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Clinical Trials/ISRCTN45963643
ISRCTN45963643
Active, not recruiting
未知

Pilot study on the feasibility of the methodology for a future prospective evaluation of safety and clinical benefits of the MONTE monitor, for the management of intracranial hypertension in patients with traumatic brain injury

niversitair Ziekenhuis Leuven0 sites36 target enrollmentFebruary 16, 2024

Overview

Phase
未知
Intervention
Not specified
Conditions
Not specified
Sponsor
niversitair Ziekenhuis Leuven
Enrollment
36
Status
Active, not recruiting
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
February 16, 2024
End Date
January 1, 2026
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
niversitair Ziekenhuis Leuven

Eligibility Criteria

Inclusion Criteria

  • 1\. Adult patients (age \=18 years old)
  • 2\. Severe traumatic brain injury
  • 3\. Continuous invasive intraparenchymal ICP monitoring
  • 4\. Patient requires sedation

Exclusion Criteria

  • 1\. Do\-not\-resuscitate (DNR) order
  • 2\. Bilateral dilated pupils or absence of pupil reflection
  • 3\. Pregnancy
  • 4\. Known pre\-existing neurocognitive disorders or brain dysfunctions
  • 5\. Known pre\-existing spinal cord injuries with loss of motor function
  • 6\. Primary decompressive craniectomy

Outcomes

Primary Outcomes

Not specified

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