The Treatment Effect of Baricitinib for the Secondary Pulmonary Complications Following Spontaneous Subarachnoid Hemorrhage

BAR-SAH

The present study is a randomized, parallel control, and double-blind trial designed to assess the efficacy of baricitinib in reducing the occurrence of pulmonary complications in patients with spontaneous subarachnoid hemorrhage (SAH). The research protocol incorporates an adaptive design, allowing for modifications to key elements such as the sample size enrolled during interim analysis.

2024-08-01

2026-12-31

2027-06-30

Not yet recruiting

Early phase I

100

Inclusion Criteria: 1. Age ≥18 and ≤80 years old; 2. Diagnosed with spontaneous subarachnoid hemorrhage through imaging or lumbar puncture; 3. Hunt-Hess score of Ⅲ-Ⅳ; 4. Acute onset, admitted to the hospital within 24 hours of onset Exclusion Criteria: 1. Presence of lung diseases before initiation of study treatment such as chronic obstructive emphysema, bronchiectasis, lung cancer, tuberculosis, or a history of lung surgery; 2. Presence of autoimmune diseases, immune system dysfunction, or blood system dysfunction (absolute lymphocyte count (ALC) less than 0.5×109 cells/L, absolute neutrophil count (ANC) less than 1×109 cells/L, or hemoglobin value less than 8 g/dL) before the onset of the disease; 3. Secondary SAH (such as traumatic SAH), or combined craniocerebral trauma, intraparenchymal hemorrhage, or peripheral organ trauma; 4. Evidence of fever or infection already present at the time of admission; 5. History of previous craniocerebral surgery, previous cerebral hemorrhage, craniocerebral injury, cerebral infarction, intracranial tumor, or presence of neurological dysfunction before the onset of the disease; 6. Presence of contraindications for baricitinib treatment, including severe liver damage, renal dysfunction (creatinine clearance rate \<30ml/min), hypercholesterolemia, or known drug allergies; 7. Taking JAK inhibitors or other immunosuppressive drugs before the onset of the disease; 8. Expected survival time less than 2 weeks; 9. Females who are pregnant or breastfeeding; 10. Currently participating in other interventional clinical studies; 11. Patients who refuse to sign the consent form or refuse to accept follow-up.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 100, 'type': 'ESTIMATED'}}

2024-06-03