- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06628531
ALI & Pulmonary HA Deposition After SAH
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Xintong Dr. Ge
- Phone Number: 86-13662055012
- Email: xge@tmu.edu.cn
Study Locations
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Tianjin, China, 300052
- Recruiting
- Tianjin Medical University General Hospital
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Contact:
- Yi Wang
- Phone Number: 86-022-60362237
- Email: zyyjgb_ms@163.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Subarachnoid Hemorrhage (SAH)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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
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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
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During the acute phase (1-5 days post-onset) and the chronic phase (10-14 days post-onset) of patients with SAH
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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
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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
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During the acute phase (1-5 days post-onset) and the chronic phase (10-14 days post-onset) of patients with SAH
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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
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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
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During the acute phase (1-5 days post-onset) and the chronic phase (10-14 days post-onset) of patients with SAH
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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
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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
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During the acute phase (1-5 days post-onset) and the chronic phase (10-14 days post-onset) of patients with SAH
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Xintong Ge, Tianjin Medical University General Hospital
- Principal Investigator: Yadan Li, Tianjin Huanhu Hospital
- Principal Investigator: Ye Tian, Tianjin Medical University General Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Vascular Diseases
- Cardiovascular Diseases
- Pathologic Processes
- Respiratory Tract Diseases
- Hemorrhage
- Lung Diseases
- Intracranial Hemorrhages
- Lung Injury
- Pathological Conditions, Signs and Symptoms
- Subarachnoid Hemorrhage
- Acute Lung Injury
Other Study ID Numbers
- IRB2024-YS-425-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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