Tranexamic Acid Infusion During Elective Spine Surgery
试验速览
- 阶段
- 4 期
- 状态
- Enrolling By Invitation
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Drain output
研究概览
简要总结
Tranexamic acid (TXA) is an agent that has been shown to be safe and effective to reduce blood loss in surgical procedures. The purpose of the study is to assess the effect of transexamic on elective decompressive lumbar spine surgery with and without fusion.
详细描述
This will be a prospective randomized control, double-blinded investigation. The Investigators will recruit patients undergoing elective, primary, decompressive lumbar surgery via a posterior surgical approach of less than 3 levels. This includes patients undergoing decompressive lumbar laminectomies with or without fusion. Fusion may include posterior interbody and/or posterior lateral techniques with instrumentation.
There will be 3 treatment arms with the goal of 65 patients in each arm. Patients will be randomized pre-operatively and enrolled into the IV transexamic acid group (receiving intraoperative intravenous tranexamic acid infusion), or the topical transexamic acid group or the control/placebo group (receiving intraoperative intravenous saline). The Investigators expect the duration of each treatment group to be approximately 4-5 months. Therefore, the study should be completed within 1.5 years. The primary surgeon and anesthesia staff will not be blinded to the treatment arm due to the nature of the different administration routes, but post-operative nursing staff will be blinded to administration routes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing decompressive lumbar laminectomy with or without fusion
- •Primary surgical procedure
- •Competent adult able to give informed consent
排除标准
- •h/o DVT or PE
- •h/o seizure
- •h/o coagulopathy
- •Diagnosis of malignancy or infection as indication for surgical decompression
- •Abnormal pre-operative PT/INR, aPTT, bleeding time
- •Platelet count < 100
- •Patients requiring therapeutic heparin or lovenox bridges prior to and/or after surgery
- •Allergy to TXA
- •Pregnant women and prisoners
- •Renal insufficiency
研究组 & 干预措施
IV-transexemic acid
weight adjusted standard dose of TXA will be administered to these subset of patients prior to incision in IV-form
干预措施: Tranexamic Acid (Drug)
Topical-transexemic acid
the wound site after the surgery is completed will be bathed in TXA for a standardized period of time prior to skin closure
干预措施: Tranexamic Acid (Drug)
结局指标
主要结局
Drain output
时间窗: 48 hours postoperatively
Drains will be placed during surgery, this will be recorded by nursing staff on a regular schedule and we will assess the results as a surrogate for blood loss post operatively
次要结局
- Change in hematocrit(two days post operatively)
- Emergency department visits(30 days post operatively)
- number of hospital readmissions(30 days post operatively)
- Incidence of DVT(30 days post opertively)
- Change in hemoglobin(two days post operatively)
- Incidence of PE(30 days post opertively)