Using Baricitinib to Treat Lung Injury After Brain Bleeding
Efficacy and Safety of Baricitinib in the Post-intracerebral Hemorrhage Pulmonary Injury
This study is testing if the drug baricitinib can help people with lung injury after bleeding in the brain recover better and improve their breathing.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Tianjin Medical University General Hospital Academic / other |
| Drugs / interventions | Baricitinib |
| Locations | 1 site (Tianjin, Tianjin Municipality) |
| Trial ID | NCT06548802 on ClinicalTrials.gov |
What this trial studies
This study evaluates the efficacy and safety of baricitinib in patients who develop pulmonary injury following non-traumatic intracerebral hemorrhage. Baricitinib, previously approved for severe pneumonia related to COVID-19, is being tested for its ability to reduce lung injury caused by excessive inflammation. The study focuses on patients who exhibit acute respiratory distress syndrome (ARDS) within a specific timeframe after their brain hemorrhage. Participants will receive baricitinib to assess its impact on lung function and overall recovery.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with confirmed non-traumatic intracerebral hemorrhage who develop ARDS within 48 hours to 7 days post-admission.
Not a fit: Patients with unresolved pneumonia, interstitial lung disease, or chronic lung conditions may not benefit from this treatment.
Why it matters
Potential benefit: If successful, this treatment could significantly improve recovery outcomes for patients suffering from lung injury after intracerebral hemorrhage.
How similar studies have performed: Previous studies have shown baricitinib's effectiveness in treating severe pneumonia, suggesting potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Male or female patients ≥ 18 years old; 2. The diagnosis was non-traumatic intracerebral hemorrhage, subarachnoid hemorrhage (including supratentorial deep hemorrhage, lobal hemorrhage, cerebellar hemorrhage, brainstem hemorrhage, intracerebral hemorrhage, intracerebral parenchymal hemorrhage into ventricle, subarachnoid hemorrhage), which was confirmed by CT scan. 3. Onset of ARDS within 48 hours to 7 days after admission (as defined by Berlin) : ① Patients with moderate to severe ARDS symptoms or progressive dyspnea within 7 days (100mmHg \< PaO2/FiO2≤200, PEEP≥5cmH2O); ② Hypoxemia: SpO2/FiO2≤315mmHg and SpO2≤97%, and could not be explained by acute heart failure and fluid overload; ③ Need intubation or mechanical ventilation; ④ Imaging findings (chest X-ray/chest CT) : infiltration of both lungs, cannot be completely explained by pleural effusion, lobar/whole lung atelectasis and nodule; 4. There was no uncured pneumonia, interstitial lung disease, or chronic respiratory failure before the onset of the disease. 5. Able and willing to sign written informed consent and comply with the requirements of the research protocol. Exclusion Criteria: 1. Patients diagnosed with severe intracerebral hemorrhage requiring surgical intervention with decompressive craniotomy or critically ill, near death; 2. Diagnosis of aneurysm, brain tumor, arteriovenous malformation requires surgery; 3. Recently received live or attenuated vaccine; other JAK inhibitors or other organisms are being used, or enrolled in other clinical trials; 4. Combine the following cases that are not eligible to participate in this study: ① Severe hepatic insufficiency (ALT/AST \> 5xULN); ② Moderate to severe renal insufficiency (eGFR \< 60ml/min/1.73m2); ③ Undergoing hemodialysis or hemofiltration; ④ Neutrophils or lymphocytes decreased (Absolute neutrophil count \< 1000/ul, absolute lymphocyte count \< 200/ul); ⑤ During pregnancy or childbirth; 5. Venous thromboembolism or risk of thrombosis; 6. Life expectancy after enrollment ≤24h.
Where this trial is running
Tianjin, Tianjin Municipality
- Tianjin Medical University General Hospital — Tianjin, Tianjin Municipality, China (Recruiting)
Study contacts
- Study coordinator: Qiang Liu, M.D, Ph.D.
- Email: qliu@tmu.edu.cn
- Phone: +86 15022439149
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.