Baricitinib for the Lung Injury Following Spontaneous SAH (NCT06439615) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Baricitinib for the Lung Injury Following Spontaneous SAH
100 participantsStarted 2024-08-01
Plain-language summary
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.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. Age ≥18 and ≤80 years old;
✓. Diagnosed with spontaneous subarachnoid hemorrhage through imaging or lumbar puncture;
✓. Hunt-Hess score of Ⅲ-Ⅳ;
✓. Acute onset, admitted to the hospital within 24 hours of onset
Exclusion criteria
✕. Presence of lung diseases before initiation of study treatment such as chronic obstructive emphysema, bronchiectasis, lung cancer, tuberculosis, or a history of lung surgery;
✕. 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;
✕. Secondary SAH (such as traumatic SAH), or combined craniocerebral trauma, intraparenchymal hemorrhage, or peripheral organ trauma;
✕. Evidence of fever or infection already present at the time of admission;
✕. 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;
✕. Presence of contraindications for baricitinib treatment, including severe liver damage, renal dysfunction (creatinine clearance rate \<30ml/min), hypercholesterolemia, or known drug allergies;