A Phase 1/2 interventional study of Baricitinib in Pulmonary Injury After Intracerebral Hemorrhage, sponsored by Tianjin Medical University General Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-12.
Sponsored by Tianjin Medical University General Hospital · Phase 1/2, Interventional, and Basic science
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.
399 studies on the registry are indexed under Lung Injury; 50 are open to participants now.
This study's planned enrollment of 100 is above the median of 53 across 239 interventional studies indexed under Lung Injury.
Browse Lung Injury studies →Tianjin Medical University General Hospital is the lead sponsor of 71 studies on the registry; 30 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Drug: Baricitinib
Given 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.
Recovery time
1. If the patient only required oxygen inhalation with the mask, SpO2≥97% of days without the mask were observed. 2. If the patient has a tracheal intubation and ventilator-assisted breathing, observe the days needed for the patient to be removed from the ventilator.
Time frame: From day 1 to day 30 after the lung injury occurrence.
Hematoma volume after intracerebral hemorrhage
1. CT images of the head were obtained at 1, 14, and 90 days after diagnosis. CT scan within 24 hours after diagnosis was used as the baseline analysis. 2. If the patient is discharged from the hospital, a CT scan of the head should be performed on the 90th day if conditions permit.
Time frame: At 1, 14, and 90 days after diagnosis.
NIHSS score
Assessed according to the National Institutes of Health Stroke Scale (NIHSS), the score ranges from 0 (asymptomatic) to 42 (death).
Time frame: 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).
Time frame: 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.)
Time frame: At 1, 3, 7, 14, 30 days after diagnosis.
Murray's lung injury score
The assessment was based on Murray's lung injury score.
Time frame: At 1, 3, 7, 14 days after diagnosis.
Days without ventilator support
1. For patients with tracheal intubation and ventilator-assisted breathing, the tracheal intubation was removed after treatment, and only required mask oxygen inhalation or high flow oxygen inhalation days until discharge. 2. If the patient has been discharged from the hospital and is still on no-oxygen, mask oxygen, or high-flow oxygen at the 30th day of follow-up, 30 days is recorded.
Time frame: From diagnosis to 30 days.
Length of ICU stay
1. Duration of ICU. 2. If the patient has not reached 30 days by the time of discharge, the 30-day telephone follow-up: * If the patient did not continue ICU treatment, the actual number of days was recorded; * If the patient remains hospitalized in the ICU, 30 days is recorded. 3. In case of death, 30 days are recorded.
Time frame: From diagnosis to 30 days.
APACHEⅡ score
Assessed according to acute physiology and chronic health evaluation Ⅱ (APACHEⅡ) on a scale of 0-60.
Time frame: At 1, 14, 30 days after diagnosis.
Total hospitalization days
Total hospitalization days.
Time frame: From diagnosis to 90 days.
Mortality
Mortality of patients died because of the lung injury after ICH.
Time frame: At 14, 30 and 90 days after diagnosis.
Incidence of treatment-emergent adverse events [safety and tolerability
Adverse events related to baricitinib are recorded.
Time frame: From diagnosis to 90 days.
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Tianjin Medical University General Hospital