Subarachnoid Hemorrhage, TraumaticOSMO-SAHNCT05858060
Osmotic Therapy for Patients With Severe Subarachnoid Hemorrhage
An observational study of Subarachnoid Hemorrhage, Traumatic, run by Xuanwu Hospital, Beijing at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Subarachnoid Hemorrhage, Traumatic
- How many people
- 124 participants
- Where
- 1 siteChina
- Study dates
- 10 Jul 2023to 31 Jan 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- ①age ≥18； ②aneurysmal subarachnoid hemorrhage; ③Hunt-Hess 3-5级
Who cannot join
- 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);
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Subarachnoid Hemorrhage, Traumatic
- Keywords
- Subarachnoid Hemorrhage, mannitol, hypertonic saline, outcome
- Medical subject headings
- Subarachnoid Hemorrhage, Traumatic, Subarachnoid Hemorrhage
What is being measured
The primary outcome is the main question the study is designed to answer.
modified Rankin score
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.
Measured: 1 month after ictus
modified Rankin score
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2023
- Study start10 Jul 2023
- Primary completion31 Dec 2025
- Study completion31 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Subarachnoid Hemorrhage, TraumaticStudies of the same condition, open and under way.
- More trials run by Xuanwu Hospital, BeijingThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lidan Jiang, Xuanwu Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05858060
- Sponsor's protocol ID
- XWNeurosurgicalICU
- Acronym
- OSMO-SAH
- Status last verified
- Sep 2026
- First submitted
- 4 May 2023
- Last updated
- 17 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40713038
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Practice of Osmotherapy in Severe SubArachnoid Hemorrhage Patients: Multicenter Observational Study (OSMO-SAH Study)
- ClinicalTrials.gov ID
- NCT05858060
- Acronym / sponsor ID
- OSMO-SAH / XWNeurosurgicalICU
- Conditions
- Subarachnoid Hemorrhage, Traumatic
- Keywords
- Subarachnoid Hemorrhage, mannitol, hypertonic saline, outcome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Study start
- 10 Jul 2023 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Jan 2026 (actual)
- First posted
- 15 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- ①age ≥18； ②aneurysmal subarachnoid hemorrhage; ③Hunt-Hess 3-5级
Key exclusion criteria (10 listed)
- previous cranial decompression surgery, cerebrospinal fluid leakage or drainage,
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Derived from this study: PubMed 40713038Jiang 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Subarachnoid Hemorrhage, Traumatic, run by Xuanwu Hospital, Beijing at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
modified Rankin score (time frame: 1 month after ictus). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05858060, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.