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NCT Number: NCT05858060

Osmotic Therapy for Patients With Severe Subarachnoid Hemorrhage

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.

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Key information

Conditions

Subarachnoid Hemorrhage, Traumatic Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Cerebrovascular Trauma Craniocerebral Trauma Hemorrhage Intracranial Hemorrhage, Traumatic Intracranial Hemorrhages Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Subarachnoid Hemorrhage Trauma, Nervous System Vascular Diseases Wounds and Injuries

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Xuanwu Hospital

Beijing, Beijing Municipality, 100053, China

Location status: Recruiting

Location contact

Lidan Jiang, Dr.

CONTACT

[email protected]

+8615101597091

Lidan Jiang, Dr.

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Xuanwu Hospital, Beijing

Other

Registry information

Official study title

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

Acronym: OSMO-SAH

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
May 15, 2023
Registry last updated
Mar 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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