Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-26 @ 3:16 PM
NCT ID:
NCT07476404
Brief 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)
Detailed Description:
Background \& Rationale
HES Properties: HES is a synthetic colloid used to maintain blood volume during surgery. While newer "third-generation" HES (130/0.4) is designed to be safer, it may still interfere with blood clotting.
Coagulation Concerns: HES can reduce levels of Factor VIII and von Willebrand factor (vWF) by 50-80%, potentially leading to "dilutional coagulopathy" where the blood cannot clot effectively.
Knowledge Gap: Current evidence is inconclusive regarding whether low-to-moderate doses of HES are truly safe during the removal of large, vascular brain tumors like giant meningiomas.
Study Methodology Study Population: Adult patients (\> 18 years) who underwent craniotomy for a giant meningioma (\> 5 cm) at Maharaj Nakorn Chiang Mai Hospital between January 1, 2016, and December 31, 2024.
Data Collection: Researchers will review electronic medical records to extract data on:
Patient demographics (age, sex, ASA physical status). Surgical details (operation time, estimated blood loss). Fluid management (volume of HES, crystalloids, and blood products given). Laboratory results (pre- and post-operative Serum Creatinine)
Ethical Considerations and Privacy: As a retrospective review of existing records, there is no direct patient contact. Data will be coded to maintain strict confidentiality.Benefits: The findings will help anesthesiologists optimize fluid therapy to improve patient safety and reduce surgical risks.
Statistical Analysis Plan
1. Grouping and ComparisonIn a cohort design, patients will be grouped based on their exposure to Hydroxyethyl Starch (HES) Voluven® or Volulyte® 130/0.4:
Exposed Group: Patients who received HES during surgery. Non-Exposed Group: Patients who did not receive HES (received only crystalloids or other fluids).
Dose-Response Analysis: Patients may also be categorized by the volume of HES received (e.g., \< 500 ml vs. 500-1,000 ml vs. \> 1,000 ml) to see if higher doses correlate with higher bleeding risk.
2. Primary and Secondary Outcomes
Primary Outcome: The cumulative incidence of re-bleeding and required re-craniotomy within 48 hours.
Secondary Outcome: The incidence of new-onset postoperative Acute Kidney Injury (AKI) within 7 days, defined by the KDIGO criteria (Serum Creatinine increase \> 0.3 mg/dl or \> 1.5x baseline).
3. Analytic StatisticsRisk Estimation: We will primarily report Relative Risk (RR) or Hazard Ratios (HR) to describe the risk of bleeding in the HES group compared to the non-HES group.
Confounder Adjustment: We will use Multivariable Logistic Regression or Cox Proportional Hazards Regression to adjust for potential confounders such as age, sex, ASA grade, tumor size, and total blood loss.
Handling Continuous Data: Factors like the volume of HES and estimated blood loss (EBL) will be analyzed using mean/standard deviation and compared using t-tests or Mann-Whitney U tests.
Sample Size Consideration for Cohort Study
For a cohort study, the sample size is determined by the expected incidence of re-bleeding in the unexposed group versus the exposed group.Based on our previous data, the incidence of re-operation is approximately 1.5% to 1.6%.With we planned 9-year data collection (2016-2024), we aim to include all eligible giant meningioma cases (\> 5 cm) to maximize the power of the study.
Study:
NCT07476404
Study Brief:
Protocol Section:
NCT07476404