Re-bleeding in Giant Meningioma and Intraoperative Hydroxyethyl Starch (HES) Fluid Therapy: A Retrospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- The cumulative incidence of re-bleeding and required re-craniotomy within 48 hours
研究概览
简要总结
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: 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)
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Exposed Group
Patients who received HES during surgery
干预措施: exposure to Hydroxyethyl Starch (HES) Voluven® or Volulyte® 130/0.4 (Other)
Non-Exposed Group
Patients who did not receive HES (received only crystalloids or other fluids).
干预措施: exposure to Hydroxyethyl Starch (HES) Voluven® or Volulyte® 130/0.4 (Other)
结局指标
主要结局
The cumulative incidence of re-bleeding and required re-craniotomy within 48 hours
时间窗: 7 days
The cumulative incidence of re-bleeding and required re-craniotomy within 48 hours
次要结局
- The incidence of new-onset postoperative Acute Kidney Injury (AKI)(7 days)
研究者
Pathomporn Pin on, M.D.
Associate Professor
Chiang Mai University