability of regional CBF values and values obtained with CT perfusion and TCD
Description
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.
Time Frame
Up to 28 days until probe removal
Secondary Outcome Measure Information:
Title
Safety related to catheter insertion and monitoring
Description
Safety related to catheter insertion and monitoring: local hematomas, infections, CSF drainage dysfunction in comparison with other standard intra-ventricular devices.
Time Frame
Until 7 days after probe removal

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mauro Oddo, Prof. Dr.
Organizational Affiliation
Centre Hospitalier Universitaire Vaudoise CHUV
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier Universitaire Vaudois CHUV
City
Lausanne
State/Province
VD
ZIP/Postal Code
1011
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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