Osmotic Therapy for Patients With Severe Subarachnoid Hemorrhage

NCT ID: NCT05858060

Last Updated: 2025-03-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

124 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-07-10

Study Completion Date

2025-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The goal of this prospective multi-center observational study is to learn about the osmotic therapy in severe subarachnoid hemorrhage (SAH). The main question\[s\] it aims to answer are:

• whether the two osmotic therapy, 20% mannitol and 10% hypertonic saline(HTS), under the same osmotic equivalent, has similar influence on the outcome of SAH patients?

Participants will be given proper treatment according to local expert consensus, including the choice of osmotic medicine. Investigators just record and analyse the data, compare mannitol group and HTS group to see if the outcome of latter is not worse than the former.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Subarachnoid Hemorrhage, Traumatic

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* ①age ≥18; ②aneurysmal subarachnoid hemorrhage; ③Hunt-Hess 3-5级

Exclusion Criteria

* previous cranial decompression surgery, cerebrospinal fluid leakage or drainage,

* bilateral pupils fixed or dilated,

* hemodynamic instability,

* hemoglobin \< 8g / L,

* serum osmolality \> 320 mOsm / L,

⑥ combined with severe organ dysfunction (cardiac, pulmonary, hepatic, renal and so on);

⑦ serious electrolyte disorders (serum sodium concentration \<125 mmol / L or \>170 mmol / L), and difficult to correct within limited time;

⑧ serious acid-base balance disorders, and difficult to correct within limited time;

⑨ use of mannitol or HSS within previous six hours;

⑩ being pregnant.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Xuanwu Hospital, Beijing

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Lidan Jiang

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Xuanwu Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Lidan Jiang, Dr.

Role: primary

+8615101597091

References

Explore related publications, articles, or registry entries linked to this study.

Jiang L, Qi M, Xu Y, Qu X, Chen W, Cheng W, Zhao H, Shang F, Fu X, Wang C, Jiang R, Wang N. Hyperosmolar therapy for severe subarachnoid haemorrhage: a protocol for a multicentre prospective observational study (OSMO-SAH study). BMJ Open. 2025 Jul 25;15(7):e099008. doi: 10.1136/bmjopen-2025-099008.

Reference Type DERIVED
PMID: 40713038 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

XWNeurosurgicalICU

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.