Baricitinib for Moderate and Severe Traumatic Intracerebral Hemorrhage/Contusions
ConditionTraumatic Brain Injury
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorTang-Du Hospital
About this trial
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
This trial does not accept healthy volunteersQualifiers
Age 18 years older and younger than 80 years old.
Definite history of traumatic brain injury.
Admission within≤24 hours after the traumatic brain injury.
CT scans demonstrate intracerebral hemorrhage/contusions with and without extracerebral hemorrhage (epi- and sub- dural hemorrhage)
Disqualifiers
Time of head injury cannot be reliably assessed.
Subjects is considered a candidate for immediate surgical intervention because of severe extracranial injury.
Open head injury.
Pregnancy or parturition within previous 30 days or active lactation.
Trial design
Design model
Parallel
Treatments tested in this trial
Baricitinib 4 MG
DrugBaricitinib with be be administrated orally (or crushed for nasogastric tube delivery) and given daily at the dosage of 4mg for consecutive 14 days
Standard treatment
Other interventionPatients will receive standard treatment and care according to the current management guidelines for traumatic brain injury.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Control groupSham comparator 1 intervention
Group B: Baricitinib groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Clinical improvement
Glasgow Outcome Scale at 180 days after brain trauma
Time frame
up to 180 daysSecondary outcomes
1
Mortality rate
In-hospital mortality rate, and mortality rate at 90 days, 180 days after brain trauma
Time frame
up to 180 days2
Coma severity
Glasgow Coma Scale at baseline, and at discharge
Time frame
up to 2 weeks3
Glasgow Outcome Scale
The Glasgow Outcome Scale at 90 days after brain trauma
Time frame
up to 90 days4
Serum inflammatory factors
The levels of serum inflammatory factors TNF-α、IFN-γ、IL-1β、IL-6、IL-8 at 2 to 7days after brain trauma
Time frame
up to 7 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
Tang-Du Hospital
Lead sponsor
Qianxian People's Hospital
Collaborator
Weinan Central Hospital
Collaborator
Second Affiliated Hospital of Xi'an Jiaotong University
Collaborator
The First Hospital of Yulin
Collaborator
Xidian Group Hospital
Collaborator
Chongqing University Central Hospital & Chongqing Emergency Medical Center
Collaborator
The Peoples' Hospital of Jiaozuo City
Collaborator
First People's Hospital of Xianyang
Collaborator
987th Hospital of the Chinese People's Liberation Army Joint Logistic Support Force
Collaborator
Chongqing Hospital of PAP
Collaborator
Baoji Fengxiang District Hospital
Collaborator
GEM Flower Xian Changqing Staff Hospital
Collaborator
Source ClinicalTrials.gov