Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:33 PM
Ignite Modification Date:
2025-12-24 @ 5:33 PM
NCT ID:
NCT04900168
Eligibility Criteria:
Inclusion Criteria:
* History of head trauma
* 18 ≤ age ≤ 70 years
* Abnormal head CT scan (skull fracture, intracranial hematoma, brain contusion, cerebral infarction, brain edema, hydrocephalus, etc.)
* Glasgow coma scale at admission: 9-12
* Arriving at hospital within 24 hours after injury
* Systolic blood pressure ≥100 millimeter of mercury
* No pregnant
Exclusion Criteria:
* Refusing follow up visit
* Penetrating head injury, spine or spinal cord injury
* Surgical treatment in other hospital before admission
* Cardiopulmonary resuscitation after injury or in need of blood transfusion due to active bleeding
* Consciousness disorder caused not by head trauma (alcoholism, drug overdose, etc.)
* Prior history of head trauma or stroke
* Multiple injuries, with severity score of other parts\>18
* Rhabdomyolysis, with blood creatine kinase (CK)\>5000 international unit/L
* Injury of aorta, carotid artery or vertebral artery
* Serum creatinine (female)\>1.2mg/dL (106μmol/L), serum creatinine (male)\>1.5mg/dL (133μmol/L)
* Glomerular filtration rate (eGFR) \<60 milliliter/min
* Body mass index (BMI) \<18.5kg/m2 or \>40kg/m2
* Estimated survival time less than 1 year
* Participating in other on-going clinical researches
* Other systemic diseases: uremia, liver cirrhosis, malignant tumor, mental illness, drug, or alcohol dependence, etc.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT04900168
Study Brief:
Protocol Section:
NCT04900168