Subarachnoid Haemorrhage (SAH)NCT06628531
ALI & Pulmonary HA Deposition After SAH
An observational study of Subarachnoid Haemorrhage (SAH), run by Tianjin Medical University at 1 site in China.
Trial summary
Acute lung injury is a common complication of subarachnoid hematoma (SAH), and a significant risk factor for death in patients with SAH. Unlike neurogenic pulmonary edema and pneumonia following brain injury, the clinical causes of pulmonary injury after SAH are not intracranial hypertension or pulmonary infection. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Subarachnoid Haemorrhage (SAH)
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2024to 30 Sep 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Estimated by statistical analysis, a total of 24 subjects were included from patients admitted to the neurosurgical intensive care unit of Tianjin Medical University General Hospital and the intensive care unit of Tianjin Huanhu Hospital due to aneurysmal SAH.
Who may be able to join
- Age between 18 and 80 years old with independent behavior ability or authorized legal representative.
- A documented diagnosis of SAH within 5 days.
- A Hunt-Hess scale of Ⅳ or Ⅴ.
- Absence of clinical and etiological evidence of pulmonary infection.
Who cannot join
- Pregnant or lactating women.
- Present history of traumatic brain injury or intracranial hemorrhage.
- Past history of neurological disorders, lung infection within the past six months, cancer, chronic cardiopulmonary diseases, hematological diseases or renal failure.
- Have participated in clinical trials in the past 4 weeks.
- The investigator considers that not appropriate for inclusion.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Tianjin Medical University General Hospital
Tianjin, 300052
Yi Wang, 86-022-60362237, zyyjgb_ms@163.com
About this study
Official title: Relationship Between Acute Lung Injury and Pulmonary Hyaluronic Acid Deposition After Subarachnoid Hemorrhage
Acute lung injury is a common complication of subarachnoid hematoma (SAH), and a significant risk factor for death in patients with SAH. Unlike neurogenic pulmonary edema and pneumonia following brain injury, the clinical causes of pulmonary injury after SAH are not intracranial hypertension or pulmonary infection. Its occurrence is influenced by the release of catecholamines, the regulatory function of the hypothalamic-pituitary-adrenal (HPA) axis and systemic inflammatory response, but the specific mechanisms are still unclear. Therefore, delving into the pathological mechanisms of SAH-induced lung injury and developing therapeutic strategies based on the findings is of great importance to improve the prognosis of patients.
Abnormal accumulation of hyaluronic acid in the lungs has been reported to be closely related to the pathological progression of various pulmonary injury diseases, such as chest trauma, pulmonary infection and chronic obstructive pulmonary disease. From this, the present research is aimed to explore the levels and dynamic changes of hyaluronic acid in the bronchoalveolar lavage fluid and blood of patients with acute lung injury following SAH, and to analyze its correlation with the prognosis of pulmonary complications, thereby providing assistance for the clinical diagnosis and treatment of SAH.
- Conditions
- Subarachnoid Haemorrhage (SAH)
- Keywords
- Subarachnoid haemorrhage, SAH, acute lung injury, ALI, hyaluronic acid
- Medical subject headings
- Subarachnoid Hemorrhage, Acute Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Subarachnoid Hemorrhage (SAH) | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hyaluronic acid level in bronchoalveolar lavage fluid after SAH
Hyaluronic acid level (ng/ml) in bronchoalveolar lavage fluid at the acute phase (1-5 days post-onset) and the chronic phase (10-14 days post-onset) of patients with SAH
Measured: During the acute phase (1-5 days post-onset) and the chronic phase (10-14 days post-onset) of patients with SAH
Inflammatory cytokines levels in bronchoalveolar lavage fluid after SAH
Inflammatory cytokines (IL-1β, TNF-α and IL-10) levels (pg/ml) in bronchoalveolar lavage fluid at the acute phase (1-5 days post-onset) and the chronic phase (10-14 days post-onset) of patients with SAH
Measured: During the acute phase (1-5 days post-onset) and the chronic phase (10-14 days post-onset) of patients with SAH
Secondary outcomes (2)
Serum hyaluronic acid level after SAH
Serum hyaluronic acid level (ng/ml) at the acute phase (1-5 days post-onset) and the chronic phase (10-14 days post-onset) of patients with SAH
Measured: During the acute phase (1-5 days post-onset) and the chronic phase (10-14 days post-onset) of patients with SAH
Serum inflammatory cytokines levels after SAH
Serum inflammatory cytokines (IL-1β, TNF-α and IL-10) levels (pg/ml) at the acute phase (1-5 days post-onset) and the chronic phase (10-14 days post-onset) of patients with SAH
Measured: During the acute phase (1-5 days post-onset) and the chronic phase (10-14 days post-onset) of patients with SAH
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2024
- Study start1 Dec 2024
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subarachnoid Haemorrhage (SAH)Studies of the same condition, open and under way.
- 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
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xintong Ge, Tianjin Medical University General Hospital
- Investigators
- Xintong Ge, Study chair, Tianjin Medical University General HospitalYadan Li, Principal investigator, Tianjin Huanhu HospitalYe Tian, Principal investigator, Tianjin Medical University General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06628531
- Sponsor's protocol ID
- IRB2024-YS-425-01
- Status last verified
- Mar 2026
- First submitted
- 29 Sep 2024
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Acute Lung Injury and Pulmonary Hyaluronic Acid Deposition After Subarachnoid Hemorrhage
- ClinicalTrials.gov ID
- NCT06628531
- Acronym / sponsor ID
- IRB2024-YS-425-01
- Conditions
- Subarachnoid Haemorrhage (SAH)
- Keywords
- Subarachnoid haemorrhage, SAH, acute lung injury, ALI, hyaluronic acid
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Tianjin Medical UniversityUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 8 Oct 2024 (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.
Acute lung injury is a common complication of subarachnoid hematoma (SAH), and a significant risk factor for death in patients with SAH. Unlike neurogenic pulmonary edema and pneumonia following brain injury, the clinical causes of pulmonary injury after SAH are not intracranial hypertension or pulmonary infection. Its occurrence is influenced by the release of catecholamines, the regulatory function of the hypothalamic-pituitary-adrenal (HPA) axis and systemic inflammatory response, but the specific mechanisms are still unclear. Therefore, delving into the pathological mechanisms of SAH-induced lung injury and developing therapeutic strategies based on the findings is of great importance to improve the prognosis of patients.
Abnormal accumulation of hyaluronic acid in the lungs has been reported to be closely related to the pathological progression of various pulmonary injury diseases, such as chest trauma, pulmonary infection and chronic obstructive pulmonary disease. From this, the present research is aimed to explore the levels and dynamic changes of hyaluronic acid in the bronchoalveolar lavage fluid and blood of patients with acute lung injury following SAH, and to analyze its correlation with the prognosis of pulmonary complications, thereby providing assistance for the clinical diagnosis and treatment of SAH.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subarachnoid Hemorrhage (SAH) | – | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Estimated by statistical analysis, a total of 24 subjects were included from patients admitted to the neurosurgical intensive care unit of Tianjin Medical University General Hospital and the intensive care unit of Tianjin Huanhu Hospital due to aneurysmal SAH.
Key inclusion criteria (4 listed)
- Age between 18 and 80 years old with independent behavior ability or authorized legal representative.
- A documented diagnosis of SAH within 5 days.
- A Hunt-Hess scale of Ⅳ or Ⅴ.
- Absence of clinical and etiological evidence of pulmonary infection.
Key exclusion criteria (5 listed)
- Pregnant or lactating women.
- Present history of traumatic brain injury or intracranial hemorrhage.
- Past history of neurological disorders, lung infection within the past six months, cancer, chronic cardiopulmonary diseases, hematological diseases or renal failure.
- Have participated in clinical trials in the past 4 weeks.
- The investigator considers that not appropriate for inclusion.
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
Hyaluronic acid level in bronchoalveolar lavage fluid after SAH
Time frame: During the acute phase (1-5 days post-onset) and the chronic phase (10-14 days post-onset) of patients with SAH
Hyaluronic acid level (ng/ml) in bronchoalveolar lavage fluid at the acute phase (1-5 days post-onset) and the chronic phase (10-14 days post-onset) of patients with SAH
Inflammatory cytokines levels in bronchoalveolar lavage fluid after SAH
Time frame: During the acute phase (1-5 days post-onset) and the chronic phase (10-14 days post-onset) of patients with SAH
Inflammatory cytokines (IL-1β, TNF-α and IL-10) levels (pg/ml) in bronchoalveolar lavage fluid at the acute phase (1-5 days post-onset) and the chronic phase (10-14 days post-onset) of patients with SAH
2 secondary outcomes
Serum hyaluronic acid level after SAH
Time frame: During the acute phase (1-5 days post-onset) and the chronic phase (10-14 days post-onset) of patients with SAH
Serum inflammatory cytokines levels after SAH
Time frame: During the acute phase (1-5 days post-onset) and the chronic phase (10-14 days post-onset) of patients with SAH
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
- Individual participant dataSharing planned: Yes
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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.
Xintong Ge study chair
Tianjin Medical University General Hospital
Yadan Li principal investigator
Tianjin Huanhu Hospital
Ye Tian principal investigator
Tianjin Medical University General Hospital
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 Haemorrhage (SAH), run by Tianjin Medical University 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 4 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 18 Mar 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xintong Dr. Ge (86-13662055012, xge@tmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hyaluronic acid level in bronchoalveolar lavage fluid after SAH (time frame: During the acute phase (1-5 days post-onset) and the chronic phase (10-14 days post-onset) of patients with SAH). 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?
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 18 Mar 2026.