Status:
RECRUITING
Efficacy and Safety of Baricitinib in the Post-intracerebral Hemorrhage Pulmonary Injury
Lead Sponsor:
Tianjin Medical University General Hospital
Collaborating Sponsors:
First Affiliated Hospital of Fujian Medical University
Conditions:
Pulmonary Injury After Intracerebral Hemorrhage
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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 coronavir...
Detailed Description
The objective of this study was to evaluate the efficacy and safety of baricitinib in patients with pulmonary injury after intracerebral hemorrhage.
Eligibility Criteria
Inclusion
- Male or female patients ≥ 18 years old;
- The diagnosis was non-traumatic intracerebral hemorrhage, subarachnoid hemorrhage (including supratentorial deep hemorrhage, lobal hemorrhage, cerebellar hemorrhage, brainstem hemorrhage, intracerebral hemorrhage, intracerebral parenchymal hemorrhage into ventricle, subarachnoid hemorrhage), which was confirmed by CT scan.
- Onset of ARDS within 48 hours to 7 days after admission (as defined by Berlin) : ① Patients with moderate to severe ARDS symptoms or progressive dyspnea within 7 days (100mmHg \< PaO2/FiO2≤200, PEEP≥5cmH2O); ② Hypoxemia: SpO2/FiO2≤315mmHg and SpO2≤97%, and could not be explained by acute heart failure and fluid overload; ③ Need intubation or mechanical ventilation; ④ Imaging findings (chest X-ray/chest CT) : infiltration of both lungs, cannot be completely explained by pleural effusion, lobar/whole lung atelectasis and nodule;
- There was no uncured pneumonia, interstitial lung disease, or chronic respiratory failure before the onset of the disease.
- Able and willing to sign written informed consent and comply with the requirements of the research protocol.
Exclusion
- Patients diagnosed with severe intracerebral hemorrhage requiring surgical intervention with decompressive craniotomy or critically ill, near death;
- Diagnosis of aneurysm, brain tumor, arteriovenous malformation requires surgery;
- Recently received live or attenuated vaccine; other JAK inhibitors or other organisms are being used, or enrolled in other clinical trials;
- Combine the following cases that are not eligible to participate in this study: ① Severe hepatic insufficiency (ALT/AST \> 5xULN); ② Moderate to severe renal insufficiency (eGFR \< 60ml/min/1.73m2); ③ Undergoing hemodialysis or hemofiltration; ④ Neutrophils or lymphocytes decreased (Absolute neutrophil count \< 1000/ul, absolute lymphocyte count \< 200/ul); ⑤ During pregnancy or childbirth;
- Venous thromboembolism or risk of thrombosis;
- Life expectancy after enrollment ≤24h.
Key Trial Info
Start Date :
February 29 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06548802
Start Date
February 29 2024
End Date
June 1 2026
Last Update
August 12 2024
Active Locations (1)
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1
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, China, 300052