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

March 12, 2026 updated by: Pathomporn Pin on, M.D., Chiang Mai University

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Chiang Mai, Thailand, 50200
        • Chiang Mai University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult patients diagnosed of giant meningiomas, diameter of at least 5 cm. They were scheduling for craniotomy during 2016-2024.

Withdrawal Criteria: There are no specific withdrawal criteria listed for this study.

Ethical Consideration: Since this is a retrospective study using existing hospital electronic records, individual informed consent is not required.

Description

Inclusion Criteria:

  • Inclusion CriteriaTo be included in the study, participants must meet all of the following requirements:Age: Patients must be at least 18 years old.

Diagnosis: Patients must be diagnosed with a meningioma. Tumor Size: The tumor must be classified as "giant," defined as having a diameter of 5 cm or larger as seen on a CT scan.

Surgery Type: Patients must have undergone a craniotomy to remove the tumor. Timeframe: The surgery must have occurred between the years 2016 and 2024

Exclusion Criteria:

  • Exclusion CriteriaPatients will be excluded from the study if they meet any of the following conditions:

Recurrent Cases: Patients with a recurrent meningioma (rather than a first-time surgery).

Emergency Cases: Patients requiring an emergency craniotomy. Pregnancy: Any patient who is pregnant. Major Complications: Patients who experienced cardiac arrest during the surgery.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Exposed Group
Patients who received HES during surgery
Other: exposure to Hydroxyethyl Starch (HES) Voluven® or Volulyte® 130/0.4
did and did not receive HES (received only crystalloids or other fluids)
Non-Exposed Group
Patients who did not receive HES (received only crystalloids or other fluids).
Other: exposure to Hydroxyethyl Starch (HES) Voluven® or Volulyte® 130/0.4
did and did not receive HES (received only crystalloids or other fluids)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The cumulative incidence of re-bleeding and required re-craniotomy within 48 hours
Time Frame: 7 days
The cumulative incidence of re-bleeding and required re-craniotomy within 48 hours
7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The incidence of new-onset postoperative Acute Kidney Injury (AKI)
Time Frame: 7 days
defined by the KDIGO criteria (Serum Creatinine increase > 0.3 mg/dl > 1.5x baseline
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chiang Mai University

Investigators

  • Principal Investigator: Pathomporn Pin on, Chiang Mai University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2025

Primary Completion (Actual)

February 14, 2026

Study Completion (Actual)

March 1, 2026

Study Registration Dates

First Submitted

March 12, 2026

First Submitted That Met QC Criteria

March 12, 2026

First Posted (Actual)

March 17, 2026

Study Record Updates

Last Update Posted (Actual)

March 17, 2026

Last Update Submitted That Met QC Criteria

March 12, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ANE-2568-0034

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

This is a retrospective cohort study using electronic medical records from a single center.To protect patient privacy and maintain strict confidentiality, only the research team has authorized access to the data.The data is recorded using research codes instead of hospital identification numbers to ensure anonymity.Currently, there is no established protocol or administrative framework for sharing these specific patient records with external researchers

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Meningioma Surgery

Clinical Trials on exposure to Hydroxyethyl Starch (HES) Voluven® or Volulyte® 130/0.4

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Netherlands

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe