CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 300 enrolled
Drug / intervention
exposure to Hydroxyethyl Starch (HES) Voluven® or Volulyte® 130/0.4other
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT07476404
NCT07476404N/ACompleted

Re-bleeding in Giant Meningioma and Intraoperative Hydroxyethyl Starch (HES) Fluid Therapy: A Retrospective Cohort Study

Chiang Mai University·observational·Posted Mar 17, 2026·Updated Mar 17, 2026

In Brief

An observational study evaluating exposure to Hydroxyethyl Starch (HES) Voluven® or Volulyte® 130/0.4 for Meningioma of Brain and Meningioma Surgery. Completed, enrolled 300 participants across 1 site.

Detailed 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)

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesThailand
Collaborators--

Timeline

N/ACompletedFinished
2026
First PostedMar 17, 2026
Enrollment StartMar 1, 2025
Primary CompletionFeb 14, 2026
Study CompletionMar 1, 2026
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 4 months ago

Interventions

exposure to Hydroxyethyl Starch (HES) Voluven® or Volulyte® 130/0.4other

did and did not receive HES (received only crystalloids or other fluids)