Osmotic Therapy for Patients with Severe Subarachnoid Hemorrhage (OSMO-SAH)

February 27, 2025 updated by: Lidan Jiang, Xuanwu Hospital, Beijing

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

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

124

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100053
        • Recruiting
        • Xuanwu Hospital
        • Contact:
        • Contact:
          • Lidan Jiang, Dr.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients who meet inclusion and exclusion criterias will be consecutively included. Treatment will be given according to expert consensus of local center, including neurosurgical and intensive management.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
modified Rankin score
Time Frame: 6 months
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.
6 months
modified Rankin score
Time Frame: 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.
1 month after ictus

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xuanwu Hospital, Beijing

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 10, 2023

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

May 4, 2023

First Submitted That Met QC Criteria

May 12, 2023

First Posted (Actual)

May 15, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 27, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XWNeurosurgicalICU

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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