Clinical Trial Details
Braintumor Website

[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT01802762 : A New Multi-parameter Neuromonitoring System to Save Patients' Lives in Stroke and Brain Injury
PhaseN/A
AgesMin: 18 Years Max: 75 Years
Eligibility
Inclusion Criteria:

1. Adult male or female patient, ? 18 and ? 75 years

2. Patient with severe SAH (GCS ? 12) or severe TBI (GCS ? 8)

3. Decreased level of consciousness with the need for ICP monitoring for an estimated
duration of more than 3 days

4. Negative pre-treatment serum pregnancy test for female patients with childbearing
potential

5. In patients with severe SAH or severe TBI with need for ICP monitoring an acute
emergency situation exists. The inclusion follows

Exclusion Criteria:

1. Known kidney disease, defined as plasma creatinine > 120 µmol/l

2. Known liver disease, defined as GOT > 200U/l

3. History of allergic disorders, including allergic reactions against contrast agents
containing iodine, against ICG and against plasters, as well as patients with thyroid
disease causing hyperthyroidism

4. Pre-existing disability and/or legal representative

5. Participation in another interventional clinical trial within the last 30 days before
start of treatment
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT01802762      |      Link to official Clinicaltrials.gov listing
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