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Intracranial Pressure Monitoring in Moderate Traumatic Brain Injury

NCT04900168 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 832

Last updated 2023-07-27

No results posted yet for this 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.

Conditions

  • Moderate Traumatic Brain Injury

Interventions

DEVICE

Intracranial pressure monitoring

An invasive method to monitor the intracranial pressure of patient

Sponsors & Collaborators

  • Tang-Du Hospital

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-01
Primary Completion
2023-12-31
Completion
2024-06-30
FDA Device
Yes

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04900168 on ClinicalTrials.gov