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

NCT07476404 | Completed

• 1 other identifier: ANE-2568-0034
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

Project Summary: Retrospective Cohort Study

1. 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. 2.Research Question
3. 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)

Conditions

Meningioma of Brain; Meningioma Surgery

Keywords

Re-bleeding after craniotomy to remove giant meningioma

Outcome Measures

Primary Outcomes (1)

• The cumulative incidence of re-bleeding and required re-craniotomy within 48 hours

  The cumulative incidence of re-bleeding and required re-craniotomy within 48 hours

  7 days

Secondary Outcomes (1)

• The incidence of new-onset postoperative Acute Kidney Injury (AKI)

  7 days

Study Arms (2)

Exposed Group

Patients who received HES during surgery

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

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

Interventions

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

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

Exposed Group; Non-Exposed Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chiang Mai University: lead

Study Sites (1)

Chiang Mai University

Chiang Mai, 50200, Thailand

Location

Related Publications (13)

• Vahdat S. A review of pathophysiological mechanism, diagnosis, and treatment of thrombosis risk associated with COVID-19 infection. Int J Cardiol Heart Vasc. 2022 Aug;41:101068. doi: 10.1016/j.ijcha.2022.101068. Epub 2022 Jun 3.

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• Beltrame JF, Tavella R, Zeitz CJ. Beyond Structural Angiography: The Emergence of Functional Coronary Angiography. J Am Coll Cardiol. 2022 Jun 21;79(24):2379-2382. doi: 10.1016/j.jacc.2022.04.014. No abstract available.

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• Podcast: Enigmatic neutron stars may soon give up their secrets. Nature. 2020 Jun 15. doi: 10.1038/d41586-020-01424-3. Online ahead of print. No abstract available.

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• Shanmugam S. Inverse Electrode Placement May Help to Improve Electrotherapeutic Effects in the Field of Chronic Pain Management. Korean J Pain. 2016 Jul;29(3):202-4. doi: 10.3344/kjp.2016.29.3.202. Epub 2016 Jul 1. No abstract available.

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  PMID: 24570753 RESULT

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  PMID: 26635088 RESULT

• Varughese AM, Nick TG, Gunter J, Wang Y, Kurth CD. Factors predictive of poor behavioral compliance during inhaled induction in children. Anesth Analg. 2008 Aug;107(2):413-21. doi: 10.1213/ane.0b013e31817e616b.

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• Gruber EM, Laussen PC, Casta A, Zimmerman AA, Zurakowski D, Reid R, Odegard KC, Chakravorti S, Davis PJ, McGowan FX Jr, Hickey PR, Hansen DD. Stress response in infants undergoing cardiac surgery: a randomized study of fentanyl bolus, fentanyl infusion, and fentanyl-midazolam infusion. Anesth Analg. 2001 Apr;92(4):882-90. doi: 10.1097/00000539-200104000-00016.

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• Elgellab A, Riou Y, Abbazine A, Truffert P, Matran R, Lequien P, Storme L. Effects of nasal continuous positive airway pressure (NCPAP) on breathing pattern in spontaneously breathing premature newborn infants. Intensive Care Med. 2001 Nov;27(11):1782-7. doi: 10.1007/s00134-001-1117-1. Epub 2001 Oct 31.

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• Hayek SM, Fattouh M, Dews T, Kapural L, Malak O, Mekhail N. Successful treatment of spontaneous cerebrospinal fluid leak headache with fluoroscopically guided epidural blood patch: a report of four cases. Pain Med. 2003 Dec;4(4):373-8. doi: 10.1111/j.1526-4637.2003.03037.x.

  PMID: 14750917 RESULT

• Young KW, Greenwood CE, van Reekum R, Binns MA. A randomized, crossover trial of high-carbohydrate foods in nursing home residents with Alzheimer's disease: associations among intervention response, body mass index, and behavioral and cognitive function. J Gerontol A Biol Sci Med Sci. 2005 Aug;60(8):1039-45. doi: 10.1093/gerona/60.8.1039.

  PMID: 16127110 RESULT

MeSH Terms

Conditions

Meningioma

Interventions

HES 130-0.4

Condition Hierarchy (Ancestors)

Neoplasms, Nerve Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Vascular Tissue; Meningeal Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Nervous System Diseases

Study Officials

• Pathomporn Pin on

  Chiang Mai University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 7 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 12, 2026
• First Posted: March 17, 2026
• Study Start: March 1, 2025
• Primary Completion: February 14, 2026
• Study Completion: March 1, 2026
• Last Updated: March 17, 2026

Record last verified: 2026-03

Locations

TH (1)