traumatic brain injury
Conditions
Interventions
Group 1:intensive fibrinogen correction
Group 2:conventional fibrinogen correction
Sponsors
Huashan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 70 years; 2. Clear history of head trauma and traumatic intracranial lesions (acute epidural hematoma, acute subdural hematoma, brain contusion, intracerebral hematoma, diffuse axonal injury, brain stem injury, etc.) confirmed by head CT; 3. The patient was admitted to the hospital or emergency department within 12 hours after the onset of the disease, and the head CT was completed within 1 hour to confirm the presence of traumatic intracranial lesions; 4. The fibrinogen level was less than 2.0 L/h after admission.
Exclusion criteria
Exclusion criteria: 1. Patients with GCS score of 3 and bilateral fixed pupil; 2. Patients with previous brain diseases with neurological deficits or disturbance of consciousness; 3. Patients with life expectancy less than 3 days after onset of disease; 4. Pregnancy, childbirth or lactation within 30 days; 5. The patient had severe liver dysfunction before the onset of the disease; 6. The patients had decreased fibrinogen level or dysfunction before the onset of the disease; 7. The patient had congenital or acquired thrombocytopenia before onset; 8. The patients only with scalp hematoma and skull fracture confirmed by head CT; 9. The patient had no history of long-term or recent anticoagulant and antiplatelet drugs before onset.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| GOSE at 180 days after injury; | — |
Secondary
| Measure | Time frame |
|---|---|
| Mortality at 180 days after injury;Rate of progressive intracranial hemorrhage; | — |
Countries
China
Contacts
Public ContactQiang Yuan
Huashan Hospital, Fudan University
Outcome results
None listed