Osmotic Therapy for Patients With Severe Subarachnoid Hemorrhage

Practice of Osmotherapy in Severe SubArachnoid Hemorrhage Patients: Multicenter Observational Study (OSMO-SAH Study)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05858060

Acronym

OSMO-SAH

Enrollment

124

Registered

2023-05-15

Start date

2023-07-10

Completion date

2026-01-31

Last updated

2026-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Subarachnoid Hemorrhage, Traumatic

Keywords

Subarachnoid Hemorrhage, mannitol, hypertonic saline, outcome

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
modified Rankin score	1 month after ictus	The Modified Rankin Score (mRS) is the most widely used outcome measure for brain injured patients, which ranges from 0-6. Score of 6 means that patient is dead.

Countries

China

Outcome results