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Cerebral Hemodynamic Optimization by Milrinone to Prevent Delayed Cerebral Ischemia

Study acronym: OPTIMIL
StatusUnknown
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated September 25, 2024 (before its estimated July 2025 completion). Its status may not reflect the trial's current state.

Record History

  1. Changed Registry marked status Unknown (sponsor has not verified the record since Sep 2024); last known: Recruiting
  2. Site contacts updated at 3 of 5 sitesv9
  3. Primary and study completion dates: Jul 2024 to Jul 2025 Study sites: 2 to 5 · Eligibility criteria expanded, about 7 words · Secondary endpoints: details revised at 3 of 21 entriesv8 Show 3 more changesShow less
    • Study sites: 2 to 5
    • Eligibility criteria expanded, about 7 words
    • Secondary endpoints: details revised at 3 of 21 entries

    See this version in full on ClinicalTrials.gov ↗

  4. Study sites: 1 to 2v7
  5. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1 · Start date changed from estimate of Jul 2021 to Jul 25, 2021v6 Show 2 more changesShow less
    • Study sites: 0 to 1
    • Start date changed from estimate of Jul 2021 to Jul 25, 2021
Show 4 earlier versionsHide 4 earlier versions
  1. Primary completion date: Feb 2022 to Jul 2024 Completion date: Feb 2024 to Jul 2024 · Secondary endpoints revised (21) · Study description expanded, about 1 wordv5 Show 3 more changesShow less
    • Completion date: Feb 2024 to Jul 2024
    • Secondary endpoints revised (21)
    • Study description expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  2. Start date: Feb 2021 to Jul 2021v4
  3. Start date: Sep 2020 to Feb 2021 Primary completion date: Sep 2021 to Feb 2022 · Completion date: Sep 2023 to Feb 2024v3 Show 2 more changesShow less
    • Primary completion date: Sep 2021 to Feb 2022
    • Completion date: Sep 2023 to Feb 2024
  4. Start date: Mar 2020 to Sep 2020 Primary completion date: Mar 2021 to Sep 2021 · Completion date: Mar 2023 to Sep 2023v2 Show 2 more changesShow less
    • Primary completion date: Mar 2021 to Sep 2021
    • Completion date: Mar 2023 to Sep 2023
  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 present study is a randomized, multi-center, double-blind, prospective study that tests the efficacy of intravenous milrinone to optimize cerebral hemodynamic and prevent delayed cerebral ischemia (DCI) during the high-risk period (day 4- day 14) in patients with severe subarachnoid hemorrhage due to intracranial aneurysm rupture (SAHa) (WFNS IV-V). The main objective is to evaluate, in comatose patients and / or sedated on D3 following a severe SAHa (WFNS IV -V), the effect of 10 days of milrinone versus placebo, in addition to the usual management, on the volume of DCI lesions measured on CT scan at 1 month.
Trial Details
NCT Number NCT04282629
Lead Sponsor University Hospital, Toulouse
Conditions Aneurysmal Subarachnoid Hemorrhage
Enrollment 234 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov