ALI & Pulmonary HA Deposition After SAH

NCT06628531 | Recruiting

• 1 other identifier: IRB2024-YS-425-01
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (2)

• 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

  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

  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

  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

  During the acute phase (1-5 days post-onset) and the chronic phase (10-14 days post-onset) of patients with SAH

Study Arms (1)

Subarachnoid Hemorrhage (SAH)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tianjin Medical University: lead

Study Sites (1)

Tianjin Medical University General Hospital

Tianjin, 300052, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

bronchoalveolar lavage fluid and serum

MeSH Terms

Conditions

Subarachnoid Hemorrhage; Acute Lung Injury

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lung Injury; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Xintong Ge

  Tianjin Medical University General Hospital

  STUDY CHAIR

• Yadan Li

  Tianjin Huanhu Hospital

  PRINCIPAL INVESTIGATOR

• Ye Tian

  Tianjin Medical University General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xintong Dr. Ge

CONTACT

86-13662055012; xge@tmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: September 29, 2024
• First Posted: October 8, 2024
• Study Start: December 1, 2024
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR

Locations

CN (1)