The Role of Neurofilament Light (NfL) in Patients With Hydrocephalus

NACompletedINTERVENTIONAL
Enrollment

41

Participants

Timeline

Start Date

December 7, 2023

Primary Completion Date

September 27, 2025

Study Completion Date

September 27, 2025

Conditions
HydrocephalusBrain DamageGeneral Anesthetics Toxicity
Interventions
DIAGNOSTIC_TEST

Lumbar puncture

Standardized lumbar puncture in L3/4 or L4/5 in diagnosis of hydrocephalus and CSF sampling (sample 1 in NfL level measurement)

DIAGNOSTIC_TEST

External lumbar drainage

External lumbar drainage placement for assessing responsivity of external derivation of CSF. It is test of responsivity to ventriculo-peritoneal shunt placement

DIAGNOSTIC_TEST

Lumbar infusion test

Diagnostic test accompanying the first lumbar puncture made as i diagnostic test of hydrocephalus. Based on infusion of saline by 90 mL per hour with measurement of CSF pressure each 1 minute and then count of so-called Rout (index).

PROCEDURE

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).

PROCEDURE

General Anesthesia

Standardized combinated general anesthesia with combination of i.v. and inhalated drugs according the protocol. Given by anesthesiologist.

PROCEDURE

Prechamber puncture

Puncture of prechamber (place behind the ear under the skin) by thin needle and aspiration of 5 mL of CSF (5 days, 1 month a 2 months after surgery)

PROCEDURE

Blood sampling #1

Blood sampling to get level of NfL from standarized percutaneous vein puncture by thin needle 24 hours prior surgery

PROCEDURE

Blood sampling #2

Blood sampling to get level of NfL from standarized percutaneous vein puncture by thin needle 24 hours after surgery

PROCEDURE

Blood sampling #3

Blood sampling to get level of NfL from standarized percutaneous vein puncture by thin needle 5 days after surgery

PROCEDURE

Blood sampling #4 and #5

Blood sampling to get level of NfL from standarized percutaneous vein puncture by thin needle 1 and 2 months after surgery (only in interventional group)

Trial Locations (1)

50005

University Hospital Hradec Kralove, Hradec Králové

All Listed Sponsors
lead

University Hospital Hradec Kralove

OTHER

NCT05399602 - The Role of Neurofilament Light (NfL) in Patients With Hydrocephalus | Biotech Hunter | Biotech Hunter