Intracranial Pressure Monitoring in Moderate Traumatic Brain Injury — IPMMTBI  

Moderate Traumatic Brain Injury Clinical Trial

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

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Moderate Traumatic Brain Injury
• Wounds and Injuries

• NCT number: NCT04900168
• Study type: Observational
• Source: Tang-Du Hospital
• Contact: Zhihong Li, Doctor
• Phone: +81-029-84717821
• Email: 409615390@qq.com
• Status: Recruiting
• Start date: June 1, 2021
• Completion date: June 30, 2024