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| Name | Class |
|---|---|
| First Affiliated Hospital of Fujian Medical University | OTHER |
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Some patients with intracerebral hemorrhage will develop severe lung injury such as respiratory distress syndrome. Baricitinib has been approved by the FDA for severe pneumonia caused by the coronavirus, and has been used in the treatment of hospitalized patients with COVID-19. Baricitinib significantly reduced the risk of death and shortened the length of stay in COVID-19 patients. According to clinical observations, there was no significant increase in deaths or infections due to non-COVID-19 causes during recovery, nor was there a significant increase in thrombosis. Excessive inflammatory factors release can cause inflammatory storms that damage lung cells, lead to lung injury, and eventually lead to respiratory failure, respiratory distress syndrome and other conditions, endangering life safety. Studies have shown that Baricitinib can inhibit the production of excessive pro-inflammatory cytokines by lung macrophages through the JAK pathway and reduce lung injury caused by inflammatory storms. Therefore, in patients with acute stroke with lung infection or severe lung injury, short-term use of baricitinib will help to reduce lung injury and promote the recovery of neurological function, and shorten the length of hospital stay. However, there is currently a lack of effective clinical evidence of baricitinib in the treatment of lung injury after intracerebral hemorrhage, and further research is needed.
The objective of this study was to evaluate the efficacy and safety of baricitinib in patients with pulmonary injury after intracerebral hemorrhage.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard treatment plus Baricitinib | Experimental | On standard treatment, Baricitinib was given 4mg once daily, with the first dose taken within 24 hours of the appearance of lung injury and continued for 14 days. |
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| Standard treatment | No Intervention | Given standard treatment. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Baricitinib | Drug | Baricitinib was given 4mg once daily, with the first dose taken within 24 hours of the appearance of lung injury and continued for 14 days. |
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| Measure | Description | Time Frame |
|---|---|---|
| Recovery time |
| From day 1 to day 30 after the lung injury occurrence. |
| Measure | Description | Time Frame |
|---|---|---|
| Hematoma volume after intracerebral hemorrhage |
| At 1, 14, and 90 days after diagnosis. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qiang Liu, M.D, Ph.D. | Contact | +86 15022439149 | qliu@tmu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tianjin Medical University General Hospital | Recruiting | Tianjin | Tianjin Municipality | 300052 | China |
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| ID | Term |
|---|---|
| C000596027 | baricitinib |
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| NIHSS score | Assessed according to the National Institutes of Health Stroke Scale (NIHSS), the score ranges from 0 (asymptomatic) to 42 (death). | At 1, 3, 7, 14, 30 and 90 days after diagnosis. |
| mRS score | Assessed by mRS Score on a scale of 0 (asymptomatic) to 6 (dead). | At 90 days after diagnosis. |
| Severity score | Assessed by score on a scale of 0 (asymptomatic) to 8 (dead). Scores were depended on the treatment needed (Nasal tube = 1, mask = 1, non-invasive positive pressure ventilation = 1, trachea cannula = 1, glucocorticoids treatment =1, prone position ventilation = 1, ECMO= 1, death = 1.) | At 1, 3, 7, 14, 30 days after diagnosis. |
| Murray's lung injury score | The assessment was based on Murray's lung injury score. | At 1, 3, 7, 14 days after diagnosis. |
| Days without ventilator support |
| From diagnosis to 30 days. |
| Length of ICU stay |
| From diagnosis to 30 days. |
| APACHEⅡ score | Assessed according to acute physiology and chronic health evaluation Ⅱ (APACHEⅡ) on a scale of 0-60. | At 1, 14, 30 days after diagnosis. |
| Total hospitalization days | Total hospitalization days. | From diagnosis to 90 days. |
| Mortality | Mortality of patients died because of the lung injury after ICH. | At 14, 30 and 90 days after diagnosis. |
| Incidence of treatment-emergent adverse events [safety and tolerability | Adverse events related to baricitinib are recorded. | From diagnosis to 90 days. |