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Observation of the clinical efficacy of cevelestat sodium for injection in patients with severe acute brain injury ARDS

Observation of the clinical efficacy of cevelestat sodium for injection in patients with severe acute brain injury ARDS

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500101795
Enrollment
Unknown
Registered
2025-04-29
Start date
2025-05-01
Completion date
Unknown
Last updated
2025-05-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with severe acute brain injury and ARDS

Interventions

Intervention group:Cevelestat sodium for injection

Sponsors

Changzhou Wujin People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Age>=18 years and, <=75 years, gender is not limited; 2. Patients who are able to administer within 72 hours of the onset of ARDS; 3. Patients with any type of simple acute brain injury, including: structural brain injury with trauma; Structural brain injury without trauma (i.e., intracerebral hemorrhage, subarachnoid hemorrhage, or acute ischemic stroke); Non-structural brain injury (i.e., cardiac arrest or meningitis, etc.); 4. Confirmed diagnosis of acute respiratory distress syndrome according to the latest global diagnostic criteria for ARDS released by the American Thoracic Society International Conference (ATS 2023) in May 2023; 5. Doctors carry out routine treatment according to the patient's condition; 6. Study participants voluntarily sign the informed consent form;

Exclusion criteria

Exclusion criteria: 1. Age3 weeks) and/or recent (within 5 days prior to screening) use of high-dose corticosteroids or immune support; 13. Combined with chronic respiratory diseases (including but not limited to chronic obstructive pulmonary disease, chronic emphysema, etc.) 14. Patients with coagulation dysfunction and intracranial tumors 15. Those who are judged by the investigator to be unsuitable to participate in this trial.

Design outcomes

Primary

MeasureTime frame
28-day all-cause mortality;

Secondary

MeasureTime frame
Lung function indicators;Markers of inflammation;Neurological indicators;Patient outcomes;Radiographic changes;

Countries

China

Contacts

Public ContactCui Weiyan

Changzhou Wujin People's Hospital

cuiweiyan82@163.com+86 13915099179

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026