Efficacy and Safety of Baricitinib in the Post-intracerebral Hemorrhage Pulmonary Injury
NCT Number: NCT06548802
Acronym: BRIGHT
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: Pulmonary Injury After Intracerebral Hemorrhage
Interventions: DRUG: Baricitinib
Sponsor: Tianjin Medical University General Hospital
Collaborators: First Affiliated Hospital of Fujian Medical University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-02-29
Completion Date: 2026-06
Locations: Tianjin Medical University General Hospital, Tianjin, Tianjin, 300052, China

Summary:
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.

Primary Outcome Measures: 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., From day 1 to day 30 after the lung injury occurrence.
Secondary Outcome Measures: 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., 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)., 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, 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., 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., 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.