32
Participants
Start Date
November 1, 2023
Primary Completion Date
December 31, 2024
Study Completion Date
December 31, 2024
Lumbar puncture
Standardized lumbar puncture in L3/4 or L4/5 in diagnosis of hydrocephalus and cerebrospinal fluid sampling (sample 1 in measurement)
External lumbar drainage
External lumbar drainage placement for assessing responsivity of external derivation of cerebrospinal fluid. It is test of responsivity to ventriculo-peritoneal shunt placement
Ventriculo-peritoneal shunt placement
Surgical procedure based on implantation a thin catheter into brain lateral ventricle (placed through a burrhole from Kocher point) and connection to prechamber and valve (placed behind the ear under skin) and similar thin catheter pushed under skin of neck, chest and abdomen (where put intraperitoneally).
Prechamber puncture
Puncture of prechamber (place behind the ear under the skin) by thin needle and aspiration of 5 mL of cerebrospinal fluid (5 days, 1 month a 2 months after surgery)
Blood sampling #1
Blood sampling to get level of biomarkers (NfL, NfH, NSE, S100, Tau, beta-amyloid) from standardized percutaneous vein puncture by thin needle 24 hours prior surgery
Blood sampling #2
Blood sampling to get level of biomarkers (NfL, NfH, NSE, S100, Tau, beta-amyloid) from standardized percutaneous vein puncture by thin needle 24 hours after surgery
Blood sampling #3
Blood sampling to get level of biomarkers (NfL, NfH, NSE, S100, Tau, beta-amyloid) from standardized percutaneous vein puncture by thin needle 5 days after surgery
Blood sampling #4 and #5
Blood sampling to get level of biomarkers (NfL, NfH, NSE, S100, Tau, beta-amyloid) from standardized percutaneous vein puncture by thin needle 1 and 2 months after surgery (only in interventional group)
University Hospital Hradec Kralove, Hradec Králové
University Hospital Hradec Kralove
OTHER