UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051906 |
|---|---|
| Receipt number | R000058869 |
| Scientific Title | Establishment of novel hemodynamic managenent to minimize extracranial complications in patients after aneurysmal subarachnoid hemorrhage |
| Date of disclosure of the study information | 2023/08/15 |
| Last modified on | 2023/08/14 19:36:30 |
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Basic information
Public title
Establishment of valid hemodynamic managenent to minimize extracranial complications in patients after aneurysmal subarachnoid hemorrhage
Acronym
Establishment of fluid managenent to minimize systemic complication in patients after SAH
Scientific Title
Establishment of novel hemodynamic managenent to minimize extracranial complications in patients after aneurysmal subarachnoid hemorrhage
Scientific Title:Acronym
Establishment of fluid managenent to minimize systemic complication in patients after SAHAH
Region
| Japan |
Condition
Condition
Aneurysmal subarachnoid hemorrhage
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this trial is to evaluate the efficacy and safety of postoperative fluid therapy against extracranial complication and cerebral vasospasm in patients after subarachnoid hemorrhage.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Overall endpoint: functional outcome assessed by modified Rankin Scale score (0-2: good outcome).
fresh cerebral infarction on day 14 based on MRI diffusion-weighted images.
Safety endpoint: discontinuation or interruption of drug treatment.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
All SAH patients treated aneurysm either by surgical clipping or endovascular coiling.
Key exclusion criteria
None.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Tatsushi |
| Middle name | |
| Last name | Mutoh |
Organization
Research Institute for Brain and Blood Vessels, Akita Cerebrospinal and Cardiovascular Center, Akita, Japan
Division name
Department of Surgical Neurology
Zip code
010-0874
Address
6-10 Senshu-Kubota-machi, Akita 010-0874, Japan
TEL
018-833-0115
tmutoh@akita-noken.jp
Public contact
Name of contact person
| 1st name | Tatsushi |
| Middle name | |
| Last name | Mutoh |
Organization
Research Institute for Brain and Blood Vessels, Akita Cerebrospinal and Cardiovascular Center, Akita
Division name
Department of Surgical Neurology
Zip code
010-0874
Address
6-10 Senshu-Kubota-machi, Akita 010-0874, Japan
TEL
018-833-0115
Homepage URL
tmutoh@akita-noken.jp
Sponsor or person
Institute
Research Institute for Brain and Blood Vessels, Akita Cerebrospinal and Cardiovascular Center, Akita
Institute
Department
Personal name
Funding Source
Organization
Research Institute for Brain and Blood Vessels, Akita Cerebrospinal and Cardiovascular Center, Akita
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Institute for Brain and Blood Vessels, Akita Cerebrospinal and Cardiovascular Center, Akita
Address
6-10 Senshu-Kubota-machi, Akita 010-0874, Japan
Tel
018-833-0115
tmutoh@akita-noken.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
| 2023 | Year | 08 | Month | 15 | 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
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 04 | Month | 01 | Day |
Anticipated trial start date
| 2022 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Body weight, urine volume and fluid balance were measured daily. Ninety-day functional outcomes were determined based on modified Rankin Scale (mRS) scores.
Management information
Registered date
| 2023 | Year | 08 | Month | 14 | Day |
Last modified on
| 2023 | Year | 08 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058869
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
