cerebral aneurysm, intracranial hemorrhage, cerebral ischemia, brain edema I67.1 I61.1 I63.9
Conditions
Interventions
Group 1: A non-invasive combined Laser-Doppler-flowmeter and tissue-spectrophotometer is used in patients undergoing scheduled intracranial surgery (group 1) to record local cerebral microcirculation
Sponsors
Neurochirurgische Klinik, Universitätsklinikum Erlangen
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: a) All participants of this study have to be either fully competent or provide a legal guardian for medical concerns b) Written informed consent of the participant or his/her legal guardian c) Age of 18 to 85 years, both genders. d) Depending on the study phase, two groups are investigated: Group 1: Patients undergoing a scheduled neurosurgical operation such as resection of a supra- or infratentorial lesion (meningeoma, vestibular schwannoma, pituitary adenoma, arachnoid cyst) Group 2: Patients with life-threatening neurosurgical disease which requires emergency surgery within 72 hours such as intracranial hemorrhage or brain tumors with mass effect.
Exclusion criteria
Exclusion criteria: a) decompensated liver- or renal disease b) acute coronary syndrome c) severe comorbidity (mRS = 3) d) pregnancy e) last participation in a trial <6 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint (at the time of discharge/ max. 14 days after surgery): death or severe disability according to the modified Rankin Scale (mRS score 4, 5 or 6) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Endpoints (after 3, 6 an 12 months): 1. Median time of survival 2. Degree of disability according the the Karnofsky Perormance Scale or the modified Rankin Scale. 3. Overall mortaility 4. Surgery-related complications | — |
Countries
Germany
Contacts
Public ContactBjörn Sommer
Paracelsus-Klinik Osnabrück, Neurochirurgische Abteilung
Outcome results
None listed