UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054366 |
|---|---|
| Receipt number | R000062100 |
| Scientific Title | Usefulness of cerebrospinal fluid presepsin (soluble CD14 subyupe) as a new marker in the diagnosis of neurosurgical postoperative meningitis |
| Date of disclosure of the study information | 2024/05/10 |
| Last modified on | 2024/05/10 16:27:52 |
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Basic information
Public title
Usefulness of cerebrospinal fluid presepsin (soluble CD14 subyupe) as a new marker in the diagnosis of neurosurgical postoperative meningitis
Acronym
CSF presepsin for postoperative meningitis
Scientific Title
Usefulness of cerebrospinal fluid presepsin (soluble CD14 subyupe) as a new marker in the diagnosis of neurosurgical postoperative meningitis
Scientific Title:Acronym
CSF presepsin for postoperative meningitis
Region
| Japan |
Condition
Condition
Cerebral hemorrhage, subarachnoid hemorrhage, brain tumor, neurotrauma, normal pressure hydrocephalus, postoperative neurosurgical disease
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this study, we will measure CSF presepsin and examine the variation of its value in postoperative neurosurgical patients and its usefulness as a diagnostic marker for meningitis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of CSF Preceptin Levels in Postoperative Meningitis and Postoperative Non-Meningitis Groups
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Cases of neurosurgery performed at our hospital
case of normal pressure hydrocephalus with tap test
Key exclusion criteria
Non-surgical cases
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | yutaka |
| Middle name | |
| Last name | fuchinoue |
Organization
Department of Neurosurgery, Faculty of Medicine, Toho University, Tokyo, Japan
Division name
Department of Neurosurgery
Zip code
143-8541
Address
6-11-1 Omori-nishi, Ota-ku, Tokyo
TEL
03-3762-4151
yutaka.fuchinoue@med.toho-u.ac.jp
Public contact
Name of contact person
| 1st name | yutaka |
| Middle name | |
| Last name | fuchinoue |
Organization
Department of Neurosurgery, Faculty of Medicine, Toho University, Tokyo, Japan
Division name
Department of Neurosurgery
Zip code
143-8541
Address
6-11-1 Omori-nishi, Ota-ku, Tokyo
TEL
03-3762-4151
Homepage URL
yutaka.fuchinoue@med.toho-u.ac.jp
Sponsor or person
Institute
Department of Neurosurgery, Faculty of Medicine, Toho University
Institute
Department
Personal name
Fuchinoue Yutaka
Funding Source
Organization
N/a
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
the Ethics Committee of Toho University Omori Medical Center
Address
6-11-1 Omori-nishi, Ota-ku, Tokyo
Tel
03-3762-4151
omori.rinri@ext.toho-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 05 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
253
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 04 | Month | 07 | Day |
Anticipated trial start date
| 2020 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
N/a
Management information
Registered date
| 2024 | Year | 05 | Month | 10 | Day |
Last modified on
| 2024 | Year | 05 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062100
