Meningioma of BrainGM-HESNCT07476404
Re-bleeding in Giant Meningioma and Intraoperative Hydroxyethyl Starch (HES) Fluid Therapy
An observational study of Meningioma of Brain and Meningioma Surgery, run by Chiang Mai University at 1 site in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Meningioma of Brain, Meningioma Surgery
- What is being tested?
- exposure to Hydroxyethyl Starch (HES) Voluven® or Volulyte® 130/0.4
- How many people
- 300 participants
- Where
- 1 siteThailand
- Study dates
- 1 Mar 2025to 1 Mar 2026
- How long will I take part?
- 7 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Re-bleeding in Giant Meningioma and Intraoperative Hydroxyethyl Starch (HES) Fluid Therapy: A Retrospective Cohort Study
Project Summary: Retrospective Cohort Study
- 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.
- 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:
- 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)
Read the 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
- 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.
- 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).
- 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.
- Conditions
- Meningioma of Brain, Meningioma Surgery
- Being tested
- exposure to Hydroxyethyl Starch (HES) Voluven® or Volulyte® 130/0.4
- Keywords
- Re-bleeding after craniotomy to remove giant meningioma
- Medical subject headings
- Meningioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exposure to Hydroxyethyl Starch (HES) Voluven® or Volulyte® 130/0.4Other
did and did not receive HES (received only crystalloids or other fluids)
| Study group | Role | What they receive |
|---|---|---|
| Exposed Group | Patients who received HES during surgery Receives: 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). Receives: Other: exposure to Hydroxyethyl Starch (HES) Voluven® or Volulyte® 130/0.4 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 7 days
Secondary outcomes (1)
The incidence of new-onset postoperative Acute Kidney Injury (AKI)
defined by the KDIGO criteria (Serum Creatinine increase > 0.3 mg/dl > 1.5x baseline
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2026
- Study start1 Mar 2025
- Primary completion14 Feb 2026
- Study completion1 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Meningioma of BrainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (actual)
- Target duration
- 7 Days
Sponsor and investigators
- Lead sponsor
- Chiang Mai University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pathomporn Pin on, M.D., Chiang Mai University
- Investigators
- Pathomporn Pin on, Principal investigator, Chiang Mai University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07476404
- Sponsor's protocol ID
- ANE-2568-0034
- Acronym
- GM-HES
- Status last verified
- Mar 2026
- First submitted
- 12 Mar 2026
- Last updated
- 17 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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
Publications
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.
PubMed 35677840Beltrame 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.
PubMed 35710188Podcast: 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.
PubMed 34127830Bonnesen 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.
PubMed 35884768Shanmugam 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.
PubMed 27413488Disseldorp 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.
PubMed 26261748Slawin 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.
PubMed 24570753Zhu 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.
PubMed 26635088Varughese 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.
PubMed 18633018Gruber 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.
PubMed 11273919Elgellab 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.
PubMed 11810123Hayek 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.
PubMed 14750917Young 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.
PubMed 16127110
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Re-bleeding in Giant Meningioma and Intraoperative Hydroxyethyl Starch (HES) Fluid Therapy: A Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT07476404
- Acronym / sponsor ID
- GM-HES / ANE-2568-0034
- Conditions
- Meningioma of Brain, Meningioma Surgery
- Keywords
- Re-bleeding after craniotomy to remove giant meningioma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Chiang Mai UniversityUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 14 Feb 2026 (actual)
- Study completion
- 1 Mar 2026 (actual)
- First posted
- 17 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Project Summary: Retrospective Cohort Study
- 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.
- 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:
- 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
- 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.
- 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).
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 7 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exposed Group | – | Other: exposure to Hydroxyethyl Starch (HES) Voluven® or Volulyte® 130/0.4Patients who received HES during surgery |
| Non-Exposed Group | – | Other: exposure to Hydroxyethyl Starch (HES) Voluven® or Volulyte® 130/0.4Patients who did not receive HES (received only crystalloids or other fluids). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| exposure to Hydroxyethyl Starch (HES) Voluven® or Volulyte® 130/0.4did and did not receive HES (received only crystalloids or other fluids) | Other | Exposed Group, Non-Exposed Group |
Primary outcome
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
1 secondary outcome
The incidence of new-onset postoperative Acute Kidney Injury (AKI)
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2026.
- Results publication: PubMed 35677840Vahdat 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.
- Results publication: PubMed 35710188Beltrame 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.
- Results publication: PubMed 34127830Podcast: 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.
- Results publication: PubMed 35884768Bonnesen 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.
- Results publication: PubMed 27413488Shanmugam 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.
- Results publication: PubMed 26261748Disseldorp 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.
- Results publication: PubMed 24570753Slawin 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.
- Results publication: PubMed 26635088Zhu 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.
- Results publication: PubMed 18633018Varughese 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.
- Results publication: PubMed 11273919Gruber 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.
- Results publication: PubMed 11810123Elgellab 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.
- Results publication: PubMed 14750917Hayek 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.
- Individual participant dataSharing planned: Undecided. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pathomporn Pin on principal investigator
Chiang Mai University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Meningioma of Brain and Meningioma Surgery, run by Chiang Mai University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The cumulative incidence of re-bleeding and required re-craniotomy within 48 hours (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07476404, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2026.