Clinical Trial

Re-bleeding in Giant Meningioma and Intraoperative Hydroxyethyl Starch (HES) Fluid Therapy

Study acronym: GM-HES
Completed
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Summary
Project Summary: Retrospective Cohort Study 1. Core ObjectiveThe primary goal is to determine if the volume of Hydroxyethyl Starch (HES) 130/0.4 (specifically Voluven® or Volulyte®) administered during the removal of giant meningiomas (tumors \> 5 cm) increases the risk of postoperative complications. 2. Research Question Does the volume of intraoperative HES solution influence the rate of re-bleeding (requiring a second surgery within 48 hours) or the development of Acute Kidney Injury (AKI) within 7 days after the initial craniotomy?Outcomes: 3. Outcomes Primary: Incidence of re-bleeding at the tumor bed requiring re-operation within 48 hours Secondary: New-onset postoperative AKI within 7 days (defined by KDIGO criteria)
Trial Details
NCT Number NCT07476404
Lead Sponsor Chiang Mai University
Conditions Meningioma of Brain, Meningioma Surgery
Enrollment 300 participants
Start Date 2025-03-01
Primary Completion 2026-02-14 (estimated)
Study Completion 2026-03-01 (estimated)
Updated on ClinicalTrials.gov 2026-03-17