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

August 7, 2023 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:
        • Principal Investigator:
          • 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

N/A

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； ②CT confirmed subarachnoid hemorrhage; ③Hunt-Hess 3-5级

Exclusion Criteria:

  • previous decompressive craniectomy, a leakage or a drainage of cerebrospinal fluid, bilateral fixed and dilated pupils, unstable hemodynamic conditions, oliguric renal failure, hemoglobin < 8g/L, serum osmolality> 320 mOsm/L, combined with serious dysfunction of organs such as heart, lung, liver, and kidney; combined with severe electrolyte disturbances (especially serum sodium concentration <125 mmol/L or >170 mmol/L) and blood gas dysfunction, which are difficult to correct in a short time；use of hypertonic treatment within 6h; 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: 1 day of discharge
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 day of discharge
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

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)

March 31, 2024

Study Completion (Estimated)

March 31, 2024

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)

August 14, 2023

Last Update Submitted That Met QC Criteria

August 7, 2023

Last Verified

August 1, 2023

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

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.

Clinical Trials on Subarachnoid Hemorrhage, Traumatic

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in France

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe