Association Between Perioperative Bleeding and Aspirin Use in Spine Surgery: A Randomized, Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Hemorrhage: Amount of blood loss
研究概览
简要总结
The investigators would like to further the current understanding of aspirin and its effects on perioperative bleeding by conducting a randomized controlled trial of spinal surgery patients receiving varying doses of aspirin or no aspirin perioperatively. The investigators hypothesize that there will be no significant difference in perioperative blood loss between the different groups.
详细描述
Selected patients will be given either no aspirin, low-dose aspirin (81 mg), or high-dose aspirin (325 mg) in the perioperative period. These dosages are based on the Pharmacist's letter/Prescriber's letter which provides aspirin dosing recommendations for varying cardiovascular indications. Allocation of dosing will be based on computerized randomization in order to achieve approximately 100 patients in each group. Patient records will then be assessed for demographic characteristics, comorbidities, symptoms, functional outcome scores (Sf-12), operative time, intraoperative estimated blood loss, postoperative blood loss in drainage tubes (when applicable), cumulative blood loss, transfusion of blood products, hemoglobin level, preoperative International Normalized Ratio (INR), preoperative platelet count, hospital length of stay, and morbidity and mortality including development of NSTEMI, atrial fibrillation, surgical site infection, pulmonary embolism, and hospital 30-day readmission rates.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All patients over 18 years old, who are not taking aspirin at the time of operation as part of a current cardiovascular treatment plan, who will undergo spinal surgery from 2016-2019 in the practice of Dr. Eubanks.
排除标准
- •Any patient under the age of 18 and/or is already taking anticoagulant therapy for an established cardiovascular disease at the time of surgery as part of a cardiovascular therapy.
研究组 & 干预措施
Low-dose aspirin
Patients will be given low-dose Acetylsalicylic acid (81 mg) in the perioperative period.
干预措施: Acetylsalicylic acid (Drug)
High-dose aspirin
Patients will be given high-dose Acetylsalicylic acid (325 mg) in the perioperative period.
干预措施: Acetylsalicylic acid (Drug)
结局指标
主要结局
Hemorrhage: Amount of blood loss
时间窗: 48 hours Postoperative
Blood loss from drainage tube when applicable
次要结局
- Blood Transfusion: Amount of blood products transfused(Intraoperative)
研究者
Heather Fuhrman
medical student
University Hospitals Cleveland Medical Center