Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 12:15 AM
Study NCT ID:
NCT07476404
Status:
COMPLETED
Last Update Posted:
2026-03-17
First Post:
2026-03-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Re-bleeding in Giant Meningioma and Intraoperative Hydroxyethyl Starch (HES) Fluid Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008579', 'term': 'Meningioma'}], 'ancestors': [{'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009383', 'term': 'Neoplasms, Vascular Tissue'}, {'id': 'D008577', 'term': 'Meningeal Neoplasms'}, {'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C485123', 'term': 'HES 130-0.4'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 300}, 'targetDuration': '7 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2026-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-03-12', 'studyFirstSubmitDate': '2026-03-12', 'studyFirstSubmitQcDate': '2026-03-12', 'lastUpdatePostDateStruct': {'date': '2026-03-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The cumulative incidence of re-bleeding and required re-craniotomy within 48 hours', 'timeFrame': '7 days', 'description': 'The cumulative incidence of re-bleeding and required re-craniotomy within 48 hours'}], 'secondaryOutcomes': [{'measure': 'The incidence of new-onset postoperative Acute Kidney Injury (AKI)', 'timeFrame': '7 days', 'description': 'defined by the KDIGO criteria (Serum Creatinine increase \\> 0.3 mg/dl \\> 1.5x baseline'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Re-bleeding after craniotomy to remove giant meningioma'], 'conditions': ['Meningioma of Brain', 'Meningioma Surgery']}, 'referencesModule': {'references': [{'pmid': '35677840', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '35710188', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '34127830', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '35884768', 'type': 'RESULT', 'citation': 'Bonnesen B, Sivapalan P, Jordan A, Pedersen JW, Bergsoe CM, Eklof J, Toennesen LL, Jensen SG, Naqibullah M, Saghir Z, Jensen JS. Risk of Malignancy in Patients with Asthma-COPD Overlap Compared to Patients with COPD without Asthma. Biomedicines. 2022 Jun 21;10(7):1463. doi: 10.3390/biomedicines10071463.'}, {'pmid': '27413488', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '26261748', 'type': 'RESULT', 'citation': 'Disseldorp DJ, Poeze M, Hannemann PF, Brink PR. Is Bone Grafting Necessary in the Treatment of Malunited Distal Radius Fractures? J Wrist Surg. 2015 Aug;4(3):207-13. doi: 10.1055/s-0035-1558831.'}, {'pmid': '24570753', 'type': 'RESULT', 'citation': 'Slawin J, Kubler P, Szczepanski A, Piatek J, Stepkowski M, Reczuch K. Radial artery occlusion after percutaneous coronary interventions - an underestimated issue. Postepy Kardiol Interwencyjnej. 2013;9(4):353-61. doi: 10.5114/pwki.2013.38865. Epub 2013 Nov 18.'}, {'pmid': '26635088', 'type': 'RESULT', 'citation': 'Zhu Z, Liang Z, Liany H, Yang C, Wen L, Lin Z, Sheng Y, Lin Y, Ye L, Cheng Y, Chang Y, Liu L, Yang L, Shi Y, Shen C, Zhou F, Zheng X, Zhu J, Liang B, Ding Y, Zhou Y, Yin X, Tang H, Zuo X, Sun L, Bei JX, Liu J, Yang S, Yang W, Cui Y, Zhang X. Discovery of a novel genetic susceptibility locus on X chromosome for systemic lupus erythematosus. Arthritis Res Ther. 2015 Dec 3;17:349. doi: 10.1186/s13075-015-0857-1.'}, {'pmid': '18633018', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '11273919', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '11810123', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '14750917', 'type': 'RESULT', 'citation': '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': '16127110', 'type': 'RESULT', 'citation': "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."}]}, 'descriptionModule': {'briefSummary': 'Project Summary: Retrospective Cohort Study\n\n1. 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.\n2. Research Question\n\n 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:\n3. 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)', 'detailedDescription': 'Background \\& Rationale\n\nHES 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.\n\nCoagulation 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.\n\nKnowledge 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.\n\nStudy 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.\n\nData Collection: Researchers will review electronic medical records to extract data on:\n\nPatient 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)\n\nEthical 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.\n\nStatistical Analysis Plan\n\n1. Grouping and ComparisonIn a cohort design, patients will be grouped based on their exposure to Hydroxyethyl Starch (HES) Voluven® or Volulyte® 130/0.4:\n\n Exposed Group: Patients who received HES during surgery. Non-Exposed Group: Patients who did not receive HES (received only crystalloids or other fluids).\n\n 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.\n2. Primary and Secondary Outcomes\n\n Primary Outcome: The cumulative incidence of re-bleeding and required re-craniotomy within 48 hours.\n\n 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).\n3. 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.\n\nConfounder 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.\n\nHandling 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.\n\nSample Size Consideration for Cohort Study\n\nFor 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients diagnosed of giant meningiomas, diameter of at least 5 cm. They were scheduling for craniotomy during 2016-2024.\n\nWithdrawal Criteria: There are no specific withdrawal criteria listed for this study.\n\nEthical Consideration: Since this is a retrospective study using existing hospital electronic records, individual informed consent is not required.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Inclusion CriteriaTo be included in the study, participants must meet all of the following requirements:Age: Patients must be at least 18 years old.\n\nDiagnosis: 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.\n\nSurgery Type: Patients must have undergone a craniotomy to remove the tumor. Timeframe: The surgery must have occurred between the years 2016 and 2024\n\nExclusion Criteria:\n\n* Exclusion CriteriaPatients will be excluded from the study if they meet any of the following conditions:\n\nRecurrent Cases: Patients with a recurrent meningioma (rather than a first-time surgery).\n\nEmergency Cases: Patients requiring an emergency craniotomy. Pregnancy: Any patient who is pregnant. Major Complications: Patients who experienced cardiac arrest during the surgery.'}, 'identificationModule': {'nctId': 'NCT07476404', 'acronym': 'GM-HES', 'briefTitle': 'Re-bleeding in Giant Meningioma and Intraoperative Hydroxyethyl Starch (HES) Fluid Therapy', 'organization': {'class': 'OTHER', 'fullName': 'Chiang Mai University'}, 'officialTitle': 'Re-bleeding in Giant Meningioma and Intraoperative Hydroxyethyl Starch (HES) Fluid Therapy: A Retrospective Cohort Study', 'orgStudyIdInfo': {'id': 'ANE-2568-0034'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Exposed Group', 'description': 'Patients who received HES during surgery', 'interventionNames': ['Other: exposure to Hydroxyethyl Starch (HES) Voluven® or Volulyte® 130/0.4']}, {'label': 'Non-Exposed Group', 'description': 'Patients who did not receive HES (received only crystalloids or other fluids).', 'interventionNames': ['Other: exposure to Hydroxyethyl Starch (HES) Voluven® or Volulyte® 130/0.4']}], 'interventions': [{'name': 'exposure to Hydroxyethyl Starch (HES) Voluven® or Volulyte® 130/0.4', 'type': 'OTHER', 'description': 'did and did not receive HES (received only crystalloids or other fluids)', 'armGroupLabels': ['Exposed Group', 'Non-Exposed Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '50200', 'city': 'Chiang Mai', 'country': 'Thailand', 'facility': 'Chiang Mai University', 'geoPoint': {'lat': 18.79038, 'lon': 98.98468}}], 'overallOfficials': [{'name': 'Pathomporn Pin on', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chiang Mai University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', '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'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chiang Mai University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Pathomporn Pin on, M.D.', 'investigatorAffiliation': 'Chiang Mai University'}}}}