Baricitinib for Moderate and Severe Traumatic Intracerebral Hemorrhage/Contusions

Launched by TANG-DU HOSPITAL · Sep 26, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a medication called baricitinib on people who have experienced moderate to severe traumatic brain injuries, specifically those with bleeding or bruising inside the brain. The goal is to see if this medication can improve outcomes for patients who are admitted to the hospital within 24 hours of their injury. To be eligible for the study, participants need to be between 18 and 80 years old, have a confirmed traumatic brain injury, and have a specific level of consciousness when they arrive at the hospital.

If you or a loved one qualify for this trial, you will be randomly assigned to receive either baricitinib or a placebo (a non-active treatment) during your hospital stay. The study aims to gather important information about how well baricitinib works in this situation. Before participating, consent will be obtained from you or your representative, ensuring that you understand what to expect. It’s important to note that certain medical conditions or situations, such as pregnancy or recent serious infections, may prevent someone from being eligible for the trial.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age 18 years older and younger than 80 years old.
• • 2. Definite history of traumatic brain injury.
• • 3. Admission within≤24 hours after the traumatic brain injury.
• • 4. CT scans demonstrate intracerebral hemorrhage/contusions with and without extracerebral hemorrhage (epi- and sub- dural hemorrhage)
• • 5. GCS score of 5 or greater and no more than 12 at time of enrollment.
• • 6. Closed head injury.
• • 7. Admission without infections
• • 8. Signed and dated informed consent by the subject, legally authorized representative, or surrogate obtained.
• Exclusion Criteria:
• • 1. Time of head injury cannot be reliably assessed.
• • 2. Subjects is considered a candidate for immediate surgical intervention because of severe extracranial injury.
• • 3. Open head injury.
• • 4. Pregnancy or parturition within previous 30 days or active lactation.
• • 5. Use of Janus kinase inhibitors (baricinitib,abroctinib, AG490 and etc.)
• • 6. Pre-traumatic dementia or disability.
• • 7. With severe liver, kidney disease, or malignancy, life expectancy is less than 14 days.
• • 8. Severe pulmonary infection.
• • 9. Severe or acute heart failure.
• • 10. Severe infections within previous 30 days.
• • 11. History of myocardial infarction.
• • 12. Known sensitivity to baricinitib.
• • 13. Severe decreases in neutrophil, lymphocyte and platelet counts, severe decrease in hemoglobin.
• • 14. Severe liver and kidney dysfunction.
• • 15. Currently participating in other interventional clinical trials.