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NCT06083792 Clinical Trial

ICP Threshold After Decompressive Craniectomy

Traumatic Brain Injury Clinical Trial

Official title:
ICP Threshold of Severe Traunatic Brain Injury After Decompressive Craniectomy

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06083792
Other study ID # K202307-17
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date October 8, 2023
Est. completion date December 30, 2025

Study information
Verified date October 2023
Source Tang-Du Hospital
Contact Zhihong Li
Phone +86-13709183909
Email 409615390@qq.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Severe traumatic brain injury (sTBI) is a critical disease of public health importance. Increased intracranial play a significant role in the secondary injury of TBI. Reducing the ICP is helpful in reducing the mortality of sTBI. The threshold of ICP for sTBI has been suggested. The threshold of ICP for sTBI after decompressive craniectomy is not clear.

Description:

240 sTBI patients who meet the inclusion criteria will be enrolled in the present study. All sTBI patients will be screened. If meeting the including criteria, the investigators will contact the family, explain the study, and send a consent form for review. After obtaining written consent from the family, the ICP and blood pressure will be monitored continuously until retraction of ICP sensor. A mean ICP of each patient will be calculated. The neurological outcome will be assessed at 180 days after injury. A threshold for ICP after decompressive craniectomy will be derived by analyzing the association between mean ICP and neurological outcome.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 240
Est. completion date December 30, 2025
Est. primary completion date July 30, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - history of traumatic brain injury age: 18-80 years admission GCS score=8 admitting to hospital with 24 hours after injury received decompressive craniectomy received invasive ICP monitoring Exclusion Criteria: - refuse follow-up received operation before admitting to hospital received cardio-pulmonary resuscitation after injury disturbance of consciousness caused by non-traumatic reasons prior history of traumatic brain injury or stroke expected lifetime less than 180 days admitting to other ongoing study systemic disease: uremia, liver cirrhosis, malignant tumor, mental disease, drug or alcohol dependence

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Tang-Du Hospital

Outcome
Type Measure Description Time frame Safety issue
Primary Modified Glasgow Outcome score neurological outcome 180 days after injury
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