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BRAIN-targeted Goal-directed Therapy in High-risk Patients undeRgOing Major electIve SurgEry: the BRAIN-PROMISE Study

Study acronym: BRAINPROMISE
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated October 23, 2024 (before its estimated December 2024 completion). Its status may not reflect the trial's current state.

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion date: Dec 2022 to Dec 2024
    • Study completion date: Dec 2023 to Dec 2024
    • Eligibility criteria shortened, about 2 words
    v8
  2. 2 versions Re-verified since Feb 1, 2021, no change to tracked fieldsv6-v7
  3. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Oct 2020 to Nov 17, 2020
    v5
  4. Start date: Sep 2020 to Oct 2020v4
  5. Start date: Mar 2020 to Sep 2020v3
  6. Eligibility criteria expanded, about 15 words
    • Secondary endpoints revised (7)
    • Study description expanded, about 1 word
    v2
  7. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The aim of the study is to further understand whether the use of non-invasive monitoring NIRS (Near Infrared Spectroscopy) is useful in reducing postoperative complications in high-risk patients undergoing elective surgery.
Trial Details
NCT Number NCT04266574
Lead Sponsor Istituto Clinico Humanitas
Conditions
(from sponsor)		 Surgery, Perioperative Complication
Enrollment 200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov