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Continuous Assessment of Brain Blood Perfusion in Subarachnoid Hemorrhage Patients Using Near-Infrared Spectroscopy (NIRS)

StatusNot Yet Recruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 4 months later Jun 30, 2028 → Oct 30, 2028
See other at-risk trials from University of Alabama at Birmingham

Record History

  1. Start date: Aug 3, 2026 to Oct 30, 2026 Primary completion pushed from Jun 30, 2028 to Oct 30, 2028 · Eligibility criteria expanded, about 8 words Show 2 more changesShow less
    • Primary completion pushed from Jun 30, 2028 to Oct 30, 2028
    • Eligibility criteria expanded, about 8 words
  2. Start date: Jul 1, 2026 to Aug 3, 2026v7
  3. Re-verified, no change to tracked fieldsv6
  4. Start date: Mar 2026 to Jul 1, 2026 Primary completion date: Mar 2028 to Jun 30, 2028v5 Show 1 more changeShow less
    • Primary completion date: Mar 2028 to Jun 30, 2028
  5. Start date: Dec 2025 to Mar 2026 Primary completion date: Jun 2028 to Mar 2028v4 Show 1 more changeShow less
    • Primary completion date: Jun 2028 to Mar 2028
Show 2 earlier versionsHide 2 earlier versions
  1. Primary completion date: Jun 2027 to Jun 2028 Start date: Sep 2025 to Dec 2025 · Completion date: Dec 2027 to Dec 2028v3 Show 2 more changesShow less
    • Start date: Sep 2025 to Dec 2025
    • Completion date: Dec 2027 to Dec 2028
  2. Start date: Jun 2025 to Sep 2025 Primary completion date: Mar 2027 to Jun 2027v2 Show 1 more changeShow less
    • Primary completion date: Mar 2027 to Jun 2027
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 goal of this observational study is to continuously assess cerebral autoregulation in patients with subarachnoid hemorrhage (SAH) using cerebral oximetry index (COx) and hemoglobin volume reactivity index (HVx). The main question it aims to answer is: Whether optimal perfusion pressure is dynamic and changes with time in patients with SAH, and that autoregulation is disrupted in patients during the course of SAH, contributing to delayed cerebral ischemia (DCI).
Trial Details
NCT Number NCT06932640
Lead Sponsor University of Alabama at Birmingham
Collaborators: Edwards Lifesciences
Conditions Subarachnoid Hemorrhage, Aneurysmal
Enrollment 120 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov