Assessing Surgical Perioperative rIsk in Patients on chRonic aspIrN Therapy Undergoing Elective Craniotomy for Aneurysm Clipping: a Prospective Multi-center Observational Study (ASPIRIN)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Mayo Clinic
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- Postoperative Hemorrhage Rate
研究概览
简要总结
This study is looking at how taking aspirin regularly affects bleeding during and after brain surgery. Specifically, it focuses on patients who are having elective surgery to clip a brain aneurysm.
Aspirin is commonly used to prevent heart attacks and strokes, but it can also increase the risk of bleeding. Doctors often face a tough decision: should patients stop taking aspirin before surgery to reduce bleeding risk, or continue it to prevent blood clots?
To help answer this question, researchers will observe 100 patients, some who take aspirin regularly and some who don't, at hospitals in the U.S., Russia, and Italy. They will not change any treatments but will collect information about bleeding during surgery, blood test results, and CT scans after surgery.
The goal is to better understand the risks of continuing aspirin and to help doctors make safer decisions for future patients.
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
- •Age > or = 18 years old
- •Patients willing to participate and provide an informed consent
- •Patients undergoing elective craniotomy for cerebral aneurysm clipping
- •Patients on chronic low-dose (75-100 mg) aspirin daily (aspirin group) or not on aspirin therapy for at least 7 days (control group) preoperatively.
排除标准
- •Emergency craniotomy
- •Use of other antiplatelet or anticoagulant medications within 7 days prior to surgery
- •Known bleeding disorders (e.g. hemophilia, thrombocytopenia)
- •History of intracranial hemorrhage unrelated to aneurysm
- •Inability to provide informed consent
研究组 & 干预措施
Chronic aspirin
Patients on chronic aspirin
干预措施: Observation (Other)
No aspirin
Patients who are not on aspirin
干预措施: Observation (Other)
结局指标
主要结局
Postoperative Hemorrhage Rate
时间窗: 48 hours postoperatively
The incidence of postoperative hemorrhage detected on CT scans within 48 hours after surgery.
Intraoperative Blood Loss
时间窗: From start to end of surgery
Measured by the change in hemoglobin and hematocrit levels from preoperative baseline to immediate postoperative period.
次要结局
- Subjective Bleeding Severity(From start to end of surgery)
- Length of hospital stay(From end of surgery to day of discharge, up to 7 days)
- Need for Blood Transfusion(From start of surgery to day of discharge, up to 7 days)
- Surgical complications(From end of surgery to day of discharge, up to 7 days)
研究者
Shaun Gruenbaum
Principal Investigator
Mayo Clinic