Clinical trial NCT04900168: Intracranial Pressure Monitoring in Moderate Traumatic Brain Injury
Official title: A Multi-center Observational Cohort Study of Management of Moderate Traumatic Brain Injury With or Without Intracranial Pressure Monitoring in Patients With Moderate Traumatic Brain Injury in China
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Moderate Traumatic Brain Injury
Keywords: Intracranial Pressure
Lead sponsor: Tang-Du Hospital
Sponsor class: OTHER
First posted: 2021-05-25
Enrollment: 832
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patient with acute moderate traumatic brain injury

Brief summary: 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.


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.

Primary outcomes:
measure: Good neurologic outcome
timeFrame: Within 6 months after traumatic brain injury
Secondary outcomes:
measure: 6 months mortality
timeFrame: Within 6 months after traumatic brain injury
measure: In-hospital mortality
timeFrame: Within 1 month after traumatic brain injury
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Tangdu Hospital
state: Shannxi Province
Study officials:
References:
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