Trials / Unknown
UnknownNCT06083792
ICP Threshold After Decompressive Craniectomy
ICP Threshold of Severe Traunatic Brain Injury After Decompressive Craniectomy
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 240 (estimated)
- Sponsor
- Tang-Du Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
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.
Detailed 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.
Conditions
Timeline
- Start date
- 2023-10-08
- Primary completion
- 2025-07-30
- Completion
- 2025-12-30
- First posted
- 2023-10-16
- Last updated
- 2023-10-16
Source: ClinicalTrials.gov record NCT06083792. Inclusion in this directory is not an endorsement.