Actively Recruiting
Efficacy and Safety of Baricitinib in the Post-intracerebral Hemorrhage Pulmonary Injury
Led by Tianjin Medical University General Hospital · Updated on 2024-08-12
100
Participants Needed
1
Research Sites
117 weeks
Total Duration
On this page
Sponsors
T
Tianjin Medical University General Hospital
Lead Sponsor
F
First Affiliated Hospital of Fujian Medical University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Efficacy and Safety of Baricitinib in the Post-intracerebral Hemorrhage Pulmonary Injury
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female patients 18 years old or older
- Diagnosis of non-traumatic intracerebral hemorrhage or subarachnoid hemorrhage confirmed by CT scan
- Onset of moderate to severe acute respiratory distress syndrome (ARDS) within 48 hours to 7 days after admission
- Symptoms include progressive dyspnea, hypoxemia not explained by heart failure or fluid overload, need for intubation or mechanical ventilation, and lung infiltration on imaging
- No untreated pneumonia, interstitial lung disease, or chronic respiratory failure prior to lung injury
- Able and willing to provide written informed consent and follow study protocol
You will not qualify if you...
- Severe intracerebral hemorrhage requiring surgical decompressive craniotomy or critically ill and near death
- Diagnosis of aneurysm, brain tumor, or arteriovenous malformation requiring surgery
- Recent receipt of live or attenuated vaccine, use of other JAK inhibitors, or participation in other clinical trials
- Severe liver insufficiency (ALT/AST > 5 times upper limit of normal)
- Moderate to severe kidney insufficiency (eGFR < 60 ml/min/1.73m2)
- Undergoing hemodialysis or hemofiltration
- Neutrophil count < 1000/µl or lymphocyte count < 200/µl
- Pregnant or recently gave birth
- Venous thromboembolism or risk of thrombosis
- Life expectancy of 24 hours or less after enrollment
AI-Screening
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Trial Site Locations
Total: 1 location
1
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, China, 300052
Actively Recruiting
Research Team
Q
Qiang Liu, M.D, Ph.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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