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Optimal Cerebral Perfusion Pressure Guided Therapy: Assessment of Target Effectiveness - II

Study acronym: Cogitate II
StatusNot Yet Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 8 months later May 1, 2028 → Jan 1, 2029
Primary endpoint reworded 1 of 1 changed
See other at-risk trials from Maastricht University Medical Center

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from May 1, 2028 to Jan 1, 2029 Show 8 more changesShow less
    • Primary endpoint(s) modified
    • Start date: May 1, 2026 to Jan 1, 2027
    • Study completion pushed from May 15, 2028 to May 15, 2029
    • Enrollment target: 60 to 62
    • Eligibility criteria expanded, about 7 words
    • Secondary endpoints revised (9)
    • Publications: details revised at 3 of 3 entries
    • Study description expanded, about 4 words
  2. Secondary endpoints: details revised at 2 of 9 entriesv2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
After severe traumatic brain injury, adequate blood flow to the brain is essential for recovery. This depends on arterial blood pressure, yet intensive care units apply fixed targets to all patients - treating every brain and patient the same. This study aims to change that. With new technology, 'optimal' blood pressure can be determined for each individual brain and treatment can be tailored accordingly. This personalized approach to neurocritical care has never been tested in a randomized controlled study before. If effective in showing reduced brain damage biomarkers, it will fundamentally transform brain injury treatment and dramatically improve recovery outcomes for patients worldwide.
Trial Details
NCT Number NCT07287358
Lead Sponsor Maastricht University Medical Center
Collaborators: Medisch Spectrum Twente, Radboud University Medical Center, Medical Center Haaglanden
Conditions
(from sponsor)		 Traumatic Brain Injury, Severe Traumatic Brain Injury, Intracranial Pressure, Cerebral Perfusion Pressure
Related terms Brain Injuries, Traumatic
Enrollment 62 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov