NCT06065046 Baricitinib for Moderate and Severe Traumatic Intracerebral Hemorrhage/Contusions
| NCT ID | NCT06065046 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Tang-Du Hospital |
| Condition | Traumatic Brain Injury |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2023-11-24 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 100 participants in total. It began in 2023-11-24 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of the present study is to study the effect of baricitinib administration on outcome of participants with moderate and severe traumatic intracerebral hemorrhage/contusions. A multi-center randomized control trial will be conducted. Participants with a radiological diagnosis of traumatic intracerebral hemorrhage/contusions and an initial GCS score of 5-12 will be screened and enrolled in the first 24 hours after traumatic brain injury.
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.
Contact & Investigator
Yan Qu, M.D,Ph.D
STUDY CHAIR
Tang-Du Hospital
Frequently Asked Questions
Who can join the NCT06065046 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Traumatic Brain Injury. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06065046 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06065046 currently recruiting?
Yes, NCT06065046 is actively recruiting participants. Contact the research team at gesn8561@fmmu.edu.cn for enrollment information.
Where is the NCT06065046 trial being conducted?
This trial is being conducted at Xi'an, China.
Who is sponsoring the NCT06065046 clinical trial?
NCT06065046 is sponsored by Tang-Du Hospital. The principal investigator is Yan Qu, M.D,Ph.D at Tang-Du Hospital. The trial plans to enroll 100 participants.