Baricitinib for Moderate and Severe Traumatic Intracerebral Hemorrhage/Contusions

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.

Conditions

• Traumatic Brain Injury

Interventions

DRUG

Baricitinib 4 MG

Baricitinib with be be administrated orally (or crushed for nasogastric tube delivery) and given daily at the dosage of 4mg for consecutive 14 days

OTHER

Standard treatment

Patients will receive standard treatment and care according to the current management guidelines for traumatic brain injury.

Sponsors & Collaborators

• Qianxian People's Hospital

  collaborator UNKNOWN

• Weinan Central Hospital

  collaborator OTHER

• Second Affiliated Hospital of Xi'an Jiaotong University

  collaborator OTHER

• The First Hospital of Yulin

  collaborator UNKNOWN

• Xidian Group Hospital

  collaborator UNKNOWN

• Chongqing University Central Hospital & Chongqing Emergency Medical Center

  collaborator UNKNOWN

• The People's Hospital of Jiaozuo City

  collaborator UNKNOWN

• First People's Hospital of Xianyang

  collaborator OTHER

• The 987th Hospital of the Joint Logistics Support Force of the People's Liberation Army of China

  collaborator UNKNOWN

• Chongqing Hospital of PAP

  collaborator UNKNOWN

• Baoji Fengxiang District Hospital

  collaborator UNKNOWN

• GEM Flower Xian Changqing Staff Hospital

  collaborator UNKNOWN

• Tang-Du Hospital

  lead OTHER

Principal Investigators

• Yan Qu, M.D,Ph.D · Tang-Du Hospital

• Shunnan Ge, M.D,Ph.D · Tang-Du Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-11-24

Primary Completion

2026-06-30

Completion

2026-12-31

Countries

• China

Study Locations