Intravenous Versus Topical Use of Tranexamic Acid in Reducing Gross Hemorrhage and Transfusions of Spine Surgeries (TARGETS) : A Prospective, Randomized, Double Blind, Head-to-head Comparison Study
试验速览
- 阶段
- 不适用
- 入组人数
- 176
- 主要终点
- Perioperative Total blood loss (TBL)
研究概览
简要总结
Multilevel decompression and bone graft fusion is a most effective measure for treating degenerative lumbar spinal diseases. Yet, the surgery is commonly associated with large amount of perioperative blood loss and high demand for homologous blood transfusion. Tranexamic acid (TXA) has been proved as efficient in reducing the gross blood loss in various kinds of surgeries. However, high quality evidence of its efficacy and safety is still lacking in lumbar spinal surgeries. Besides, systemic use of TXA carries the risks of thromboembolic complications such as deep venous thrombosis and pulmonary embolism, thus the optimal drug delivery route of TXA remains undetermined. The aim of this study is to test the non-inferiority of topical TXA application to its intravenous use in multilevel decompression and bone graft fusion surgeries. A prospective, randomized, double-blind, head-to-head comparison study design will be adopted.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists(ASA)classification of physical status I-II.
- •Aged over 50yrs.
- •Patients suffering from spinal stenosis or intervertebral disc displacement and require multilevel decompression and bone graft fusion surgeries.
- •Written informed consent.
排除标准
- •ASA III-IV.
- •Age≤ 50yrs.
- •History of chronic renal dysfunction (preoperative blood creatinine> 120mmol/L), liver dysfunction (preoperative blood aspartate or alanine aminotransferase> 50 units/L) or history of coronary artery disease with stent placement.
- •Abnormal preoperative coagulation profile (preoperative prothrombin time elongation> 3s, activated partial thromboplastin time elongation> 10s, platelet counts< 100*10^9/L or >400*10^9/L, or INR> 1.4).
- •Pre-existing anemia (male< 12g/dL, female<11g/dL).
- •Long-term medications of aspirin and/or other anticoagulants.
- •Patients known as allergic to TXA.
- •Patients who have religious and/or other beliefs limiting blood transfusion.
- •Dura mater laceration and/or unexpected massive bleeding during operation.
- •Cell saver application during operation.
研究组 & 干预措施
Experimental
Loading dose: 100ml 0.9% normal saline(NS) intravenous infusion, 15-20min prior to operation initiation.
Maintenance dose: 5ml/hr 0.9% NS intravenous infusion till the last suture. Bolus dose: the wound topically irrigated with 500mg TXA in 250ml 0.9% NS for 5min. Waste fluid was then removed by suction, and the wound was closed.
干预措施: Wound topically irrigated with 500mg TXA (Drug)
Control
Loading dose: 10mg/kg tranexamic acid(TXA) in 100ml 0.9% NS intravenous infusion, 15-20min prior to operation initiation.
Maintenance dose: 1mg/kg/hr TXA intravenous infusion till the last suture. Bolus dose: the wound topically irrigated with 250ml 0.9% NS for 5min. Waste fluid was then removed by suction, and the wound was closed.
干预措施: 1mg/kg/hr TXA intravenous infusion till the last suture (Drug)
结局指标
主要结局
Perioperative Total blood loss (TBL)
时间窗: Since operation initiation till postoperative day 3 (POD3)
TBL= PBV\*（hematocrit on postoperative day 3- preoperative hematocrit）/average hematocrit; Predicted blood volume(PBV)= k1\* height\^3(m)+ k2\* weight(kg)+ k3 (female: k1=0.3561， k2=0.03308， k3=0.1833, male: k1=0.3669， k2=0.03219， k3=0.6041)
次要结局
- Visible postoperative blood loss within 24hrs(0- 24hrs postoperatively)
- Combined visible perioperative blood loss(Since operation initiation till postoperative 48hrs)
- Postoperative prothrombin time(PT)(Tested at operation completion, postoperative 24hrs and postoperative 48hrs)
- Postoperative R time(Tested at operation completion, postoperative 24hrs and postoperative 48hrs, using thromboelastography tests.)
- Postoperative K time(Tested at operation completion, postoperative 24hrs and postoperative 48hrs, using thromboelastography tests.)
- Postoperative international normalized ratio(INR)(Tested at operation completion, postoperative 24hrs and postoperative 48hrs)
- Visible postoperative blood loss within 48hrs(0- 48hrs postoperatively)
- Postoperative activated partial thromboplastin time(APTT)(Tested at operation completion, postoperative 24hrs and postoperative 48hrs)
- Postoperative lysis after 30 minutes(LY 30)(Tested at operation completion, postoperative 24hrs and postoperative 48hrs, using thromboelastography tests.)
- Perioperative transfusion amounts(Since operation initiation till postoperative 48hrs)
- Length of hospital stay(A single inpatient duration since the day of admission till the day of discharge, an average of 1 week)
- Adverse event rates(Since operation initiation till postoperative 48hrs)
- Visible intraoperative blood loss(Since operation initiation till operation completion, an average of 120min)
- Postoperative hidden blood loss (HBL)(48hrs postoperatively)
- Postoperative maximum amplitude (MA)(Tested at operation completion, postoperative 24hrs and postoperative 48hrs, using thromboelastography tests.)
- Postoperative hemoglobin nadir(Since operation completion till postoperative 48hrs)
- Total postoperative blood loss(0- 48hrs postoperatively)
- Postoperative fibrinogen level(Fbg)(Tested at operation completion, postoperative 24hrs and postoperative 48hrs)
- Perioperative transfusion rates(Since operation initiation till postoperative 48hrs)
研究者
Shugang Li
Professor
Peking Union Medical College Hospital