NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCTs061190002

Registered date:20/05/2019

Evaluation of Overflow leak test

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedintracranial hypotension
Date of first enrollment01/05/2019
Target sample size18
Countries of recruitment
Study typeInterventional
Intervention(s)20 mL of ARTCEREB Irrigation and Perfusion Solution for Cerebrospinal Surgery will be injected into the subarachnoid space using regular lumbar puncture procedure as an overflow leak test. Injection is done at the ward. MRI imaging is done within one hour after injection. Cerebrospinal fluid which subsequently exceeds the volume of the medullary cavity and overflows will be imaged with MRI fat suppression T2WI and compared with the MRI image taken in advance to identify the leakage site.

Outcome(s)

Primary OutcomeEvaluation of the effectiveness of identifying leakage sites with the overflow leak test through comparison of the overflow leak test and CT myelogram
Secondary Outcome(1) Comparison of MRI image findings taken as routine care before Overflow leak test and MRI image findings at Overflow leak test. (2) Name of adverse event, date of onset, severity (severity), severity, treatment for study subject, outcome and date of outcome, causal relationship with the concerned study.

Key inclusion & exclusion criteria

Age minimum>= 18age old
Age maximumNot applicable
GenderBoth
Include criteria1. Patient with intracranial hypotension(Patient confirmed to have cerebrospinal fluid pressure below 60mmH2O) 2. Patient 18 years old or above 3. Written consent concerning participation in this research has been obtained from the participant (or from the individual legal guardian if incapable of consenting)
Exclude criteria1. Patient with a bleeding tendency 2. Patient for whom a lumbar puncture would be difficult 3. Pregnant woman 4. Patient deemed unfit by a doctor

Related Information

Contact

Public contact
Name Eiichi Nakai
Address Kohasu 185-1, Okocho, Nankoku, Kochi, Japan Kouchi Japan 783-8505
Telephone +81-88-880-2397
E-mail enakai@kochi-u.ac.jp
Affiliation Kochi Medical School Hospital
Scientific contact
Name Eiichi Nakai
Address Kohasu 185-1, Okocho, Nankoku, Kochi, Japan Kouchi Japan 783-8505
Telephone +81-88-880-2397
E-mail enakai@kochi-u.ac.jp
Affiliation Kochi Medical School Hospital