Evaluation of Overflow leak test

JRCT ID: jRCTs061190002

Registered date:20/05/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: intracranial hypotension
• Date of first enrollment: 01/05/2019
• Target sample size: 18
• Study type: Interventional
• 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 Outcome: Evaluation 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 maximum: Not applicable
• Gender: Both

Include criteria

1. 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 criteria

1. 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

• Primary Sponsor: Nakai Eiichi