UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060109 |
|---|---|
| Receipt number | R000068466 |
| Scientific Title | A randomized controlled trial to investigate the effect of systemic heparinization with or without intravenous heparin administration during flow diverter and Woven EndoBridge Device placement on ischemic and bleeding complications |
| Date of disclosure of the study information | 2025/12/19 |
| Last modified on | 2025/12/18 09:03:12 |
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Basic information
Public title
A randomized controlled trial to investigate the effect of systemic heparinization with or without intravenous heparin administration during flow diverter and Woven EndoBridge Device placement on ischemic and bleeding complications
Acronym
A randomized controlled trial to investigate the effect of systemic heparinization with or without intravenous heparin administration during flow diverter and Woven EndoBridge Device placement on ischemic and bleeding complications
Scientific Title
A randomized controlled trial to investigate the effect of systemic heparinization with or without intravenous heparin administration during flow diverter and Woven EndoBridge Device placement on ischemic and bleeding complications
Scientific Title:Acronym
A randomized controlled trial to investigate the effect of systemic heparinization with or without intravenous heparin administration during flow diverter and Woven EndoBridge Device placement on ischemic and bleeding complications
Region
| Japan |
Condition
Condition
unruptured aneurysm
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this study, we conducted a prospective, double-blind, randomized study to verify the hypothesis that flow diverter placement for unruptured cerebral aneurysms without intraoperative heparinization does not increase the risk of ischemic complications.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
- Presence or absence of ischemic complications
- Presence or absence of bleeding complications
- Puncture site problems
(presence or absence of pseudoaneurysm, recompression of the puncture site, presence or absence of AV shunt, presence or absence of protamine reversal, etc.)
- DWI positive rate and number of lesions (by size) on postoperative head MRI
- mRS at 3 months after surgery
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
A group that undergoes systemic heparinization during flow diverter or W-EB placement for unruptured cerebral aneurysms
Interventions/Control_2
Group without systemic heparinization during flow diverter or W-EB placement for unruptured cerebral aneurysms
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Cerebral aneurysms eligible for Flow diverter placement are wide-neck aneurysms with a maximum diameter of 5mm or more and a neck diameter of 4mm or more, depending on the indications for each flow diverter. They must be unruptured or ruptured for more than 42 days. Aneurysms eligible for W-EB placement are wide-neck (defined as a neck diameter of 4mm or more or a dome/neck ratio of less than 2m) intracranial aneurysms located at the bifurcation of the anterior or posterior circulation. Eligible patients are limited to non-pregnant women aged 20 years or older.
Key exclusion criteria
Patients who are taking anticoagulants due to a history of atrial fibrillation, deep vein thrombosis, or other medical diseases will be excluded.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Fujii |
Organization
Fukuoka Neurosurgical Hospital
Division name
Department of neurosurgery
Zip code
8111313
Address
5-3-15, Osa, Minami-ku, Fukuoka-shi, Fukuoka-ken, Japan
TEL
092-558-0081
takashigreengreen@gmail.com
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Fujii |
Organization
Fukuoka Neurosurgical Hospital
Division name
Department of Neurosurgery
Zip code
8111313
Address
5-3-15, Osa, Minami-ku, Fukuoka-shi, Fukuoka-ken
TEL
092-558-0081
Homepage URL
takashigreengreen@gmail.com
Sponsor or person
Institute
Fukuoka Neurosurgical Hospital
Institute
Department
Personal name
Funding Source
Organization
Fukuoka Neurosurgical Hospital
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fukuoka Neurosurgical Hospital IRB comittee
Address
5-3-15, Osa, Minami-ku, Fukuoka-shi, Fukuoka-ken
Tel
092-558-0081
takashigreengreen@gmail.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Fukuoka
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 12 | Month | 19 | 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
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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 10 | Month | 29 | Day |
Date of IRB
| 2025 | Year | 10 | Month | 29 | Day |
Anticipated trial start date
| 2025 | Year | 10 | Month | 29 | Day |
Last follow-up date
| 2027 | Year | 10 | Month | 29 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 12 | Month | 18 | Day |
Last modified on
| 2025 | Year | 12 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068466
