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

Carag AG2 sites in 1 country1 target enrollmentSeptember 1, 2020

ConditionsBrain Injuries

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Brain Injuries
Sponsor: Carag AG
Enrollment: 1
Locations: 2
Primary Endpoint: Feasibility: Comparability of regional CBF values and values obtained with CT perfusion and TCD
Status: Active, not recruiting
Last Updated: 5 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 1, 2020

End Date

September 30, 2027

Last Updated

5 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Carag AG

Responsible Party

Sponsor

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

Outcomes

Primary Outcomes

Feasibility: Comparability of regional CBF values and values obtained with CT perfusion and TCD

Time Frame: 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.