Baricitinib for Moderate and Severe Traumatic Intracerebral Hemorrhage/Contusions

Traumatic Brain Injury Clinical Trial

Official title: A Randomized Control Trial of Baricitinib Administration in Patients With Moderate and Severe Traumatic Intracerebral Hemorrhage/Contusions

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial Description

Traumatic brain injury (TBI) remains one of the biggest public health problems and represents a major cause of death or severe disability in young people and adults. Previous studies have confirmed that an infammatory response occurs directly after TBI, which contribute to the development of cerebral edema and swelling, a breakdown of the blood-brain barrier, and delayed neuronal cell death, thus application of agents with anti-infammatory actions may be promising to improve the functional outcomes for TBI patients. Activated Janus kinases (JAKs) play pivotal roles in intracellular signaling from cell-surface receptors for multiple cytokines implicated in the pathologic processes of TBI, selective JAK1 and JAK2 inhibitors (AG490 and abroctinib) have been shown to reduce the brain edema and improve neurological function for TBI rodents. Baricitinib, an orally available small molecule, provides reversible inhibition of JAK1 and JAK2 and has shown clinical efficacy in studies involving patients with rheumatoid arthritis, COVID-19 and alopecia areata, and was very safe for patients. Therefore, in the current study, a multicenter randomized control trial will be conducted to study the therapeutic efficacy of baricitinib for patients with moderate and severe traumatic intracerebral hemorrhage/contusions, comparing with the standard treatment only.The patients with the GCS scores of 5-12 will be enrolled according to the inclusive and exclusive criteria. The primary outcome is the Glasgow Outcome Scale at 90 days, 180 days after brain trauma. And the secondary outcome including In-hospital mortality rate, and mortality rate at 60 days, 180 days after brain trauma; Glasgow Coma Scale at discharge;The rate of patients undergo the decompressive craniectomy because of the intracranial hypertension refractory to medical treatment;Volume of edema around intracerebral hemorrhage/contusions at 3 days, 7 days after brain trauma;The mean value of intracranial pressure at 2 to 7 days after brain trauma and The incidence of in-hospital pneumonia. ;

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Cerebral Hemorrhage
• Contusions
• Hemorrhage
• Traumatic Brain Injury

• NCT number: NCT06065046
• Study type: Interventional
• Source: Tang-Du Hospital
• Contact: Shunnan Ge, M.D,Ph.D
• Phone: +8618165295569
• Email: gesn8561@fmmu.edu.cn
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: October 2023
• Completion date: December 2025