Intracranial Pressure Monitoring in Moderate Traumatic Brain Injury

Last updated: July 25, 2023
Sponsor: Tang-Du Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Neurologic Disorders

Treatment

Intracranial pressure monitoring

Clinical Study ID

NCT04900168
202102-18
  • Ages 18-75
  • All Genders

Study 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

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

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 toactive 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.

Study Design

Total Participants: 832
Treatment Group(s): 1
Primary Treatment: Intracranial pressure monitoring
Phase:
Study Start date:
June 01, 2021
Estimated Completion Date:
June 30, 2024

Connect with a study center

  • Tangdu Hospital

    Xi'an, Shannxi Province
    China

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.