UMIN-ICDS Clinical Trial

Public title

Monitoring strategies and Outcomes: Systematic Assessment in Intensive Care for SAH

Acronym

MOSAIC-SAH study

Scientific Title

Monitoring strategies and Outcomes: Systematic Assessment in Intensive Care for SAH

Scientific Title:Acronym

MOSAIC-SAH study

Region

Japan

Condition

Aneurysmal subarachnoid hemorrhage

Classification by specialty

Neurosurgery

Intensive care medicine

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To estimate the adjusted exploratory association between prespecified monitoring configuration categories based on patient-specific plans active at the start of Day 4 after aneurysmal subarachnoid hemorrhage and favorable functional outcome (modified Rankin Scale [mRS] 0-2) at 90 days after onset. The day of onset is Day 0. Categories are fixed at the start of Day 4 and are not reclassified according to subsequent monitoring performance, additions, discontinuation, or outcomes. Secondary objectives are to describe the ordinal distribution of 90-day mRS, discharge mRS, symptomatic cerebral vasospasm, and delayed cerebral ischemia (DCI)-related cerebral infarction. Thirteen facility-level monitoring policies are described individually without an unvalidated sum score. This observational study does not establish device-specific efficacy, safety, reduction in complications, or the minimum necessary monitoring intensity.

Basic objectives2

Others

Basic objectives -Others

Exploratory estimation of associations between early monitoring plans and functional outcomes.

Trial characteristics_1

Exploratory

Trial characteristics_2

Others

Developmental phase

Not applicable

Primary outcomes

Proportion of patients with a modified Rankin Scale (mRS) score of 0-2 at 90 days after onset.

Key secondary outcomes

Ordinal distribution of mRS at 90 days after onset; proportion with mRS 0-2 at discharge from the initial acute-care admission; and incidence of symptomatic cerebral vasospasm and DCI-related cerebral infarction during that admission. DCI-related infarction is assessed within 6 weeks after onset and during the initial acute-care admission. Unassessable 90-day mRS is reported as missing; such patients are not replaced by other cases.

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

Age-lower limit

18

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Patients meeting all of the following: (1) subarachnoid hemorrhage caused by a ruptured intracranial aneurysm; (2) definitive treatment by open surgery or an endovascular procedure; (3) postoperative perioperative management for DCI and cerebral vasospasm, regardless of the use or type of prophylactic medication; (4) age 18 years or older; and (5) admission between April 1, 2023 and March 31, 2026.

Key exclusion criteria

Traumatic subarachnoid hemorrhage; nonaneurysmal subarachnoid hemorrhage; death before the start of Day 4 precluding classification of presymptomatic monitoring intensity; or refusal to participate through the opt-out procedure. Patients who meet the registration criteria but are ineligible for the Day 4 landmark analysis or have unverifiable timing remain registered and are not replaced by other cases.

Target sample size

400

Name of lead principal investigator

1st name	Shinsuke
Middle name
Last name	Muraoka

Organization

JCHO Chukyo Hospital

Division name

Department of Neurosurgery

Zip code

457-8510

Address

1-1-10 Sanjo, Minami-ku, Nagoya-shi, Aichi, Japan

TEL

052-691-7151

Email

neuro-smuraoka@umin.ac.jp

Name of contact person

1st name	Shinsuke
Middle name
Last name	Muraoka

Organization

JCHO Chukyo Hospital

Division name

Department of Neurosurgery

Zip code

457-8510

Address

1-1-10 Sanjo, Minami-ku, Nagoya-shi, Aichi, Japan

TEL

052-691-7151

Homepage URL

Email

neuro-smuraoka@umin.ac.jp

Institute

Japan Community Healthcare Organization Chukyo Hospital

Institute

Department

Personal name

Shinsuke Muraoka

Organization

The Japanese Society of Intensive Care Medicine

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Ethics Subcommittee, JCHO Chukyo Hospital

Address

1-1-10 Sanjo, Minami-ku, Nagoya-shi, Aichi, Japan

Tel

052-691-7151

Email

rinrikanri@chukyo.jcho.go.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

JCHO中京病院（愛知県）

Date of disclosure of the study information

2026

Year

11

Month

02

Day

URL releasing protocol

Publication of results

Unpublished

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

There is currently no plan to share individual participant data outside the research team.

IPD sharing Plan description

There is currently no plan to share individual participant data outside the research team. Any future sharing outside the research team would be subject to separate ethics review and completion of all required procedures.

Recruitment status

Preinitiation

Date of protocol fixation

2026

Year

07

Month

24

Day

Date of IRB

Anticipated trial start date

2026

Year

11

Month

02

Day

Last follow-up date

2027

Year

03

Month

31

Day

Date of closure to data entry

2027

Year

03

Month

31

Day

Date trial data considered complete

Date analysis concluded

Other related information

Multicenter retrospective cohort study abstracting existing records for this study, not secondary use of an existing registry. Each site enrolls up to 20 consecutive eligible adult aneurysmal SAH admissions, in reverse chronological order, from April 1, 2023 to March 31, 2026; sites with fewer than 20 include all eligible cases. Eligible cases are not replaced for severity, death on or after Day 4, or missing 90-day mRS. The target is 400 patients at 20 or more sites. Exposure is fixed from patient-specific plans active at the start of Day 4, without reclassification by later performance, additions or discontinuation. Configuration categories 0/1/2 are derived centrally from nine groups and the status of unselected groups. A 17-question facility form, including 13 policy items, is collected once; a 14-question patient form is collected per case. The primary outcome is mRS 0-2 at 90 days after onset. Categories are nominal in a covariate-adjusted logistic mixed model with a site random intercept. Associations do not establish minimum required intensity, preventive efficacy, or safety of low-intensity care. Study-specific abstraction/enrollment is estimated to start November 2, 2026, conditional on ethics and institutional procedures, information disclosure, entry/export verification and secure storage preparation. Final study-specific handling of participants (verification and collection of existing information) is estimated for March 31, 2027. Planned dates will be updated when changed. No new prospective follow-up is added; historical admission dates and patient-level Day 4 and 90-day assessment windows remain unchanged.

Registered date

2026

Year

10

Month

20

Day

Last modified on

2026

Year

10

Month

20

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072508