Clinical Pilot Study to Evaluate a New Multi-parameter Ne... | NCT03249220

NCT03249220

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Oversight Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Label	Type	Description	Intervention Names
CBMS	Experimental		Device: Placement of the CBMS Probe

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Placement of the CBMS Probe	Device	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
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

Eligibility Module

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

Facility	Status	City	State	ZIP	Country	Contacts
Inselspital Bern		Bern	Canton of Bern	3010	Switzerland
Centre Hospitalier Universitaire Vaudois CHUV

ID	Term
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D006259	Craniocerebral Trauma