Intracranial Pressure Monitoring in Moderate Traumatic Brain Injury (IPMMTBI)

Tang-Du Hospital

Status

Enrolling

Conditions

Moderate Traumatic Brain Injury

Treatments

Device: Intracranial pressure monitoring

Study type

Observational

Funder types

Other

Identifiers

NCT04900168

202102-18

Details and patient eligibility

About

Objectives The primary focus for scientific investigation is to conduct a multi-center observational study to determine if intracranial pressure (ICP) monitoring to direct treatment of patients with moderate traumatic brain injury (TBI) improves medical practice and patient outcomes in China.

Design and Outcomes This is a prospective observational cohort multi-center study with blinded evaluation of outcome. It is a 2-group design. Neurologic outcome is evaluated by extended Glasgow outcome score(GOSE) at 6 months.

Interventions and Duration This is an observational study. The decision of intracranial pressure monitoring is made by the relatives of patient. Management of all patients will be consistent with protocols presently being used in the study hospitals. For patients who received ICP monitoring, the management will also be based specifically on the presence of intracranial hypertension. Each patient will be evaluated at 6 months post injury on neurological outcomes.

Sample Size and Population 832 patients with moderate traumatic brain injury will be collected on this study.

Enrollment

832 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.